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The Pathway to Becoming a Clinical Research Associate

Introduction to a Clinical Research Associate Career

The role of a clinical research associate, essential skills for a successful cra, certification and education requirements, clinical research coordinators (crc) and clinical trial assistants (ctas), entry-level cra positions, career progression in research, clinical trial project manager (pm) or clinical trial manager (ctm), clinical trial it specialist, conclusion and future trends in cra careers.

The clinical research enterprise supports the discovery of novel therapies, interventions, and diagnostics in many therapeutic areas and applications. Driven by technological enhancements and gains in precision medicine, clinical research professionals are in high demand. Speculative reports indicate the clinical trial market will reach over 70 billion dollars by 2028. [1] With concerns over the anticipated shortages of clinical research associates (CRAs), there are many training options available to choose from.

CRAs can expect to make between 60K and 120K+ per year, depending on a combination of experience, job requirements, location, and education. Individuals may seek employment opportunities from pharmaceutical companies, contract research organizations (CROs), and the federal government. Since they are part of the enterprise of improving patient outcomes, most find their careers in clinical research highly rewarding.

The primary work of a clinical research associate (CRA) consists of monitoring the activities of a clinical research site. Their scope of responsibility also includes facilitating communications between sponsors and research sites, ultimately helping a clinical study reach a successful completion.

A CRA is tasked with overseeing the implementation of a clinical trial protocol in a manner that prioritizes patient safety and data integrity. Specific activities include monitoring:

• Subject recruitment
• Subject screening and enrolment
• Adherence to Good Clinical Practice
• Generation of complete and accurate documentation
• Recording of study data into case report forms and electronic data capture systems
• Study site management

CRAs serve as the nexus among key study stakeholders, such as pharmaceutical companies, principal investigators, clinical research coordinators (CRCs), and clinical data managers. They are core facilitators in the production of the scientific data essential to the development of life-saving diagnostics and therapeutics. [2]

Becoming a successful CRA typically begins with an interest in clinical research. It is common for individuals who enjoy fast-paced work environments, critical thinking, and helping others to choose a research career.

Successful CRAs demonstrate above-average communication, problem-solving, and organization skills. Industry veterans also tend to display a natural tendency towards empathic-based leadership qualities and the ability to work well under pressure.

The CRA is often in charge of multiple study sites. Subsequently, a clinical study professional should be comfortable with travel and demonstrate a high level of computing proficiency to manage substantial amounts of reporting and documentation.

Complementary skillsets that can contribute to the success of a CRA include:

• A comprehensive understanding of activities related to early drug discovery through commercialization
• Advanced medical or scientific knowledge because study data features complex medical terminology, statistical elements, and medical procedures
• Advanced writing abilities to handle the high density of communications
• Well-developed project management skills

Most CRA positions require a bachelor’s degree in life sciences or related fields and a healthy amount of clinical study experience. Several universities offer graduate certificates or master’s degrees in clinical research or clinical trial management. Obtaining a CRA university credential consists of meeting specific eligibility benchmarks determined by educational background, hours of CRA-related experience, letters of recommendation, and industry-specific training records.

Two industry associations offer professional credentials through certification exams. In order to sit for the exam, an aspiring CRA needs to have completed extensive hours working in the field.

The roadmap to obtaining a CRA certification from the dominant professional society mandates the following requirements and benchmarks [3]:

• A minimum of a bachelor’s degree in a life science-related discipline and 3,000 hours of work in human subjects research
• Or an undergraduate or graduate degree (excluding graduate certificates) in the field of clinical research plus 1,500 hours of work in human subjects research
• And an advanced knowledge of applicable regulations, Good Clinical Practice guidelines, and HIPAA requirements

It should be mentioned that professional association credentialing is not necessary to work as a CRA, although some find certification helps obtain employment in certain circumstances.

Career Pathways and Advancement

As with many chosen career paths, the journey to becoming a CRA is not necessarily linear. Many successful CRAs find that training as a CRC allows for greater industry experience and a more fluid transition into a prominent CRA role. A CRC, and sometimes a research nurse, helps conduct a clinical trial and typically works at one site. The transition to a CRA requires a shift in perspective from one who conducts the trial to one who monitors those who conduct trials at several sites.

