Clinical Research

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Graduate Program

The Master of Science in Clinical Research program is designed for early-career health care professionals including physicians, dentists, pharmacists, and nurses. They will explore epidemiology and biostatistics, and learn about decision sciences, applied omics science, and translating innovation into clinical practice.

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For more information, please visit the Graduate Medical Sciences website .

The Master of Science in Clinical Research is a rigorous program that meets the needs of health professionals engaged in the full spectrum of patient-oriented research. This flexible degree program is designed for a variety of professionals, including physicians who will plan and oversee translational research and clinical trials; research nurses; study coordinators; managers in clinical research and site management organizations (CROs and SROs); and professionals in the pharmaceutical, biotechnology, and medical device industries.

Learning Objectives

Upon completion of the MS in Clinical Research , students are expected to:

  • Demonstrate the ability to design and conduct clinical research, analyze results, and answer a research question.
  • Demonstrate the ability to read and critique the clinical research literature.
  • Present clinical research findings (from literature or their own research) to peers.

Our Mission

Inspire, Instruct, Innovate. The MS in Clinical Research program is dedicated to the discovery, development, and application of knowledge as it pertains to all areas of clinical research. Our mission is to foster an engaging and effective educational environment that promotes the pursuit of outstanding teaching and learning through formal classroom and practical training. With established collaborative relationships with pharmaceutical, biotech, and academic institutions, students are provided with unique opportunities to pursue clinical research in areas that are of personal and professional interest.

We hope that the information you receive about our program encourages you to pursue your graduate degree in clinical research with us. If you are interested, click here to get your application started. We accept applications for both September and January start dates.

Degree Requirements

The program consists of three components:

  • Minimum of 32 graduate units; 22 required and 10 elective
  • Clinical research practicum; hands-on involvement in a clinical research project
  • Capstone Project; clinical research project resulting in a written research paper

Master of Science in Clinical Research degree candidates are required to complete all of the following:

A minimum of 32 units at the graduate level across four terms. These must include the following 22 units of required coursework:

  • GMS CI 631 Management of Clinical Trials (4 units), spring term
  • GMS CI 640 OL Regulatory and Compliance Issues (4 units), spring term
  • GMS CI 670 Biostatistics with Computing (4 units), fall term
  • GMS CI 675 Designing Clinical Research Studies (4 units), fall term
  • GMS CI 790 Seminar in Clinical Research (2 units), spring term
  • GMS CI 794/795 Practicum in Clinical Research (2 units), fall or spring term
  • GMS CI 804/805 Research (2 units), fall or spring term

A minimum of 10 units in elective coursework: A wide variety of courses offered in Graduate Medical Sciences will count toward elective units. A minimum of 10 units must be taken as electives or directed study. Up to 4 units across two terms may be taken as the practicum or for research. Students who have completed one or more of the required courses before matriculation may acquire “advanced standing” for that requirement. “Advanced standing” means that the student may waive the requirement but would need to replace the course requirement units by taking an elective course(s). The student would not need to retake the course requirement. To waive a course requirement, students must speak to their academic advisor and complete/submit a “Petition for Approval of Advanced Standing.” No transfer units from other BU departments or institutions will be accepted.

Completion of a minimum of 240 hours of a practicum in clinical research is required for the degree. The goal of the practicum component is to provide the student hands-on exposure to clinical research. The student will work with a mentor and will be actively involved in the development, execution, and evaluation of a clinical research project or projects. During the practicum, it is expected that the student will be exposed to some or all of the following: clinical research planning, protocol preparation, interaction with Institutional Review Boards, regulatory requirements, selection of subjects/patients for the clinical trial, study monitoring, and data analysis. The practicum may be completed with a mentor who is actively conducting clinical research studies within a clinical research or hospital setting. It may also be performed under the direction of a clinical research professional within a drug, device, or biotechnology company, a clinical research organization (CRO), or site management organization (SMO) actively involved in clinical trials.

Capstone Project  

Students in the MSCR program are required to complete a capstone project that provides a culminating experience and applies the principles and methods learned in the coursework to a real-life clinical study.

The goal of the capstone project is to demonstrate the student’s understanding of the clinical research process from both a theoretical and a practical point of view. Students conduct their capstone research in a wide variety of settings, including academic medical centers and local drug or device companies.

Students generally identify their capstone mentor and develop their capstone proposal while they are completing their coursework or practicum. The capstone project must involve the analysis and interpretation of data. Students are encouraged but are not required to conduct primary data collection. Once the final draft is approved, the student gives a short oral presentation on their capstone project to the readers, capstone mentor, MSCR students and faculty members, and any other interested parties. The purpose of the oral presentation is to demonstrate the student’s ability to (1) describe clearly the capstone topic, methods, and results, (2) demonstrate their understanding of study design and analytic principles and methods, and (3) place their research into a clinical context.

Additional Information

Students are required to abide by the rules and regulations of Graduate Medical Sciences:

  • Units toward a degree will only be obtained from a passing grade (A to B–).
  • Grades of I and C+ or lower are interpreted as failures. A student receiving such grades in a total of 8 unit hours may be terminated. A student receiving a failing grade will not be permitted to take a makeup examination.
  • A degree candidate, after completing all departmental course requirements, must register each regular term as a continuing student and pay the continuing student fee until all remaining degree requirements are completed.

Please visit the Graduate Medical Sciences website at bumc.bu.edu/gms to view detailed administrative policies and procedures.

Study Options

The MSCR program can be completed on either a part-time or full-time basis depending on the student’s goal. Most of the courses take place in the late afternoons or early evenings to accommodate those who work during the day.

The program is designed so that a full-time student may complete their coursework in one academic year, including summer. Practicum and capstone components of the program should begin near completion of the coursework and the time frame for finishing them will be determined on a student-by-student basis by the program director or assistant director. A full-time student is enrolled in 12–18 units per academic term (fall and spring).

Part-time students must register for at least 4 but not more than 11 units each academic term until all course requirements are fulfilled.

Continuing Student

Students who have completed all departmental course requirements (32 units) must register each subsequent term as continuing students until all requirements for the degree have been completed.

Nondegree Option

A number of individuals with an accredited bachelor’s degree or its international equivalent, who are uncertain as to whether they want to enroll in MSCR, have the option of taking a few of the MSCR courses as a nondegree student, and may then make their decision about completing the MSCR application process. We allow the transfer toward the MSCR degree of up to 2 MSCR courses (8 units) taken as a nondegree student. Applicants must submit a copy of the Application for Admission, indicating the specific objectives of the studies/courses sought. In addition, the applicant must submit (with the application) the nonrefundable application fee. Nondegree applicants are not eligible for University sources of financial aid or aid that requires matriculation in a degree program.

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Best Master's in Clinical Research Degree Programs_2024 badge

Best Master’s in Clinical Research Degree Programs of 2024

Written by Mary Van Keuren

Updated: April 22, 2024

Find your offline clinical-research program in minutes!

Most schools have rolling admissions and financial help so you can start your degree in a few weeks!

The best master’s degree programs in clinical research equip students with the knowledge and skills needed to conduct and manage clinical trials, contribute to medical research, and ensure compliance with regulations. Graduates may pursue roles such as clinical research coordinator, clinical research associate, or regulatory affairs specialist. According to the U.S. Bureau of Labor Statistics, medical researchers earn a median salary of $99,930 per year.

Typically completed in 18 months to two years, the program may cost around $12,000 to $30,000 a year, depending on factors such as institution, location, and program format. Generally, public and land grant institutions cost less than private colleges and universities.

How to Choose a Master’s in Clinical Research Degree Program

Choose your area of study.

When choosing your area of study, consider your career goals, interests, and strengths. Reflect on which aspects of clinical research, such as drug development, epidemiology, or regulatory affairs, align with your passion and objectives. Research different programs to evaluate their curriculum, faculty expertise, and opportunities for hands-on experience or internships. Seek guidance from professionals in the field, mentors, or alumni to gain insights into various specializations and their career prospects. Selecting an area of study that resonates with your aspirations and offers ample growth opportunities is key to a fulfilling academic journey.

Research schools and programs

Start by identifying accredited institutions known for their clinical research programs. Evaluate factors such as faculty expertise, research facilities, and curriculum relevance to your career goals. Look into program formats — online or on-campus — and consider flexibility, duration, and cost. Examine alumni outcomes, internship opportunities, and industry partnerships for practical experience and networking. Investigate accreditations and rankings to gauge program quality and reputation.

Prepare for tests and applications

Begin by familiarizing yourself with admission requirements, including standardized tests like the GRE or GMAT , and deadlines for applications. Dedicate ample time to study for these exams, utilizing study guides, practice tests, and tutoring if needed. Craft a compelling personal statement highlighting your passion for clinical research, relevant experiences, and career goals. Gather letters of recommendation from professors or professionals who can attest to your qualifications and dedication. Finally, proofread all materials meticulously to ensure they reflect your abilities and commitment accurately.

Select your program

Once you have researched accredited institutions, evaluate them based on what is most important to you. For example, if you are hoping to earn real-world experience while attending school, look for programs with a well-regarded internship component. Don’t hesitate to contact an admissions counselor to ask for their help in deciding. Investigate accreditations and rankings to gauge program quality and reputation, avoiding schools that do not have regional or national accreditation from an established accreditation body . Finally, choose a program that most closely aligns with your own priorities.

Determine how you’ll pay for your degree

Begin by researching scholarship opportunities, grants, and fellowships specific to your field. Fill out the Free Application for Federal Student Aid (FAFSA) and explore federal and private student loan options, considering interest rates, repayment terms, and eligibility criteria. Look into employer tuition reimbursement programs or sponsored educational opportunities. Create a budget to assess your financial needs and explore part-time work or assistantship opportunities to supplement income. Consider negotiating with the university for financial aid or exploring payment plans to manage tuition costs.

Best 50 Accredited Master’s in Clinical Research Degree Programs

Best Master's in Clinical Research Degree Programs_2024 badge

intelligent score 99.24

#4 GradSchoolHub #4 College choice #4 Best Value Schools #6 Social Work Degree Guide

School Information

Ypsilanti, MI

Graduation Rate: 53%

Admission Rate: 85%

Urbanicity: Suburban

School Size: Medium

Delivery Format On-Campus, Hybrid

Required Credits to Graduate 34-35

Estimated Cost per Credit Resident: $957 Non-Resident: $1,659

accreditation Higher Learning Commission

more program information Email: [email protected] Phone: 734-487-0042

intelligent score 98.46

#2 College choice #4 Social Work Degree Guide #9 GradSchoolHub #12 Best Value Schools

Charlottesville, VA

Graduation Rate: 94%

Admission Rate: 21%

School Size: Large

Delivery Format On-Campus

Required Credits to Graduate 31

Estimated Cost per Credit Resident: $860 Non-Resident: $1,450

accreditation Southern Association of Colleges and Schools Commission on Colleges

more program information Email: [email protected] Phone: 434-924-5571

intelligent score 98.02

#3 College choice #5 Best Value Schools #12 Social Work Degree Guide

La Jolla, CA

Graduation Rate: 89%

Admission Rate: 34%

Urbanicity: City

Required Credits to Graduate 40

Estimated Cost per Credit $840

accreditation Western Association of Schools and Colleges Senior College and University Commission

more program information Email: [email protected] Phone: 858-534-3554

intelligent score 97.47

#1 College choice #5 GradSchoolHub #10 Social Work Degree Guide #15 Best Value Schools

Graduation Rate: 88%

Admission Rate: 19%

Required Credits to Graduate 32

Estimated Cost per Credit $2,083

accreditation New England Commission of Higher Education

more program information Email: [email protected] Phone: 617-358-9518

intelligent score 96.78

#3 Best Value Schools #6 GradSchoolHub #8 College choice #15 Social Work Degree Guide

Saint Cloud, MN

Graduation Rate: 51%

Admission Rate: 94%

Delivery Format On-Campus, Online

Required Credits to Graduate 34-38

Estimated Cost per Credit $893

more program information Email: [email protected] Phone: 320-308-2167

intelligent score 96.11

#1 Best Value Schools

Houston, TX

Graduation Rate: 91%

Admission Rate: 58%

School Size: Small

Required Credits to Graduate 36

Estimated Cost per Credit Resident: $96 Non-Resident: $516

more program information Email: [email protected] Phone: 713-500-5116

intelligent score 95.08

#5 College choice #8 GradSchoolHub #11 Social Work Degree Guide

Graduation Rate: 62%

Admission Rate: 98%

Delivery Format Hybrid

Required Credits to Graduate 30

Estimated Cost per Credit $1,163

more program information Email: [email protected] Phone: 651-962-5500

#2 Social Work Degree Guide

Chapel Hill, NC

Graduation Rate: 90%

Admission Rate: 20%

Estimated Cost per Credit Resident: $586 Non-Resident: $1,602

more program information Email: [email protected] Phone: 919-966-7430

intelligent score 93.52

#6 College choice #8 Social Work Degree Guide

Madison, NJ

Graduation Rate: 64%

Admission Rate: 89%

Estimated Cost per Credit $918

accreditation Middle States Commission on Higher Education

more program information Email: [email protected] Phone: 800-338-8803

intelligent score 92.57

#6 Best Value Schools

Memphis, TN

Graduation Rate: 87%

Admission Rate: 75%

Estimated Cost per Credit Resident: $671 Non-Resident: $989

more program information Email: [email protected] Phone: 901-448-5538

intelligent score 90.7

Jamaica, NY

Graduation Rate: 40%

Admission Rate: 59%

Delivery Format On-Campus, Online, Hybrid

Estimated Cost per Credit Resident: $470 Non-Resident: $855

more program information Email: [email protected] Phone: 718-262-2178

intelligent score 90.20

Graduation Rate: 65%

Admission Rate: 87%

Estimated Cost per Credit Resident: $1,053 Non-Resident: $1,889

more program information Email: [email protected] Phone: 602-827-2002

intelligent score 88.61

Graduation Rate: 70%

Required Credits to Graduate 33

Estimated Cost per Credit $1,095

more program information Email: [email protected] Phone: 781-768-7330

intelligent score 88.50

Louisville, KY

Graduation Rate: 55%

Estimated Cost per Credit Resident: $791 Non-Resident: $1,606

accreditation Council on Education for Public Health

more program information Email: [email protected] Phone: 502-852-6531

intelligent score 88.05

Graduation Rate: 80%

Estimated Cost per Credit $1,380

more program information Email: [email protected] Phone: 617-879-5964

intelligent score 87.30

Rochester, NY

Admission Rate: 41%

Estimated Cost per Credit $1,970

more program information Email: [email protected] Phone: 585-275-4522

intelligent score 87.13

Augusta, GA

Graduation Rate: 46%

Admission Rate: 73%

Estimated Cost per Credit In-State: $401 Out-of-State: $1,135

more program information Email: [email protected] Phone: 706-721-3785

Discover More Options

How we rank schools.

Our chosen programs lead to a Master of Science degree in clinical research, clinical nursing research, biomedical laboratory management — or another similar title that qualifies graduates to work as a clinical researcher. The programs range from 30 to 74 credits and generally require one to two years of full-time study.

All of the schools featured in this guide are regionally accredited institutions. Many of these options also have programmatic accreditation from industry groups such as the Commission on Collegiate Nursing Education or the Council on Education for Public Health.

We evaluated each program on the basis of flexibility, faculty, course strength, cost, and reputation. Then, we calculated the Intelligent Score for each program on a scale from 0 to 100. For a more extensive explanation, check out Our Ranking Methodology .

What Can You Expect From a Master’s in Clinical Research Degree Program?

A master’s degree program in clinical research provides students with comprehensive training in conducting and managing clinical trials, analyzing data, and ensuring compliance with ethical and regulatory standards. Students can expect to learn about research methodologies, biostatistics, ethical considerations, regulatory requirements, and data management techniques. The curriculum often includes coursework in clinical trial design, protocol development, patient recruitment, and monitoring of trial progress.

Typically, a master’s program takes 1.5 to two years to complete for full-time students. Part-time options may be available, extending the duration of the program. Some programs may require students to complete a thesis or capstone project, while others may offer opportunities for internships or practical experiences in clinical research settings. Prospective students should be aware of any prerequisites or admission requirements, such as undergraduate coursework in biology, chemistry, or related fields, as well as relevant work experience or certifications. Some programs may require students to participate in in-person labs, residencies, or fieldwork experiences to gain hands-on skills and practical knowledge in clinical research methodologies and practices.

Potential courses you’ll take in a master’s in clinical research program

  • Clinical Trial Design and Management. This course covers the fundamentals of designing, implementing, and managing clinical trials. Topics include protocol development, patient recruitment strategies, informed consent procedures, data collection methods, and regulatory requirements for conducting clinical research.
  • Biostatistics and Data Analysis. Students learn statistical methods for analyzing clinical trial data, including hypothesis testing, regression analysis, survival analysis, and sample size calculation. Emphasis is placed on interpreting study results and making recommendations based on statistical findings.
  • Ethical and Regulatory Issues in Clinical Research. In this course, students examine ethical principles and regulatory guidelines governing the conduct of clinical research. Students explore topics such as patient rights, informed consent, protection of human subjects, institutional review board (IRB) processes, and good clinical practice (GCP) guidelines.
  • Pharmacology and Drug Development. This course provides an overview of pharmacological principles, drug development processes, and the role of clinical trials in evaluating drug safety and efficacy. Topics include drug mechanisms of action, pharmacokinetics, pharmacodynamics, and adverse drug reactions.
  • Clinical Research Practicum or Internship. Students gain hands-on experience through a practicum or internship in a clinical research setting. Under the supervision of experienced researchers, students may participate in various aspects of clinical trial conduct, data collection, analysis, and reporting.

Master’s in Clinical Research Degree Frequently Asked Questions

How do i apply to a master's in clinical research degree program.

To apply for your master’s program, you typically need to submit an application form along with your undergraduate transcripts, letters of recommendation, a statement of purpose, and sometimes standardized test scores. Some programs may require relevant work experience or prerequisite coursework in science or healthcare fields. It’s crucial to review each program’s specific admission requirements and deadlines. Speaking with an admissions counselor can provide valuable insights into the application process and help ensure that you meet all requirements. They can also offer guidance on crafting a strong application and addressing any questions or concerns you may have.

How much does a master's in clinical research degree cost?

The cost of your master’s degree varies depending on factors such as the institution, program format (whether it is online or in-person), and residency status. According to the National Center for Education Statistics, tuition for these programs ranges from $12,000 to $30,000 per year. However, additional expenses like textbooks, supplies, and fees should also be considered. Online programs often offer cost savings since you will not need residential housing, but they could still entail technology fees.

How long does it take to earn a master's in clinical research degree?

A master’s degree in clinical research typically takes around 1.5 to two years to complete for full-time students. Part-time enrollment may extend the duration to three to four years, depending on credit load and program flexibility. Online programs often offer more flexibility, allowing students to pace their studies according to their schedule. The total number of required credits, usually ranging from 30 to 45, also influences program length. Students should consider their academic and professional commitments when choosing between full-time and part-time enrollment to ensure they can balance their studies effectively.

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Master of Science in Clinical Research

Medical staff looking at chart

  • Program Website
  • Contact Department
  • On-Campus Component No
  • Cost $1,665.00 per credit (resident, part-time), $2,601.00 per credit (nonresident, part-time)
  • Total Credits 38
  • Credential Graduate Degree
  • Application Deadlines See program website
  • Campus Twin Cities
  • College School of Public Health
  • Department Epidemiology and Community Health

The MS in Clinical Research program is a graduate degree as well as a career development path for physician-scientists, clinical scholars, and biomedical researchers.

The program trains you to conduct patient-oriented research, directly interacting with human subjects to better understand disease, the development of therapeutic interventions, and the conduct of clinical trials. You will learn how to conduct epidemiological and behavioral studies and understand issues related to outcomes-based research, and also develop grant writing and data analytic skills.

Sample Courses

  • PUBH 6301 – Fundamentals of Clinical Research
  • PUBH 6307 – Clinical Epidemiology
  • PUBH 7420 – Clinical Trials
  • PUBH 6450 – Biostatistics I

Online Catalog

Career Outlook

There is increasing demand for well-trained individuals who can design, implement, and interpret clinical research studies. Graduates go on to be academic physicians and principal investigators at major academic institutions around the country. Some of our graduates are industry leaders.

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WHY WAIT? ADVANCE YOUR CAREER WITH A MASTER’S IN CLINICAL RESEARCH

Applications will open september 4, 2024. deadline to submit is january 15, 2025. all students are required to start in june (i.e. summer quarter), a career game changer, upcoming information session, learn more about the program.

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Master of Science in Clinical Research (MSCR)

Program details.

Minimum Credit Hours 36

Designation The MSCR in Epidemiology is a STEM-designated degree under the approved categories from the U.S. Department of Homeland Security (CIP Code 51.1401).

Application Cycle Fall

Consultation with the Director of Graduate Admissions will be required in order to be considered for admission in any semester other than Fall.

Application Deadline Priority: December 10, 2024 Final: May 13, 2025

Expected Duration 2 Years

Learning Environment Residential

Admissions Information

Who Should Apply Persons planning a career as a clinical or translational investigator who will assume leadership roles in research projects and research teams. Applicants must have completed training in a primary substantive research or clinic.

Prior Degree Required Doctoral-level professional degree (MD, PharmD, PhD, DDS, nurses with PhD, DVM, etc.) or extensive health-professional experience (RNs, PAs).

Required Prerequisites At the time of enrollment, participants will simultaneously be residents, clinical fellows, post-doctoral fellows, or junior faculty at UNC or Duke University. Each student will already be affiliated with a home academic program, reflecting the funding source (e.g. T32 or K12 funding), training program (e.g. post-doctoral fellowship) or department.

Undergraduate G.P.A. An average grade of B (cumulative GPA 3.0) or better is required. Department-wide: incoming students had a mean undergraduate GPA of 3.7

Letters of Recommendation Required 3 (academic and/or professional)

Interviews Interviews are not required. However, they can be helpful to the admissions committee if you’re in the area. Contact us to schedule a visit.

Visit Opportunities Learn about opportunities to connect with faculty, staff, and current students virtually and in person.

How To Apply

I. Complete UNC Graduate School application The Graduate School Application is a common application system for UNC Chapel Hill programs.

More Information

1. Application Fee

The UNC Graduate School application fee is $95. Information on UNC Graduate School Fee Waiver Requests

2. Faculty Interest(s)/mentor(s)

Applicants to the MSCR degree programs must indicate on the UNC Graduate School application at least 1 (up to 5 possible) faculty mentor(s) with experience in clinical research from their home clinical training program.

3. Applicant information,  including North Carolina residency information.

4. Area(s) of interest

Select up to three (3) areas of interest from the dropdown.

5. Educational history

Please upload a copy of your most recent transcript(s), including your current term grades, if applicable. (If grades are not yet available, send them to the UNC Gillings program contact as soon as they become available.) Be sure the transcript reflects the name of the institution and any degrees you received.