Alternatively, CRAs may begin their careers as clinical trial assistants (CTAs). CTAs assist with eligibility assessments, personnel management, and participant needs. They also oversee some of the clinical site’s daily functions, which may include correcting safety hazards, maintaining HIPAA and compliance records, and ordering supplies.

Entry-level CRA positions provide a fantastic opportunity to gain more field experience. To help hone their understanding of what is expected, it is common for entry-level CRAs to work alongside other senior members or clinical trial leads.

Hallmarked by extensive administrative and scheduling duties, research data generation and recording, subject recruitment and retention, and determination of study eligibility, entry-level CRAs should learn all the functions that coincide with a clinical trial. Other job functions entail understanding the U.S. Food and Drug Administration’s (FDA) regulatory requirements for clinical research and product market approval.

There are many lucrative management-level opportunities for senior-level CRAs. Most positions require a minimum of a bachelor’s degree. However, some higher-paying jobs may require candidates to have a master’s or doctoral degree, along with a strong record of accomplishment and qualifying experience. CRAs who enjoy mentoring others may also find that exploring training-type positions may provide new opportunities.

Related Career Opportunities in Research

A person in one of these roles is in charge of planning and overseeing the functional details of clinical trials. Working directly for a pharmaceutical company sponsor or CRO, a PM or CTM organizes the personnel, resources, and conduct of research, from initial trial design through study closeout and the final analysis of trial data. The PM or CTM is also responsible for study site management, data capture, analytics, monitoring, validation, and reporting results.

Pivotal to the applications needed to fuel the trend toward decentralized clinical trials, the clinical trial IT specialist is responsible for maintaining the systems used to conduct participant activities and gather study data. This includes optimizing user interfaces for digital functionality and multi-device capabilities. The IT specialist is often responsible for overseeing the integration of electronic data capture systems and maintaining systems used for clinical data analysis. The clinical IT specialist also represents the first line of defense against patient privacy violations, system threats, and HIPAA violations. [4]

Fueled by the need for improved outcomes, we can expect more innovations to emerge from the research sector in the years ahead. There is also a growing momentum to bring more inclusive trial experiences to marginalized populations. Catapulting off an already robust climate, the demand for clinical research professionals will increase significantly. The high demand could dictate the way that the clinical trial industry approaches staffing decisions by hiring based on specific proficiencies.

Current trends hint at a bolder convergence between real-world data and artificial intelligence that may result in improved predictive disease modeling, clinical decisions, and drug optimization. [5] Algorithmic-based capabilities also carry the potential to inform recruitment strategies by removing some of the barriers that impede participation, thereby improving patient diversity.[6] These trends will shape the future of CRA work, thereby demanding that CRAs stay abreast of changes in how clinical trials are designed and implemented.

With so many revolutionary changes to the medical and clinical trial landscape, there has never been a more exciting time to join the research community. Learn more about CRA opportunities today.

1. Markets and Markets Clinical Statistics. Clinical Trials Market Statistics . Accessed June 17, 2024

2. Kandi, V., & Vadakedath, S. (2023). Clinical Trials and Clinical Research: A Comprehensive Review . Cureus, 15(2).

3. Association of Clinical Research Professionals. “ ACRP-CP Certification .” Accessed June 17, 2024.

4. He Y, Aliyu A, Evans M, Luo C. Health Care Cybersecurity Challenges and Solutions Under the Climate of COVID-19: Scoping Review . J Med Internet Res. 2021 Apr 20;23(4): e21747.

5. Harrer, Pratik Shah, Bhavna Antony, and Jianying Hu. Artificial Intelligence for Clinical Trial Design . Trends in Pharmacological Sciences 40(8):577-591. Accessed June 17, 2024

6. Kurt, A., Semler, L., Meyers, M. et al. Research Professionals’ Perspectives, Barriers, and Recommendations Regarding Minority Participation in Clinical Trials . J. Racial and Ethnic Health Disparities 4, 1166–1174 (2017)

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How To Become A Clinical Research Associate - A New Scientist Careers Guide

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What does a clinical research associate do?