Applicants currently enrolled in degree programs are required to upload an unofficial transcript that includes fall semester/quarter grades.   If the application is submitted before fall grades have posted, applicants are responsible for uploading an updated transcript through the application status portal once the grades have posted.

We advise that you order two copies of your transcript(s) to be sent to you. If you are admitted and choose to enroll, UNC will require official transcript(s) showing degree(s) awarded.

6. Community standards

You will be asked about honor code, crime, academic sanction, military discharge, etc.

7. Upload your Statement of Purpose.

The essay is a critical piece of the admissions process. We will evaluate both the content of the essay and your writing skills in considering your application.

Please describe your interest in the MSCR program in a 1-2 page essay.

  • Describe your areas of interest in clinical research.
  • What types of research questions do you hope to address?
  • What types of studies do you hope to perform in the future?
  • Describe the clinical mentor support you have (or will have) in place at UNC or Duke.
  • Describe how the MSCR degree fits into your future plans.

8. Upload your resume or CV.

9. Enter names of recommenders. UNC will then send them an email with instructions for submitting a letter on your behalf.

3 Letters of Recommendations are required. We encourage references from professors or teachers (or teaching assistants) or work/research supervisors who have worked directly and closely with you and who can speak about you with specificity.

10. Report test scores, if applicable.

GRE scores are not required for application.

International applicants must submit official TOEFL or IELTS standardized test scores. Code 5816 routes to UNC. TOEFL/IELTS scores must be no more than two years old.

11. Document submission (check legibility of uploads)

Applicants should preview all documents uploaded into the application system to ensure that all documents are legible for committee review.

12. Track your progress.

You will be able to track status through the Graduate School application. Once a decision is made, you will receive an email instructing login to the Graduate School application portal to see the decision letter.

II. Application Review Process

1. Department reviews application and recommends a decision.

Time-to-decision varies. Departments make recommendations to the UNC Graduate School for admitting and denying applicants. Final decisions are rendered by the UNC Graduate School.

2. UNC Graduate School reviews department recommendation and renders a final decision:

The UNC Graduate School reviews all admissions recommendations made by programs. Once final decisions have been made, the UNC Graduate School will send the applicant an email instructing them to login to their application portal to see the decision letter.

III. Costs and Funding

When estimating costs, please visit the UNC Cashier’s Office and use the Graduate and Professional Program Tuition and Fees link. Please note that the tuition and fees of graduate programs at Gillings vary from other graduate programs at UNC.

Gillings departments and concentrations consider both domestic and international applicants for funding. Please see below for helpful tips and resources:

1. Applicants are encouraged to apply by the priority deadline to be considered for UNC Graduate School scholarships and fellowships. Departments and concentrations will decide which applicants to nominate. No additional application is required.

2. Please refer to our School’s Costs and Funding page and/or UNC-Chapel Hill’s Office of Scholarships and Student Aid (OSSA) website.

3. Apply for FEDERAL financial aid by March 1 (please verify this date via FAFSA ). If you have been admitted and completed the FAFSA form by their deadline, the UNC Office of Scholarship and Student Aid will create a financial aid package for you.

4. Funding offers through the department, such as research assistantships, are possible but not guaranteed.

5. Students positions at Gillings are posted here . The UNC Graduate School also provides resources for funding, including a listserv for incoming and current students, here .

During and After The Program

For more information on our curriculum and graduate school/career outcomes, please see our Student Handbook .

Gillings Admissions [email protected]

Mirlesna Azor Academic Coordinator [email protected]

Wayne Rosamond Director of Graduate Admissions [email protected]

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Master of Science in Clinical Research

Our mission.

Inspire, Instruct, Innovate   The MS in Clinical Research program, which is a  STEM program , is dedicated to the discovery, development, and application of knowledge as it pertains to all areas of clinical research. Our mission is to foster an engaging and effective educational environment that promotes the pursuit of outstanding teaching and learning through formal classroom and practical training. With established collaborative relationships with pharmaceutical, biotech, and academic institutions, students are provided with unique opportunities to pursue clinical research in areas that are of personal and professional interest.

The MSCR program teaches students the scientific fundamentals of human research. Courses in our curriculum provide an in-depth look at all of the key elements in clinical research, including: trial design, trial management, biostatistics, ethical issues, and clinical research regulations.

The total course requirement is 32 credit hours: 22 hours are required curriculum, including practicum and capstone project; 10 hours are elective courses. Students will also complete a research “practicum”; a hands-on involvement in a clinical research project under a scientific mentor. The final requirement for the degree is to conduct clinical research, write, and present a capstone research paper.

Learning Objectives

Upon completion of the MS in Clinical Research, students are expected to: 1.      Demonstrate the ability to design and conduct clinical research, analyze results and answer a research question. 2.      Demonstrate the ability to read and critique the clinical research literature. 3.      Present clinical research findings (from literature or their own research) to peers.

The MS in Clinical Research program’s degree requirements include:

  • Minimum of 32 graduate credits : 22 required (including practicum and capstone project), and 10 elective
  • Clinical Research Practicum : Hands-on involvement in a clinical research project
  • Capstone Project : clinical research conducted, analyzed, written, and presented by student
  • Students must be enrolled in a minimum of 4 semesters , including summer sessions, to qualify for graduation
  • Students must be enrolled in two consecutive semesters, and be enrolled in the semester in which they intend to complete their Capstone project to qualify for graduation

Program Timeline

The MSCR program can be completed on either a part-time or full-time basis. Most courses take place in the late afternoons or early evenings to accommodate working professionals. A full-time student can complete his/her coursework in one year; 4 semesters (including Summer Sessions I & II). Part-time students must register for at least 4 but not more than 11 credits each academic semester until all course requirements are fulfilled.

Practicum and capstone project components of the program should begin near completion of the coursework, and the time frame for finishing these components will be determined on a student-by-student basis by the Program Director or Assistant Director.

We also allow the transfer of up to 2 MSCR courses (taken as a non-degree student) toward the MSCR degree. Learn more about the process of applying as a non-degree student here .

Required Courses

Students must complete a minimum of 32 credits at the graduate level, including the following 18 credits in required coursework :

Designing Clinical Research Studies GMS CI 675 Fall, 4 cr
Regulatory & Compliance Issues GMS CI 640 Fall, 4 cr
Biostatistics with Computing GMS CI 670 Fall, 4 cr
Management of Clinical Trials GMS CI 631 Spring, 4 cr
Seminar in Clinical Research GMS CI 790 Spring, 2 cr

Elective Coursework

Students must also complete a minimum of 10 credits in elective coursework or directed study. A wide variety of courses offered in the Division of Graduate Medical Sciences can be taken as elective credit .  All electives must be approved by your Academic Advisor before registration.

Directed Studies in Clinical Research (GMS CI 691 or 692) allows students to explore a special topic of interest under the direction of a MSCR faculty member. Students may register for two credits of directed study by submitting a paper registration form, after the MSCR faculty member has agreed to work with the student on a specific project. Directed studies with a non-MSCR faculty member or adjunct member must first be approved by and assigned to the Director or Assistant Director of MSCR as Faculty Sponsor.

  • MSCR Directed Study form

Please note: Students who have completed one or more of the required courses before matriculation may acquire “advanced standing” for that requirement. “Advanced standing” means that the student may waive the requirement but would need to replace the course requirement by taking an elective course(s). The student would not need to retake the course requirement. To waive a course requirement, students must speak to their Academic Advisor and complete/submit a “Petition for Approval of Advanced Standing.” No transfer credits from other BU departments or institutions will be accepted.

Learn more about the Practicum and Capstone Project.

Sample Curriculum for 1 Year Program Completion:

Fall Semester:

  • GMS CI 675, 4 cr
  • GMS CI 670, 4 cr
  • GMS CI 640, 4 cr

Spring Semester:

  • GMS CI 631, 4 cr
  • GMS CI 790, 2 cr
  • Practicum, variable 2-4 cr

Summer Session 1:

  • CI 796, 2 cr
  • Capstone Research, variable 2-4 cr

Summer Session 2:

College of Graduate Studies

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Maritza Dawkins-Holnes

Program Coordinator [email protected] 843-876-2216

Daniel T. Lackland, DrPH, FACE, FAHA

Director, Masters of Science in Clinical Research Program [email protected] 843-876-1141

Master of Science in Clinical Research

Program overview.

The Master of Science in Clinical Research Program (MSCR) provides training in clinical research for healthcare professionals whose careers in academic medicine would require successful and consistent extramural funding as principal investigators on grants, implement clinical research projects and produce clinical science publications. The program prepares healthcare professionals for development and opportunities to further their skills in the clinical research environment and workforce.

The MSCR program is a component of the educational core of the South Carolina Clinical and Translational Research Institute (SCTR) and is compliant with core competencies recommended by the National Center for the Advancement of Translational Sciences. The degree is granted through the College of Graduates Studies.

Course Descriptions Curriculum Learning Objectives

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Description

The Master of Science in Clinical Research (MSCR) Program provides training in clinical research for health care professionals whose careers in academic medicine would require successful and consistent extramural funding as principal investigators on grants, implement clinical research projects and produce clinical science publications.

Application Process

All applications to the College of Graduate Studies are submitted online. If you are unable to apply online, a petition to the Office of the Dean with an explanation must be submitted for special accommodation.

In addition to the application itself the applicant must complete supplemental instruction materials specific to the program to which they are applying. These forms are provided via email once an application has been submitted (and are listed under Application Materials through program links above).

Program Information:

Ms in clinical research part-time.

MS in Clinical Research Full-Time  

The Master of Science in Clinical Research (MSCR) Program provides additional training in clinical research for professionals whose careers in academic medicine would require successfully and  consistent extramural funding as principal investigators on grants and for investigator­ industry initiated clinical research projects. The program prepares physicians, healthcare professionals and investigators at all career and training stages for development and opportunities in the clinical research environment.

Requirements

Candidates in this program will primarily be senior residents, fellows, or junior faculty. While this program specifcally targets individuals at MUSC, faculty and staff at other institutions previously trained in the health professions and other qualified professionals in healthcare who wish to develop their clinical research skills, may also enroll. Senior residents, fellows, junior faculty, or health professionals must possess:

  • a doctoral degree from an accredited school in the health/clinical sciences (e.g., M.D., Pharm. D., O. D., D. M. D., Ph. D.);
  • A bachelor's or a master's degree in the health/clinical sciences from an accredited institution of higher education (e.g., BSN, MHS)

Application Materials

  • Academic transcripts from the institution of the highest degree, as well as any professional certifications that indicate the applicant has either
  • a doctoral degree from an accredited institution in the health/clinical sciences (e.g., M.D., PharmD, O.D., D.M.D., Ph.D.)
  • a graduate or bachelor's degree in the healthcare or clinical sciences from an accredited institution of higher education (e.g., BSN, MHS)

a. Future professional goals b. Your purpose for applying to the graduate program c. Area of research interest and qualifications d. Why you chose this institution's graduate certificate program e.An acknowledgement, upon acceptance, that you will commit to all scheduled classes

  • Letters of Support stating the department's guarantee  the applicant will have protected time to commit to the program: a. For residents – from the Residency Director b. For fellows – from the Fellowship Director c. For faculty – from the Division or Department Chairperson

Please Note: For your application to be complete a transcript of your highest degree earned, and letter of support must be submitted.

Back to Program List

MS in Clinical Research Full-Time

The one year, three semester program is designed to increase the number of well-trained clinical researchers who will assume leadership roles in the design, conduct, and oversight of future multidisciplinary clinical investigations critical to the mission of the National Institute of Health (NIH). The program is designed for students who are currently pursuing doctoral degrees at MUSC.

For admission, a candidate must possess one of the following:  Bachelor or master's degree in the clinical or health sciences from a U.S. accredited institution of higher education (e.g. BSN, MHS). International applicants must have a degree equivalent to a U.S. four-year baccalaureate degree from an officially recognized institution and a letter of recommendation or support letter. Learn more about admission requirements for international applicants.

Complete the applications and submit admission materials online.  If you are unable to apply you must petition the College of Graduate Studies Office of the Dean for special accommodations with an explanation of why you are unable to apply online. In addition to the application, supplemental instruction materials specific to each program is also uploaded. These forms are provided via email once an application has been submitted and are listed above under Application Materials. Official transcripts are sent directly to the Office of Enrollment Management.

International Students

Foreign nationals are urged to submit complete information as early as possible. In addition to other official entrance credentials, applicants whose native language is not English must submit the official results of the Test of English as a Foreign Language (TOEFL or IELTS score). The TOEFL or IELTS score must not be more than two years old. Final consideration cannot be granted to an international application for admission until the official scores are received by the Office of Enrollment Management.

If an international applicant has graduated or will graduate from an institution that uses English as the language of instruction, the TOEFL may be waived upon request.

All applications to the College of Graduate Studies must be submitted online. If you are unable to apply online you must petition the Office of the Dean for special accommodation explaining why you are unable to apply online. In addition to the application must complete supplemental instruction materials specific to the program to which they are applying. These forms are provided via email once an application has been submitted and are listed above under Application Materials. 

Use of Marijuana and/or CBD Products

Marijuana is a Schedule 1 drug and is illegal to purchase in South Carolina. Apart from a narrow and limited scope of codified/documented medical exceptions, it is illegal for individuals to use marijuana/tetrahydrocannabinol (THC) in South Carolina. Although cannabidiol (CBD) products may be purchased and used in South Carolina, please be aware that CBD products may contain higher levels of THC than represented on packaging and use of CBD products can result in a positive drug screen for THC/marijuana. Be aware that current drug testing methods cannot accurately ascertain the origins of THC metabolites (i.e., whether from marijuana or CBD products). Your academic program has the authority to conduct random and/or scheduled drug testing; if your test result is reported as positive for THC metabolites (even if you only used a CBD product), your ability to be accepted into the program, progress in the program, and/or successfully complete the program may be negatively impacted.

Scholarship Eligibility

MUSC offers scholarships for which you may be eligible. Some are awarded based on academic achievement; others are awarded based on community service, for example. However, the majority of scholarships awarded at MUSC are based on financial need. This means those scholarships are only awarded to students who need some financial assistance to cover the cost of tuition and fees. If you would like to be considered for a financial need-based scholarship, you must have an up-to-date Free Application for Federal Student Aid (FAFSA) on file. Make sure you list Medical University of South Carolina on your FAFSA form, along with MUSC’s code: 003438. We encourage you to submit the FAFSA as early as possible. It is recommended to submit the FAFSA in January if you plan to enroll in the Fall.

Application Deadlines

Ms in clinical research part-time deadlines.

Fall 2024
Regular  July 1, 2023 June 19, 2024
Fall 2024
Extended June 20, 2024 August 18, 2024
Fall 2025
Regular  September 1, 2024 June 19, 2025
Fall 2025
Extended June 20, 2025 August 11, 2025

MS in Clinical Research Full-Time Deadlines

Fall 2024
Regular  July 1, 2023 June 19, 2024
Fall 2024
Extended
June 20, 2024 August 18, 2024
Fall 2025
Regular  September 1, 2024 June 19, 2025
Fall 2025
Extended June 20, 2025 August 11, 2025

MS in Clinical Research

  • Online Application: Apply Now

  • Still Accepting Applications

Clinical Research is a component of healthcare science that focuses on the safety and efficacy of medications, diagnostics, and medical treatments. There is a nationally recognized need for trained clinical researchers: as of October 29, 2014, there were over 177,000 clinical trials worldwide, with approximately 46% located in the United States (National Institute of Health Clinical Trials, http://clinicaltrials.gov ). In order to address the complex medical and dental issues facing the US and international community, a trained clinical research workforce is critical to ensure that research is aligned with the highest scientific, ethical, and regulatory standards.

Master's of Science in Clinical Research

The MS program in Clinical Research is designed to produce competent clinical researchers through a unique educational experience consisting of clinical research methodology, epidemiology and biostatistics, ethical and regulatory principles, and evidence-based healthcare. Students enrolled in the MS program come from varied professional backgrounds from across the world, including foreign and US trained dentists and physicians, pharmaceutical industry employees, academics, and students enrolled in PhD programs such as Basic Science. Graduates of the MS program in Clinical Research have obtained positions in academia, industry, and government institutions or have pursued professional degrees in medicine, dentistry, and public health. Since inception, the MS program has graduated over 150 students.

The MS in Clinical Research is an intensive, one-year, 30 credit MS degree program. The program can be taken on a part-time basis, requiring two years of study. The program consists of 24 credits of classroom coursework and 6 credits of a supervised research experience in either a clinical or academic setting. Students interested in a part-time course sequence should contact the program administrator.

FALL SEMESTER – 13 credit hours

Fundamentals of Clinical Trials I (3) Data Management (2) Epidemiology (3) Federal Regulations/Agencies (2) Clinical Research Practicum I (3)

J-TERM – 3 credit hours

Evidence-Based Healthcare (3)

SPRING SEMESTER – 14 credit hours

Clinical Trials II (3) Biostatistics (3) Bioethics and IRB (2) Scientific Writing (3) Clinical Research Practicum II (3)

Applicants to the MS program must hold a minimum of a bachelor’s degree from an accredited institution (or qualifying foreign institution). In addition, evidence of strong quantitative skills and computer literacy are critical to successful completion of the program. In submitting your application, the following items are required:

  • A completed online application
  • Official transcripts from all academic institutions attended
  • An ECE course-by-course evaluation if the applicant conferred their bachelor’s degree at a qualifying foreign institution
  • GRE is optional; however, we reserve the right to request it as part of the application process.
  • For non-U.S. applicants where English is not the official language, TOEFL scores are required
  • An updated CV/resume
  • A one-page statement of purpose describing career goals/aspirations
  •  Minimum of two letters of recommendation (either academic or professional)
  • Application fee of $100 (*See information below for Application Fee Waiver Policy)

The deadline for priority consideration for completed applications is April 1st . The admissions committee will review completed applications submitted after that date on a case by case basis, subject to availability. Applicants may be invited for interviews. Applicants will generally be notified of the admission decision within three to five weeks after submission.

NOTE: All foreign credentials must be evaluated by Educational Credential Evaluators . The course-by-course document is required. For further information, contact the program coordinator.

APPLICATION FEE WAIVER POLICY

NYU College of Dentistry is committed to recruiting a diverse student body. Fee waivers for the NYU College of Dentistry application fee are granted based on one of the following criteria:

  • Financial hardship
  • U.S. military members / U.S. veterans
  • Teach for America alumni

To request an application fee waiver for the MS program, please submit a request in writing to [email protected] prior to submitting your application.

The request should include your full name and program for which you are applying, along with the following documents:

  • Copy of your Student Aid Report (SAR) for financial hardship, or
  • Documentation of service if you meet the other criteria

If you have been out of school and do not have a SAR, you may send a copy of your most recent tax return (form 1040). Please include all pages of the tax form.

We will notify you via email once your request for an application fee waiver has been approved.

The MS program is offered in the department of Epidemiology and Health Promotion and includes renowned faculty drawn from both academia and industry. Our faculty are experts in clinical research and consist of physicians, dentists, epidemiologists, and biostatisticians that bring a breadth of knowledge to the classroom experience.

PROGRAM DIRECTOR

Ryan Richard Ruff, MPH, PhD

FULL-TIME FACULTY

Richard Niederman, DMD

Ananda P. Dasanayake, MPH, PhD, FACE

Ralph Katz, DMD, MPH, PhD, FACE

Frederick G. More, DDS

Stefanie Russell, DDS, MPH, PhD

PART-TIME FACULTY

Mal Janal, PhD

James T. Nissell

Rashmi Shrestha

Tuition and fees for the MS Program in Clinical Research can be found on the Bursar’s web site. Go to the Tuition and Fees page.

The graduate program in Clinical Research has a diverse student body. Each year, our classes are comprised of students from across the world. All international students are encouraged to apply as early as possible in the admissions cycle of the expected year of attendance (November through May 15th).

Upon acceptance in the program, all international students are required to submit their AFCOE (visa application) no later than May 15th of the year they wish to attend the program. AFCOE applications received after this date will be processed for the following academic year. For more information see website for the Office of Global Services .

For more information and all issues regarding visa applications, please contact:

Office of Global Services New York University 561 LaGuardia Place New York, NY, 10012-1402 (212) 998-4720 Contact Us

COVID-19 VACCINE-RELATED REQUIREMENTS

Mandatory Vaccinations, Boosters, and Records Upload All members of the NYU community — students, faculty, employees, vendors, affiliates, and campus visitors — are required to be fully vaccinated against COVID-19, to upload proof of their vaccination to NYU's portal, and to have that vaccination documentation accepted by NYU . NYU now also requires all members of the NYU community to receive a COVID-19 booster vaccination as soon as they are eligible and upload proof of the vaccination. NYU Dentistry also must abide by the New York State Department of Health (DOH) regulations "Prevention of COVID-19 Transmission by Covered Entities" (10 NYCRR 2.61). Please note: As of January 13, 2023, the information regarding the applicability and scope of DOH regulations is subject to change, as the regulations are subject to ongoing litigation between the state of New York and a non-NYU party. NYU is monitoring the status of the regulations and this page will be updated prior to matriculation of currently admitted students. Read the Message to all Admitted Students regarding Proof of COVID-19 Vaccination »

Contact Information

For more information, please contact: Juliana Cools Program Coordinator [email protected] (212) 998-9934

Ryan Richard Ruff, MPH, PhD Director, MS Program in Clinical Research [email protected] (212) 998-9663

Foundations of Clinical Research

This Harvard Medical School six-month, application-based certificate program provides the essential skill sets and fundamental knowledge required to begin or expand your clinical research career.

Women at computer assessing research

Associated Schools

Harvard Medical School

Harvard Medical School

What you'll learn.

Understand and apply the foundational concepts of biostatistics and epidemiology

Develop a research question and formulate a testable hypothesis

Design and begin to implement a clinical research study

Cultivate the skills required to present a clinical research study

Critically evaluate the research findings in medical literature

Synthesize crucial statistical analyses using Stata software

Course description

The Foundations of Clinical Research program is rooted in the belief that clinical research training is critical to professional development in health care. Clinical research training not only creates potential independent investigators, but also enables clinicians to advance their careers through a greater understanding of research evidence. Designed to provide learners with the foundational knowledge and skill sets required to produce high-quality clinical research, our program will lay the fundamental groundwork in epidemiology and biostatistics required for a multifaceted career in clinical research.

The overarching goal of the Foundations of Clinical Research program is to equip the next generation of researchers with the skill sets essential to evaluating evidence, understanding biostatistics, and beginning their clinical research careers. Our aim is to ensure that learners develop a strong foundation in the design, implementation, analysis and interpretation of clinical research studies.

During the program, our innovative active learning approach emphasizes the traditional tutorial system with weekly live video tutorials, seminars and symposia anchored by 3 live intense weekend online workshops.  The Foundations of Clinical Research program’s six-month online curriculum emphasizes real-time skill-based learning. 

Participants will be eligible for Associate Alumni status upon successful completion of the program. Early tuition and need-based tuition reductions may be available.