Clinical research associates (CRAs) are responsible for running clinical research, which consists of trials designed to test new or current drugs/immunisations and analyse their effectiveness, risks, benefits and safety of use. 

CRAs play an important role in the healthcare industry and public health development by helping to design and test new medications, vaccinations and other therapeutic agents.

CRAs can be involved at any stage of a drug development trial, including planning, coordinating and supervising. It is their responsibility to ensure a drug has been appropriately examined and all its risks have been evaluated before it is released to be used publicly.

CRAs most commonly work for pharmaceutical companies or contract research organisations. They might also have to spend some time working in a hospital setting to collect data about the drugs they are analysing. They might also work for universities or public/global health organisations. 

As a CRA, you may have a range of responsibilities depending on your employer, project and level of experience. Typically, CRAs will need to complete tasks such as:

• Designing and writing trial protocols and standard operating procedures
• Presenting protocols and procedures to steering committees
• Designing data collection forms
• Requesting ethics approvals and working with ethics committees
• Liaising with staff conducting the trials, such as doctors or consultants
• Training local staff based on trial-specific standards
• Monitoring operations during clinical trial data collection
• Collecting completed data collection forms
• Performing data management and analysis, and discussing the results
• Closing trials and finalising reports with the help of a statistician

CRAs will work in a team of other research professionals, including contract organisation or sponsor staff, principal investigators and clinical research coordinators.

How to become a clinical research associate

To become a CRA, you need to obtain a degree in medical sciences, life sciences or nursing. This can be in subjects such as biomedical science , anatomy, physiology, immunology , pharmacology or broader degree subjects like chemistry and biology .

Alternatively, you can access a career as a CRA by acquiring a higher national diploma (HND). This is a qualification equivalent to the second year of a bachelor’s degree. HNDs can be beneficial to those who want to enter more practical fields, clinical research included.

Occasionally, you can enter a CRA role from an administrative background. For instance, if you begin working as a clinical trials administrator/assistant and decide you would prefer the role of a CRA, you can complete additional qualifications to do this. However, this will take some time and can be difficult.

Most employees view undergraduate qualifications as sufficient, but in some cases a postgraduate degree may be beneficial. Master’s degrees and PhDs can gain you an advantage when applying for competitive positions, and help you gain more experience in research .

Work experience is key to securing a clinical research job. You can get this at any point in your training, and some universities may help with this. The types of work experience most useful for a CRA role include:

• Academic research
• Pharmaceutical research (e.g. via a pharmaceutical industry placement during your degree)
• Laboratory work
• Nursing or care work
• Work in a pharmacy or medical sales
• Other, similar activities

How long does it take to become a clinical research associate?

Becoming a CRA will usually take around three to four years, depending on the access pathway you choose.

If you opt to complete an undergraduate degree, this can take three to four years. You can then apply to job positions as a CRA straight away. However, if you don’t have sufficient work experience, you may need to start at a lower-level position such as a more administrative job. From here, you can gain more experience and reapply for a higher-level position.

If you choose to obtain a HND qualification, this will take two years. Provided you have sufficient experience, you can then apply for a graduate post as a CRA, but again you may need to gain some extra experience/qualifications in some cases.

If you opt to do a postgraduate degree first, this may take an additional one to three years depending on whether it is a master’s degree or a PhD. Many CRA job positions also allow for completion of postgraduate qualifications alongside the job.

A day in the life of a clinical research associate

Most CRAs work about 40 hours a week, during weekdays. There may be an out-of-hours commitment, for instance if working in a hospital setting monitoring a new drug, but this is dependent on your employer and role.

CRAs can work on multiple trials at a time, in multiple different sites. This will depend on the complexity of each trial and what stage each of the trials is in. Therefore, the role may entail some travelling at times, while other times most of your work will be concentrated on one site.

As a CRA, you will carry out a wide variety of tasks. Some days may be spent writing reports. On other days, you will work on site with healthcare staff , or you might go into your office and attend meetings.