Course Outline

Live Workshops

The interactive workshop curriculum will focus on hands-on skill development through active learning. To that end, the intensive schedule is designed to accelerate the growth of high-yield clinical research skills via individual and team-based workshop exercises. Students will be immersed in a dynamic learning environment that encourages collaboration and collegial networking with faculty and peers. 

Essential elements of the workshop include instruction and practical exercises in the core concepts of biostatistics, epidemiology and research question development, as well as critical assessment of the medical literature and practical training in statistical software using real-life datasets. In addition to providing training in mentorship, academic career development and leadership, we create a supportive and active learning environment where opportunities for knowledge retention and networking abound.

Live Symposia, Tutorials and Seminars

Symposia, tutorials and seminars are mandatory and will be delivered live online and organized according to eight specific clinical research topics. 

Eight 3-Hour Symposia

  • Instruction on a specific clinical research topic (e.g., cohort study design and interpretation)
  • In-depth discussion on a related epidemiology concept (e.g., odds ratio)
  • Hands-on guidance for implementing the related analysis with statistical programming in Stata

Eight 1-Hour Tutorials

  • Interpret and report on papers related to the specific clinical research topic

Eight 1-Hour Special-Topic Seminars

  • The biostatistical and epidemiological concepts to specific clinical research topics with concrete examples

Assignments

All students will be expected to complete all assignments by the due dates. Assignments will be graded as either “pass” or “fail.”

Individual Assignment 1

Individual Research Question and Study Design

  • Generate a novel research question in the evidence-based PICO format
  • Receive expert faculty review

Individual Assignment 2

Design, Implement and Present an Original Abstract

  • Design and implement a clinical research study based on a publicly available dataset
  • Analyze and create data visualizations via a user-friendly R Shiny web app
  • Write a formal 350-word abstract suitable for submission to an international conference
  • Present a digital poster to faculty at Workshop 3

Online Lectures

Research Study Introduction 

  • Designing a Clinical Research Study I–III
  • Introduction to Evidence-Based Medicine, Systematic Review and Meta-Analysis
  • Study Design 1 – Observational
  • Study Design 2 – Randomized Controlled Trials
  • Study Design 3 – Quasi-Experimental Studies
  • Introduction to Biostatistics
  • An Investigator’s Responsibility for Protection of Research Subjects
  • How to Search PubMed
  • Overview of Evidence-Based Medicine

Statistical Programming in Stata

  • Loading Data
  • Basic Programming Commands
  • Data Cleansing
  • Data Analytics I – Central Tendency
  • Data Analytics II – Statistical Testing
  • Data Analytics III – Regression Testing

Instructors

Jamie Robertson

Jamie Robertson

Djøra Soeteman

Djøra Soeteman

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  • Masters in Clinical Research in USA

Masters in Clinical Research in USA is a dynamic and engaging program designed to provide students with a comprehensive understanding of the subject matter. This course offers a blend of theoretical knowledge and practical skills, enabling students to apply what they learn in real-world scenarios. Through a combination of lectures, discussions, and hands-on activities, students gain a deep insight into the key concepts and principles of the subject. Masters in Clinical Research in USA also encourages critical thinking, problem-solving, and collaborative learning, fostering a supportive environment for students to explore and develop their abilities. With experienced instructors and access to cutting-edge resources, the Masters in Clinical Research in USA equips students with the tools they need to excel in their chosen field and prepares them for future professional success.

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Clinical Research Management

Unthsc ms degree in crm ranked as #2 best value program in clinical research in the nation, dorota stankowska, ph.d., director of specialized masters programs.

| E-mail: [email protected]

 2024-25 Student Handbook for Clinical Research Management

Program at a Glance

  • Semester credits: 50 (on-campus/hybrid cohort) / 38 (online option)
  • Average completion time: 18 months with full-time enrollment
  • Both on-campus/hybrid (cohort) and online options are available
  • Courses are taught by distinguished educators, researchers, and industry experts
  • Enrollment for on-campus/hybrid cohort and online cohort at three starting points each year: Fall, Spring, and Summer

What is a graduate degree program in Clinical Research Management?

Clinical research involves the testing and determining the safety and efficacy of new unapproved products, including pharmaceuticals, devices, and biologics in human subjects. Clinical trials in humans (volunteers and patients) are required before marketing approval by regulatory authorities such as the U.S. Food and Drug Administration (FDA). The law that governs clinical research is spelled out in Chapter 21 of the Code of Federal Regulations (CFR). In addition to requiring and legislating clinical trials, regulatory authorities define the standards by which clinical trials are to be conducted. These standards are known as Good Clinical Practices (GCPs).

In-depth knowledge of the CFR and GCP guidelines as well as international guidelines specifically as they relate to the protection of human rights, prevention, and detection of fraud, and the use of sound scientific principles, is a fundamental requirement for clinical research professionals. These individuals are key personnel involved in the conduct of clinical trials which, in turn, are pivotal in getting new products approved and on the market.

The master’s program in Clinical Research Management provides a strong foundation upon which to build or advance a career. The rigorous curriculum focuses on providing students with a broad-based view of the biomedical sciences, as well as in-depth knowledge of regulatory requirements (CFR, GCP), ethical issues, and both the medical writing and administrative skills necessary to conduct clinical research. As part of the program, all students will complete an internship practicum in clinical studies and use this experience to write the internship practicum report pursuant to receiving the Master of Science (MS) degree. The average time to complete the degree is eighteen months with full-time enrollment.

An applicant to the Clinical Research Management program may apply to either the on-campus/hybrid cohort option or the online option. All students complete a six-month internship practicum experience or a capstone project.

Is the program offered on campus or online?

Both the on-campus/hybrid and online options are available to best meet your needs. You must choose to apply to either the on-campus/hybrid cohort or the online track.

On-Campus/Hybrid Cohort Option The on-campus/hybrid cohort option is designed for the student that works best in a team setting alongside other students with daily faculty interaction. On-campus/Hybrid students will participate in didactic lectures interacting in real time with faculty and other students. With three starting points each year (Summer, Fall & Spring) students in this program can begin classes at the time most convenient for them. The average time to complete the program is eighteen months with full-time enrollment. Visit our How to Apply website for application requirements, deadlines, and other details.

Online Track Option

The online option is designed for the student balancing work and family responsibilities with enrollment. The MS degree is completed online except for an internship practicum experience. Due to the complexity of completing an internship practicum experience in a foreign location or a remote location other than DFW, students enrolled in the online track option will have their internship practicum replaced with a capstone project worth 6 SCH. In addition to the rigorous curriculum, students will have online access to advising. With three starting points each year, students in this program can begin classes at the time most convenient for them. The average time to complete the program is eighteen months with full-time enrollment. Visit our How to Apply website for application requirements, deadlines, and other details.

Campus resources are available from Financial Aid to the Library, including Career Services and the Center for Academic Performance, without traveling to our physical location.

What can I do with a graduate degree in Clinical Research Management?

Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development.

Clinical research professionals can hold a multitude of positions either in industry, at the investigational site, or in the clinical research service profession either at a contract research organization (CRO) or a site management organization (SMO). Job titles may include, but are not restricted to, Clinical Research Associate (CRA), Clinical Research Scientist (CRS), Clinical Research Coordinator (CRC), Medical Writer, Clinical Trial Auditor, Clinical Trial Monitor, Product Safety Specialist, Clinical Research Trainer, etc. Industry (sponsor) and service professions (CRO, SMO) usually provide technical and managerial career paths and ample growth opportunities.

Typically a clinical research coordinator who has been involved with the implementation and coordination of a clinical trial at a research site (private, clinic, hospital), will advance his/her career by switching to either industry or one of the service professions. Others make the reverse switch because they prefer the interactions with the patients, or they may want to travel less than what is typically required from a clinical trial monitor. Turnover in all these industries and positions is relatively high because of the growing variety of choices clinical research professionals have, especially after they have accumulated a number of years of experience.

What are the program requirements?

Each student is responsible for the completion of the requirements for the Clinical Research Management program according to the procedures that follow. Each item must be completed in the sequence and time period indicated. Forms are subject to revision at any time and can be obtained from the CBTS Forms and Guidelines site.

  • The admissions committee will review all applicants for acceptance into the MS program in Clinical Research Management. A student must have a bachelor’s degree and must meet the general admission requirements as described in the catalog in effect at the time of application.
  • The student will be assigned a major professor and an advisory committee consisting of the major professor and an advisory committee consisting of the mentor and two other graduate faculty members. The names of these individuals will be filed on the designation of advisory committee form with the CBTS Office of Student Services. A degree plan must also be filed at this time.
  • After the coursework has been completed, the student will enroll in Internship Practicum (BMSC 5697) or a Capstone project. The student will complete a six-month unpaid internship at a site previously approved by the College of Biomedical and Translational Sciences (the College). The student is responsible for transportation to and from the site. During this time, the student will learn how to perform the duties expected of particular clinical research positions in clinical research centers such as a hospital or clinic, pharmaceutical or medical device company, a clinical research organization or site management organization. The student must be in good academic standing prior to beginning the Internship Practicum. Exceptions to this rule can only be granted by the dean or his designee. Online track students will have the option of completing a capstone project in lieu of the internship practicum.
  • A formal research proposal describing how the practicum is to be spent must be approved by the advisory committee and submitted to the College.
  • At the conclusion of the practicum/capstone project, the student will present his/her work as both oral and written reports. The oral presentation will be open to the public and will then be followed by a private defense with the advisory committee. The student must submit a first draft of the practicum report/capstone project and internship daily journal to the major professor for review prior to the public seminar. The major professor must approve the internship practicum report/capstone project report before it is distributed to the committee members by the student. The final written report should be given to the committee no later than two weeks before the formal defense. Students should coordinate the reservation of a seminar room with the CBTS Dean’s office at least one month prior to the defense. At this time the committee will either approve/or not approve the work of the internship and the report. If not approved, the student may have a chance to revise the report or repeat the practicum one time at the discretion of the committee. The major professor, together with the other members of the committee, will assign a letter grade to the practicum/capstone project. The report must be submitted in accordance with the instructions for completing graduation requirements within the deadlines for graduation published in the academic calendar. A more detailed description of the internship practicum/capstone project and report requirements may be found in the Internship Practicum Guidelines available on the CBTS Graduation website.
  • It is strongly suggested that the student and major professor, as well as the major professor and the on-site mentor, communicate on a regular basis to review the student’s progress during the practicum/capstone project.

The graphic below details the curriculum requirements.

Crm 2022

Internship Practicum (BMSC 5697) 18 SCH with practicum report/defense Total Semester Credit Hours = 50 Online Track Capstone Project 6 SCH with project report/defense Total Semester Credit Hours for Online Track = 38

Internship Practicum (BMSC 5697)

The Internship Practicum provides a hands-on training experience for the graduate student whose master’s degree will be in the specialized discipline of Clinical Research Management. The program director will identify approved, on-sight and off-campus internship opportunities in north Texas and will work to place students at suitable sites. The internship may take place either on-campus or at an approved off-campus site in the Dallas-Fort Worth-Denton Metroplex and, in some cases, at a site in other parts of the state or country. UNTHSC does not offer any remuneration to the student when he/she is enrolled in BMSC 5697 and the student should not expect to be paid as an intern.  Students will be expected to provide for their own transportation and housing needs during the internship experience. The student is expected to keep a daily journal during this experience. At the end of the practicum, the student will write a report detailing the activities of the internship. The student’s advisory committee must approve this report together with the daily journal. The student must make a formal presentation to the advisory committee and defend the work at this time. A copy of the report must be submitted within the appropriate deadlines for graduation as published in the CBTS Academic Calendar .

Capstone project (online track students only)

The capstone project is a required component of the online Clinical Research Management Master’s program that will replace the requirement of an internship practicum. The students will enroll for 3 SCH each in two semesters for a total of 6 SCH for their capstone project. The purpose of the capstone project is to equip students with the knowledge and skills required to contribute to the field of clinical research management. This individualized scholarly work may consist of a detailed case study, literature review, and data analysis project or a clinical research project, or a clinical quality improvement project. Students will be paired with a mentor from UNTHSC or our partner healthcare organizations to oversee their work. At the beginning of the capstone, the mentor and student will identify a topic or a specific problem to address or investigate. They will then construct an action plan or research proposal and the student will conduct the data analysis/literature review. At the end of the project, the student will complete a project report and do an oral presentation of the project.

This page was last modified on September 6, 2024

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Nursing Research: What It Is and Why It Matters

When people think about medical research, they often think about cutting-edge surgical procedures and revolutionary new medications. As important as those advancements are, another type of research is just as vital: nursing research.

This type of research informs and improves nursing practice. In many cases, it’s focused on improving patient care. Experienced nurses who have advanced nursing degrees and training in research design typically conduct this research.

Nurse research can explore any number of topics, from symptomology to patient diet. However, no matter the focus of a research project, nurse research can improve health care in an impressive number of ways. As experts in their field, nurse researchers can pursue a wide range of unique career advancement opportunities .

Why Nursing Research Matters: Examples of Research in Action

Research drives innovation in every industry. Given that nurses are on the front line of the health care industry, the research they do can be particularly impactful for patient outcomes. 

It Can Improve Patients’ Quality of Life

Patients diagnosed with life-threatening chronic diseases often undergo intense treatments with sometimes debilitating side effects. Nursing research is vital to helping such patients maintain a high quality of life.

For example, a 2018 study led by a nurse scientist explored why cancer patients undergoing chemotherapy frequently experience severe nausea. While the physical toll of chemotherapy contributes to nausea, the study found that patients who have factors such as children to take care of, high psychological stress, and trouble performing day-to-day tasks are often much more likely to experience nausea.

By identifying the root causes of nausea and which patients are more likely to experience it, this research allows health care professionals to develop evidence-based care practices . This can include prescribing anti-nausea medications and connecting patients to mental health professionals.

It’s Central to Making Health Care More Equitabl

A Gallup survey reports that about 38% of Americans put off seeking medical treatment due to costs. Unfortunately, cost is only one factor that prevents people from seeking treatment. Many Americans don’t live close to medical providers that can meet their needs, aren’t educated about health, or encounter discrimination.

As complex as this issue is, the National Institute of Nursing Research (NINR) asserts that the country’s nurse researchers can lead the charge in tackling it. In its strategic plan for 2022 to 2026, the institute highlights the following:

  • Nursing has long been one of the most trusted professions in the country.
  • Nurses often interact with patients, patients’ families, and communities more frequently than other health care professionals.
  • The care that nurses provide must often take environmental and social factors into account.

These traits put nurses in the position to not only research health inequity but also put their research to work in their organizations. To help make that happen, NINR often funds nurse-led research projects focused on equity and social determinants of health. With that kind of backing, the field may become more transformative than ever.

It Can Strengthen the Health Care Workforce

While nursing research can be used to improve patient care, it can also be leveraged to solve issues health care professionals face daily. Research about the state of the health care workforce during the COVID-19 pandemic is a perfect illustration.

In 2022, a team of nurse researchers published a report called Nursing Crisis: Challenges and Opportunities for Our Profession After COVID-19 in the International Journal of Nursing Practice . In it, the authors provided concrete statistics about the following:

  • Mental and physical health issues many nurses encountered
  • Effects of increased workloads and decreased nurse-to-patient ratios
  • How many nurses were planning to leave the profession altogether

As nurses themselves, the authors also offer actionable, evidence-based solutions to these issues, such as streamlining patient documentation systems and implementing employee wellness programs.

However, this type of research isn’t just important to solving workforce issues stemming from specific emergencies, such as the COVID-19 pandemic. By publishing quantifiable data about the challenges they face, nurse researchers empower other nurses and professional nursing organizations to advocate for themselves. This can help employers enact effective policies, support their nursing staff, and draw more talented people into the profession.

Career Opportunities in Nursing Research

Nurse researchers can work in any number of administrative, direct care, and academic roles. However, because nurse research often requires clinical care and data analysis skills, jobs in this field typically require an advanced degree, such as a Master of Science in Nursing (MSN).

While many more nurse research career opportunities exist, here are four career paths nurses with research experience and advanced degrees can explore.

Nurse Researcher

Nurse researchers identify issues related to nursing practice, collect data about them, and conduct research projects designed to inform practice and policy. While they often work in academic medical centers and universities, they can work for any type of health care provider as well as health care advocacy agencies.

In addition to conducting research, these professionals typically provide direct patient care. Many also write papers for peer-reviewed journals and make presentations about their work at conferences.

Clinical Research Nurse

Despite having a similar title to nurse researchers, clinical research nurses have slightly different responsibilities. These professionals are usually in charge of providing care to patients participating in medical research projects, including clinical trials and nursing research initiatives. They also typically collect data about patient progress, coordinate care between different team members, and contribute to academic papers.

Occupational Health Nurse

Also referred to as environmental health nurses, occupational health nurses serve specific communities, such as professionals in a particular industry or people who live in a particular area. They often educate their communities about relevant health risks, advocate for stronger health and safety regulations, and run wellness programs.

To carry out their duties, occupational and environmental health nurses must typically research health trends about the people they serve, including living and working conditions that put them at risk for illness or injury. They can work for private companies and government agencies.

Nurse Educator

Nurse educators prepare new nurses to enter the workforce or train experienced nurses in more advanced techniques. This can include teaching classes and providing on-the-job training. They often work for colleges, universities, and large health care providers.

While their duties don’t always include research, nurse educators must keep up with the health care industry’s needs and new patient care practices. This is so they can provide relevant education themselves and help their organizations design up-to-date curricula.

Make Nursing Research a Part of Your Journey

Conducting and implementing nurse research is a collaborative effort. It takes a team of informed leaders, skilled analysts, and creative educators to create effective, evidence-based policies. Those interested in pursuing nurse research should consider The University of Tulsa’s online MSN program , which can prepare you to fill any one of those roles and more.

All of TU’s MSN students take classes on research and evidence-based practices. However, the program’s specialty tracks allow students to take their studies in multiple research-oriented directions. For instance, if you’re interested in collecting and interpreting clinical data, you can choose the Informatics and Analysis track. If you have a passion for public health policy, the Public Health and Global Vision track includes classes on population health and epidemiology.

Delivered in a flexible online format, this program can be a great option for working nurses and nontraditional students alike. To find out more, read about TU’s admission policies and request more information today.

Recommended Readings

A Nurse Educator’s Role in the Future of Nursing

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Gallup, “Record High in U.S. Put Off Medical Care Due to Cost in 2022”

International Journal of Nursing Practice, “Nursing Crisis: Challenges and Opportunities for Our Profession After COVID‐19”

Journal of Pain Symptom Management , “Risk Factors Associated With Chemotherapy-Induced Nausea in the Week Prior to the Next Cycle and Impact of Nausea on Quality of Life Outcomes”

Mayo Clinic, Nursing

National Institute of Nursing Research, Scientific Strategy: NINR’s Research Framework

National Institute of Nursing Research, The National Institute of Nursing Research 2022-2026 Strategic Plan

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University Hospitals

Clinical Research Operations Analyst II (Hybrid)

Position # : 240009JX Position : Clinical Research Operations Analyst II (Hybrid) UH Facility : Cleveland Medical Center Shift : Days Status : Full-time Work Days of Week : M-F

City : Cleveland

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These words are more than just our mission, they embody the opportunities available to the world-class doctors, nurses, health care professionals and support staff who choose to join University Hospitals and Be the Difference.

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JOB DESCRIPTION & QUALIFICATIONS

Description

A Brief Overview

This position provides support to the UH Clinical Research Community and business offices of the Clinical Research Center (CRC) in configuring and monitoring financials in the Clinical Trials Management System (CTMS) Velos eResearch as well as the administrative processes throughout the life cycle of a clinical trial. This role will work closely with Research Finance, Grants Accounting and Grants and Contracts to help facilitate study startup activities leading up to site activation for clinical trials. Following study startup, this role monitors financial activity on studies and provides these teams with guidance on outstanding receivable and invoice follow-up throughout the life of a study. This role will also work with study teams to ensure reimbursable activity in recorded timely.

What You Will Do

  • Study Calendar (Billing Protocol) setup in the CTMS from Medicare Coverage Analysis (MCA) or non-patient care budgets and releasing Calendars in the Epic Research Module
  • Initial milestone configuration to track financial activity from case report form completion and manually invoiced activities
  • Providing guidance and training to CRC business office staff and study teams to ensure timely and accurate data entry
  • Data entry / validation of various study processes
  • Overseeing routine delivery of financial metrics reports to CRC business offices and ensuring action is taken to resolve outstanding receivables
  • Overseeing milestone reconfiguration due to amendments or other identified misconfigurations
  • Overseeing / auditing calendar and milestone configuration for accuracy
  • Overseeing / auditing proper allocation of fees due to CRC core offices.
  • Partner with CRC leadership and study teams to identify studies with high screen failure to enrollment ratios aiming to improve fiscal health of research studies

Additional Responsibilities

  • Performs other duties as assigned.
  • Complies with all policies and standards.
  • For specific duties and responsibilities, refer to documentation provided by the department during orientation.
  • Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
  • Bachelor’s Degree Health Care Administration, Public Health, Business Administration, Accounting or related field (Required)
  • Master’s Degree Health Care Administration, Public Health, Business Administration, Accounting or related field (Preferred)

Work Experience

  • 3+ years Clinical Research Employment (Required)

Knowledge, Skills, & Abilities

  • Advanced Skill in MS Excel (Required proficiency)
  • Experience with Velos eResearch or OnCore is required (Required proficiency)
  • Experience with Epic Research Module and Research Billing Concepts (Required proficiency)
  • Experience with Epic SlicerDicer and Reporting Workbench preferred (Preferred proficiency)
  • Demonstrates ability to read and interpret contract and payment terms (Required proficiency)
  • Demonstrates ability to manage time, prioritize work and independently complete tasks with limited direction (Required proficiency)
  • Strong and clear communication skills (Required proficiency)

Physical Demands

  • Standing Occasionally
  • Walking Occasionally
  • Sitting Constantly
  • Lifting Rarely 20 lbs
  • Carrying Rarely 20 lbs
  • Pushing Rarely 20 lbs
  • Pulling Rarely 20 lbs
  • Climbing Rarely 20 lbs
  • Balancing Rarely
  • Stooping Rarely
  • Kneeling Rarely
  • Crouching Rarely
  • Crawling Rarely
  • Reaching Rarely
  • Handling Occasionally
  • Grasping Occasionally
  • Feeling Rarely
  • Talking Constantly
  • Hearing Constantly
  • Repetitive Motions Frequently
  • Eye/Hand/Foot Coordination Frequently

Travel Requirements

  • 5% Travel to other sites is uncommon, most travel will be between WO Walker Building and UH Cleveland Medical Center Lakeside Building

Working at University Hospitals

UH Cleveland Medical Center

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Working at University Hospitals

Careers at University Hospitals offers opportunities to provide care locally in the Cleveland area with the power to impact healthcare nationwide. As a leader in our industry, our staff share a commitment to Be the Difference in the lives of our patients and our communities, from Northeast Ohio and beyond. Take a look at this video to discover how we’re building an organization for the future, today. Note: video content was obtained prior to the COVID-19 pandemic.

ANEESAH DAVIS: You have a choice to be here or not be here. The choice for me to just actually just stay here is just, I love it. I love it here to be honest and the opportunities that it allowed me to have and grow. That's basically why I choose to stay here. SONORA HOWSON: My favorite part is probably the people I work with. I mean I'm interested in the procedures and I feel like we do a lot of good. But like the thing that has me excited to come back every day is just that I work with such an incredible team. Really talented people and it feels like a family. I know that's like kind of trite to say but it does feel like that. ALVIN MANIGAULT: One of the things I was really impressed with my time being at UH, just from a managerial and leadership perspective, I think they do a phenomenal job. My leadership specifically in terms of just being involved and engaged and also listening as well to matters, issues or concerns and then working to establish some type of implementing change. I think subsequently for me as an employee, it really makes me feel as if I'm heard, my voice is heard and that also my perspective can have an impact on the overall overarching picture as well.

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CTS Frequently Asked Questions

Am i eligible for admission into the cts program.

Eligible individuals are trained in the medical sciences, most commonly fully-trained physicians. Other with similar training are also considered: doctoral degrees in veterinary medicine, dental medicine, or pharmacy; predoctoral students enrolled in medical school (including MD/PhD candidates) or other PhD programs; and students with prior master’s degrees in epidemiology, biostatistics, clinical research, and related fields.

How do I apply for the CTS MS and Certificate Programs?

You must submit your application through the Graduate School of Biomedical Sciences (GSBS) online application system.  Information can be found in the Admissions section of this website. GSBS will process your application and transfer the materials to the CTS Program.

What is the application deadline?

There are three application deadlines for the CTS PhD, MS, and in-person Certificate Programs. 

  • December 1 (Early Notification) 
  • April 1 (Regular Deadline for Students that Require a Visa)
  • May 1 (Regular Deadline for Students that Do Not Require a Visa)

Applications for the HEOR Program are due August 15.

Are GRE scores required?

Applicants to the CTS Program who have previously completed a PhD in a STEM field, or a MD, DO, DDS, DVM, or equivalent, are not required to complete the GRE general test. All other degree holders should take the GRE General Test.

Is the ECFMG certification required?

The ECFMG (Educational Commission for Foreign Medical Graduates) certification is not required for proof of medical and clinical work experience. The most competitive candidates have completed clinical training and work experience in US based medical or health services institutions. The ECFMG Certification is one way to waive the TOEFL/IELTS requirement for non-native English speakers.

Are fellowship and program application dates the same?

Yes. Candidates seeking fellowship support must include this information in their Personal Statements and outline their qualifications for fellowship consideration.

Can I apply before I have finished medical school?

Yes. If you are a medical student and interested in applying to the CTS Program before you complete your MD degree, please contact the CTS Program Director or Manager to discuss your options and your eligibility for a T32 Predoctoral Fellowship.

Can I submit a copy of my transcript?

Please upload a copy of your transcript from each college and/or university you have attended, regardless of whether you earned a degree. Additional information can be found  here .

Do applicants have to come to Boston for interview?

Candidates may be interviewed on site in Boston or via Zoom or telephone.  Candidate interviews generally take place from January to March.

Are there options that do not involve writing a thesis?

Yes our certificate programs do not require a thesis. 

The Clinical & Translational Certificate Program does not require a written thesis. However, a customized approved brief research project, initiated at the beginning of the final semester is a requirement as well as a poster presentation at the annual CTS Graduate Program Symposium which is held each May.

The online HEOR Certificate Program requires coursework only.

Do I have to write a thesis to obtain an MS?

Yes. In order to receive a MS in the CTS Program, all students must undertake independent clinical research and complete an approved final thesis.

How long is the MS program?

The MS degree program is structured as a two-year full-time commitment.  The first year of the program begins in July and continues with a Fall and Spring semester.  In Year Two, there are no summer courses, only Fall and Spring semester courses.

Can I participate in the CTS program without doing a fellowship?

Yes, all interested individuals may apply for admission to the CTS Program.  Students admitted into the Program without fellowship support do not receive stipends and are directly billed for tuition and fees by Tufts University.

Can I take courses without being admitted to the MS program?

Individuals who have not been admitted to a GSBS degree program may take core or elective courses, with approval from the course instructor as a Non-Degree Student.

Can I use NRSA or other student fellowship support as a CTS student?

Yes. Prospective students may apply for a limited number of fellowships with the Tufts Clinical and Translational Science Institute. These highly competitive fellowship include full tuition for study in the MS or PhD CTS Programs as well as annual stipends, and research and travel funds. These fellowships are NIH-funded and can only be held by US citizens or permanent US residents. 

Do I have to be working in a clinical setting to apply?

No. However, the most successful candidates intend to pursue careers as independent investigators in clinical and translational research and are able to demonstrate commitment to this goal in their application.

Do I qualify for a student visa if I am a nonmatriculated student?

No.  Student visa eligibility criteria include full-time enrollment in a degree program.

Are there postdoctoral fellowships in Clinical & Translational Sciences

Yes. Prospective students may apply for a limited number of fellowships with the Institute for Clinical Research and Health Policy Studies (ICRHPS). These highly competitive fellowships include full tuition for master-level study in the CTS Program, annual stipends, research and travel funds. Fellows are assigned ICRHPS office space.  ICRHPS postdoctoral fellowship opportunities vary by candidate eligibility, citizenship, required activities, and stipend amount, but all require full-time enrollment in the CTS Graduate Program.

Does the CTS Program offer online courses?

Some of the courses for the CTS Program have Distance Learning options. The program is not offered as an online only degree program. However, the HEOR Certificate Program is an online program.

If I can't devote two years of study, can I still be a part of the program?

The CTS Program has a Certificate Program that is designed to provide a basic foundation in clinical research for physicians and other doctorally-trained clinicians who are unable to devote two or more years of full-time study to obtain a MS or PhD degree.

COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK

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Clinical Research Manager

  • Herbert Irving Comprehensive Cancer Center
  • Columbia University Medical Center
  • Opening on: Sep 4 2024
  • Job Type: Officer of Administration
  • Bargaining Unit:
  • Regular/Temporary: Regular
  • End Date if Temporary:
  • Hours Per Week: 35
  • Standard Work Schedule:
  • Salary Range: $95,000 - $100,000

Position Summary

The candidate will be an integral member of the senior leadership team within the Clinical Protocol & Data Management (CPDM) Office of the Herbert Irving Comprehensive Cancer Center (HICCC). Responsibilities include but are not limited to: coordinating the data management activities of the CPDM, while providing supervision and delegation of work assignments and evaluation of the CPDM Clinical Research Coordinators (CRCs) and Data Coordinators(DCs); creating and promoting professional development opportunities (both internally and externally) for staff; implementing processes and that improve, streamline, and stimulate the work environment; continually assessing trial complexity/workload and resource allocation to ensure patient safety and clinical research excellence; ensuring and promoting positive relationships and outcomes with private industry and other external agencies. The Clinical Research Manager reports directly to the Assistant Director, Clinical Research Operations.

Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.

Responsibilities

Responsibilities include, but are not limited to:

o Posts/justifies new and replacement positions, screens applicants. o On-boards and trains staff (protocol, university, departmental training). o Liaises with the HICCC HR representative for scheduling medical surveillance, JCAHO, and other HR-related functions. o Makes appropriate salary recommendations for new and existing staff based on prior experience and conducts annual staff performance reviews (including establishing and continually monitoring FY goals).

• SUPERVISION

o Monitors, directs, and supervises staff in a manner that facilitates efficient level of operations. o Determines CRC and DC workloads and protocol assignments. o Assures the subject data collected by the CRCs is organized and submitted in a timely manner. o Develops quality control mechanisms to ensure accurate data reporting. o Assists with CRF development, accuracy, and implementation for investigator initiated trials. o Ensures CRC’s are adequately prepared for and successfully manage all monitoring and/or auditing visits.

• PROTOCOL MANAGEMENT

o Provides protocol management and research expertise by participating in discussions pertinent to projects at collaborative research meetings. o Organizes projects and collaborates with multidisciplinary team and other health care personnel as needed to complete assigned tasks. o Attends regularly scheduled conferences and meetings.

• DEPARTMENT INITIATIVES

o Assists the CPDM Leadership Team in developing, implementing, and executing departmental Standard Operating Procedures (SOPs). o Develops standardized forms, study tools, and promote cross-coverage with CPDM Leadership to ensure coverage, provide appropriate staff updates, in-services, trainings, etc.

• NCI RELATED FUNCTIONS

o Assumes the role of site Clinical Research Associate (CRA) for the National Clinical Trial Network Programs (Alliance, SWOG, other) if assigned this role. o Manages and submits NCI research base membership applications for new investigators and research staff. o Ensures staff access and training on various NCI consortia group systems; obtains CTEP ID’s, establishes roles and privileges, and maintains rosters o Works with the CPDM Compliance Core to create a Q/A oversight plan for internal monitoring of NCI sponsored trials. o Obtains, reviews, disseminates data quality reports to PI’s and research staff, including component sites. Enforces data quality, timely submission, and query resolution.

o Performs other related duties as assigned.

Minimum Qualifications

  • Bachelor’s Degree or equivalent in education, training and experience, plus 4 years of related experience.

Preferred Qualifications

  • Certification as a Clinical Research Professional through a national accrediting body such as ACRP and/or SoCRA.
  • Minimum one year of supervisory experience.
  • Experience in clinical research setting necessary, including a thorough understanding of ICH-GCP and CFR guidelines.
  • Excellent interpersonal and organizational skills.
  • Computer skills, proficiency with MS Office products (Word, Excel, PowerPoint).

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.

Commitment to Diversity 

Columbia university is dedicated to increasing diversity in its workforce, its student body, and its educational programs. achieving continued academic excellence and creating a vibrant university community require nothing less. in fulfilling its mission to advance diversity at the university, columbia seeks to hire, retain, and promote exceptionally talented individuals from diverse backgrounds.  , share this job.

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Why we need a revolution in clinical research.

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Masud Husain, Why we need a revolution in clinical research, Brain , Volume 147, Issue 9, September 2024, Pages 2897–2898, https://doi.org/10.1093/brain/awae265

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We are at a pivotal moment for clinical research. In the UK, the system is fundamentally broken as recent reports have alluded to. 1 , 2 In other parts of the world too there are similar issues that are, at the very least, slowing down innovation and research. There are many factors that have been identified as contributing to this sad state of affairs in the UK. One important issue that has not attracted so much attention recently—though it was the subject of a report 3 in 2020—is the relationship between higher educational institutions (mostly universities) and healthcare providers (largely the National Health Service, NHS).

The vast majority of research activity in the UK occurs within the higher education sector, while most patient-related research such as clinical trials relies on NHS infrastructure. And this is where there is a massive disconnect. Each of these systems are huge, cumbersome behemoths, with their own local lumbering administrations focused on aims that are not aligned to the mission of producing rapid results in clinical research. In the university sector, the priorities of leaders are to keep the system financially afloat and minimize potential legal risks. Many institutions in the UK are on the cusp of fiscal ruin and so require grant and other research income to subsidize their existence. In the NHS on the other hand the aim is to cut waiting lists which, post pandemic and doctors’ industrial action, are now very lengthy, and to provide adequate service delivery. Making healthcare research effective and efficient is the last thing on the minds of the leadership of either sector.

But who can blame them? Surely, it’s difficult enough to run either a university or an NHS hospital? Indeed, this seems sufficient explanation—an adequate excuse—for some leaders of both these types of institution for the huge delays in getting any useful research done. Many teams are now waiting over a year to get their grant-funded research off the ground. Remarkably, some trials are failing because they never start, several years after the funding has been awarded. Material or data transfer agreements between universities; slothful legal reviews of contracts and agreements with third parties; calculating overheads to be charged; multiple reviews of research protocols by R&D departments; dragging of feet over costings independently for the university and hospital; sluggish reviews by research services; signing off contracts with the NHS; obtaining honorary contracts for non-clinical personnel; and many other procedures may take months, if not years, to complete. The system is both Byzantine and exasperating to navigate. No wonder that pharmaceutical companies are balking at initiating trials in the UK, their gaze turning instead to countries where they are more serious about getting things done sooner, not later. 1

So how do we get out of this mess? Given the narrow goals that the leaderships of universities and NHS hospitals have, we cannot expect a great deal more from them on this front— unless they are compelled to make changes. In the UK, when the National Institute for Health and Care Research (NIHR) was formed in 2006, many of us were under the impression that its mission really was to ‘create a health research system in which the NHS supports outstanding individuals, working in world-class facilities, conducting leading-edge research focused on the needs of patients and the public’. 4 Clearly though this just hasn’t happened. Otherwise, why the need for recent reports? 1 , 2

One of the key reasons for this failure (we cannot refer it to it as anything else) is the simple fact that universities and NHS infrastructure are not joined up. Many pretend to be, but it is obvious to anyone who works at even the best centres in the UK that this is a sham. At Oxford, one of the hospital networks calls itself the Oxford University Health NHS Foundation Trust, but there really is very little to suggest why ‘University’ should be in its title. The levels of duplication of work and contracting between the university and the hospital make a mockery of the concept of seamless integration between these institutions. It is the same elsewhere too. The result is a growing duopoly of administrations that negotiate with each other, waste time and slow the pace of progress. Even when a research proposal has been approved by a ‘joint’ R&D unit, there needs to be a costings agreement between university and NHS trust.

From a national perspective this makes little sense, either economically or for governance. We are in the bizarre situation where two sets of institution—universities and hospitals—both largely funded by taxpayers are independently setting their (growing) administrative staffs to scrutinize research protocols or haggle over costings on projects that are mostly funded by government or charities. It is even worse for multicentre studies when many different universities and NHS trusts each want a share of the pie. This has a hidden cost in numbers of people employed, researchers’ time dealing with paperwork, and an opportunity cost in terms of time taken to get studies off the ground. Furthermore, there is no incentive to do things better or faster. There is simply a parochial incentive to make money locally and mitigate risks locally . Until the day that universities and hospitals associated with them are compelled to work as one integrated unit, there is very little hope for change. We will be left in the current quagmire of structural indolence. And that is why we need a revolution. Writing more reports on the matter will not help.

It is interesting to reflect on the fact that it was also radical change that was necessary to bring medicine into the modern era—to make it based on observation, clinical examination and the scientific method—in the first place. From the confusing and sometimes bizarre practices that characterized medicine in the 18th century, there emerged a new way of doing things which came about within one generation and in perhaps one of the least advanced places in Europe for clinical science at that time: Paris. From being a backwater, the ‘Paris School of Medicine’ instigated such dramatic change that within 50 years it became the leading international centre for clinical practice, attracting physicians from around the world to learn about the ‘new medicine’. 5

The rise of scientific medicine in Paris depended on systematic correlation of physical examination findings on hundreds of patients with pathological findings at post-mortem; flexibility to revise diagnoses on the basis of these assessments; deployment of statistics, including data on mortality; and most of all on conducting this work and teaching it to medical students in hospitals. 5 What made this possible was reform. Before the French Revolution, control of medical care rested largely with the Church. With the reform of medical education that came after the Revolution, hospitals were centralized and their administration was overseen by the state. Fundamental changes in the way in which faculties of medicine were organized in France led the way for dramatic new ways of learning from patients and disseminating knowledge to clinicians. Medical education was transformed but it needed the convulsive change of a Revolution to make this happen. 6 It required top-down edicts to bring about change because there was no incentive for the old institutions to make those changes themselves.

We are now confronted with a similar problem. The old institutions—universities and hospitals—are used to doing things their way. There is no incentive for them to change unless the state or its organs of power intervene. In the UK, NIHR funds now support Biomedical Research Centres (BRCs) which supposedly cross universities and NHS hospital trusts, but in truth the fiscal support helps to prop up university research personnel with very little going to the NHS. Most importantly, the NIHR has not insisted on BRCs having joined up (i.e. single) integrated, university-NHS systems in place, or for seamless national transfer of approvals across sites without the need for new sets of contractual agreements. Nothing fundamental will change unless it or the new government compels this change. The pursuit of national interests requires national leadership to intervene; we can't rely on local, devolved institutions to make the obvious decisions that are required. This is why we need a revolution in healthcare research.

O’Shaughnessy J . Commercial clinical trials in the UK: The Lord O’Shaughnessy review - final report. Accessed 13 August 2024. https://www.gov.uk/government/publications/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review-final-report

The Academy of Medical Sciences . Future-proofing UK health research: A people-centred, coordinated approach. https://acmedsci.ac.uk/file-download/23875189

The Academy of Medical Sciences . Transforming health through innovation: integrating the NHS and academia. https://acmedsci.ac.uk/file-download/23932583

Department of Health and Social Care . Best research for best health: a new national health research strategy. https://www.gov.uk/government/publications/best-research-for-best-health-a-new-national-health-research-strategy

La Berge A , Hannaway C . Paris medicine: Perspectives past and present . Clio Med . 1998 ; 50 : 1 – 69 .

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Ackerknecht EH . Medicine at the Paris hospital, 1794–1848 . Johns Hopkins University Press ; 1967 .

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Director, Clinical Trials Implementation & Coordination

  • Madison, Wisconsin
  • SCHOOL OF MEDICINE AND PUBLIC HEALTH/CLINICAL RESEARCH
  • Partially Remote
  • Staff-Full Time
  • Opening at: Sep 5 2024 at 10:55 CDT
  • Closing at: Sep 20 2024 at 23:55 CDT

Job Summary:

UW Clinical Trials Institute is a partnership between the University of Wisconsin School of Medicine and Public Health (SMPH) and UW Health. It supports clinical research professionals, investigators, and participants to advance discovery and research in the prevention, detection, and treatment of disease to help improve the health of individuals, families, and communities across Wisconsin and beyond. Our exceptionally talented and diverse workforce provides care, support, and provide information to clinical trials participants; resources, training, and guidance to research professionals; and opportunities for industry partners to advance groundbreaking medical research. Supporting the mission and vision of the UW CTI, the Director of Clinical Trials Implementation and Coordination will manage clinical trials study activation and coordination across the UW Health and UW-Madison enterprise. They will provide oversight and management to the Portfolio Management Team, providing start-up management, and the clinical research coordinator teams providing study implementation and coordination services across the enterprise. Working directly with investigators and staff, they will ensure the appropriate use of resources, and the management of efficient study work. The Director of Clinical Trials Implementation and Coordination will work with senior leadership on strategy for the research portfolio and will ensure an adequately trained and staffed team to complete required study activities. They will be the primary contact with Principal Investigators (PIs) ensuring that studies are being completed on time and on budget and will work across the organization to mitigate potential compliance or implementation challenges. The Director of Clinical Trials Implementation and Coordination will serve as a content expert resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem solving related to clinical, logistical, financial, and regulatory issues. They will maintain strong collaborative relationships with ancillary services, UW Health Nursing, UW Health Lab and operational staff in the clinics and hospitals in which we work. They will further work to ensure a research culture that encourages compliance, collaboration, efficiency and professionalism among all staff. The incumbent should possess excellent time management skills, ability to work collaboratively, manage multiple projects despite interruptions, while closely tracking details and looking for ways to improve processes, have advanced communication skills, the ability to interface with multiple parties with competing interests, and demonstrated ability to work in multi-disciplinary teams.

Responsibilities:

  • 30% Plans staff implementation of protocols and on-going quality review of one or multiple highly complex clinical research trials or programs
  • 15% Analyzes research portfolios and accounts, solicits internal and external research opportunities, promotes unit capabilities, and makes recommendations to leadership for strategic program enhancements
  • 10% Compiles audits and documents research data to ensure necessary compliance with institutional policies and procedures
  • 20% Exercises supervisory authority, including hiring, transferring, suspending, promoting, managing conduct and performance, discharging, assigning, rewarding, disciplining, and/or approving hours worked of at least 2.0 full-time equivalent (FTE) employees
  • 5% Develops and monitors the program budget; and reviews and approves expenditures
  • 5% Drive and support strategic initiatives under the guidance of senior leadership to advance clinical research programs
  • 10% Provide project consultations, trial updates, and budgetary considerations, while also serving as a liaison to ensure strong internal and external relations
  • 5% Partner with training resources throughout the organization to establish a continuous education framework & training for clinical research coordinator & portfolio manager staff to ensure personnel are up-to-date and skilled

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

Preferred Bachelor's Degree

Qualifications:

Required: - Minimum 1 year of formal supervision of coordinators or project management staff - Minimum 8 years' experience in clinical trials operations with experience that includes regulatory, coordination, project management and budget/contract negotiation. - Working knowledge of Good Clinical Practices (GCP) and current FDA regulations for clinical trials research. - Previous experience with OnCore, eBinders, Electronic Health Records (preferably Epic), and IRB applications - Proven ability to train study coordination staff in efficient and effective clinical trials workflows - Previous experience working with Contract Research Organizations and Industry Study Sponsors Preferred: - Experience with Device research - Clinical Trials Certification, CCRC, CCRA or CCRP

License/Certification:

Required Drivers License - Valid and Meets UW Risk Management Standards Travel is required. Must provide a valid driver's license. Employees may use their own transportation or receive approval for University Car Fleet usage. Employment is conditional pending the results of a Pre-hire Driver Authorization Check. See https://businessservices.wisc.edu/managing-risk/driver-authorization-and-insurance/driver-authorization/#become-authorized-driver (click on 'Become an authorized driver' then click on 'Required criteria').

Full Time: 100% This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.

Appointment Type, Duration:

Ongoing/Renewable

Minimum $116,426 ANNUAL (12 months) Depending on Qualifications The starting salary for the position is $116,426 but is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at ( https://hr.wisc.edu/benefits/). SMPH Academic Staff Benefits flyer: ( https://uwmadison.box.com/s/r50myohfvfd15bqltljn0g4laubuz7t0

Additional Information:

University sponsorship is not available for this position, including transfers of sponsorship. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. UW-Madison is not an E-Verify employer, and therefore, is not eligible to employ F1 STEM OPT Extension participants. If you are selected for this position you must provide proof of work authorization and eligibility to work. This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years.

How to Apply:

To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience, and a document listing contact information for three (3) references, including your current/most recent supervisor. References will not be contacted without prior notice. Your cover letter should address your qualifications as they pertain to the required job qualifications, along with any relevant preferred qualifications and interests and goals.

Rafael Veintimilla [email protected] 608-890-4157 Relay Access (WTRS): 7-1-1. See  RELAY_SERVICE  for further information.

Official Title:

Clinical Research Director(RE017)

Department(s):

A53-MEDICAL SCHOOL/CLINICAL RESEARCH

Employment Class:

Academic Staff-Renewable

Job Number:

The university of wisconsin-madison is an equal opportunity and affirmative action employer..

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  30. Director, Clinical Trials Implementation & Coordination

    Job Summary: UW Clinical Trials Institute is a partnership between the University of Wisconsin School of Medicine and Public Health (SMPH) and UW Health. It supports clinical research professionals, investigators, and participants to advance discovery and research in the prevention, detection, and treatment of disease to help improve the health of individuals, families, and communities across ...