No matter your experience level or how senior your role is, as a CRA, you will need to work in a team with other research and healthcare professionals. You will be communicating with research nurses, doctors, health consultants, investigators and managerial and administrative staff from the company requesting the trial.

The role requires good communication skills, as well as good time management and organisation skills, because carrying out a few different studies at once may mean some tasks clash with one another and you need to prioritise the most important ones.

Clinical research associate: Career options

As with most clinical roles, CRAs undergo lots of continuing professional development (CPD) within their role. There are many training courses available to CRAs to build on their existing skills and develop new competencies.

Most training courses are organised by external bodies, and many are paid for by the employer. One of the organisations that runs training courses is the Institute of Clinical Research (ICR). It provides training in areas such as effective project management for clinical trials and advanced clinical trial monitoring, among several others.

The ICR also offers certificates and a diploma that you can complete to evidence your skills in clinical research. Becoming an ICR member and obtaining courses and qualifications from it can also be beneficial to career development, as you will meet other prominent professionals in your field through interacting with this organisation.

You can also opt to complete a postgraduate qualification, such as a PhD or master’s degree in several different areas, including clinical research and clinical pharmacology .

As mentioned, you may need to climb up the professional ladder to become a CRA, and many people start off as clinical trial administrators or junior CRAs. Within these roles, you might complete tasks such as handling documentation and correspondence or helping to set up trial sites. 

From here, you can move on to becoming a senior CRA as you gain experience. At this point, you will have more advanced responsibilities, such as project management of whole trials and designing case report forms.

If you develop sufficient experience and gain contacts in the field, there is a possibility of self-employment if you want to become a freelance CRA. 

Salary: How much does a clinical research associate earn in the UK and US?

In the UK, starting salaries for CRAs range between £26,000 and £34,000 per year. As a more senior CRA, you might earn between £35,000 and £50,000, and in the most senior positions involving managerial tasks, you might earn upwards of £55,000.

Salaries will vary between regions and employers, as well as depending on your level of experience and responsibilities. Some companies offer additional benefits.

In the US, the average salary for a CRA is $70,000 per year. The range is between $60,200 and $80,900. This can vary depending on the region you work in, your education and experience levels and any additional qualifications you have.

Salaries will also be different as a freelance CRA, and this will depend on the number of clients you have and any business-related expenses you need to cover.

• Prospects. Clinical research associate. Available from: https://www.prospects.ac.uk/job-profiles/clinical-research-associate (accessed Apr 2024)
• CK Group. Clinical research associate (CRA) job profile. Available from: https://ckgroup.co.uk/candidate/job-profiles/clinical-research-associate-cra-job-profile/ (accessed Apr 2024)
• Nikolova, T. The CRA Wizard. How to become a CRA for dummies in 7 steps (or less). Available from: https://www.thecrawizard.com/how-to-become-a-cra-for-dummies (accessed Apr 2024)
• Glassdoor. Clinical research associate career. Available from: https://www.glassdoor.co.uk/Career/how-to-become-clinical-research-associate_KO14,41.htm (accessed Apr 2024)
• Coursera. How to become a clinical research associate. Published Nov 2023. Available from: https://www.coursera.org/articles/clinical-research-associate
• Walters, L. Pharmiweb.jobs. 8 ways to advance your career as a clinical research associate (CRA). Published Sept 2023. Available from: https://www.pharmiweb.jobs/article/8-ways-to-advance-your-career-as-a-clinical-research-associate-cra- (accessed Apr 2024)
• Salary.com. Clinical research assistant salary in the United States. Available from: https://www.salary.com/research/salary/alternate/clinical-research-assistant-salary (available from Apr 2024)

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ACRP Certification

With a 30-year legacy, acrp certification is the most reputable credentialing program in clinical research. since 1992, more than 40,000 professionals and their employers have come to trust acrp certification as the mark of excellence in clinical research., “joining acrp and becoming certified was the best thing i ever did to jumpstart my career in research and has opened many doors for me.”, jeri burr, ms, rn, ped-bc, ccra, facrp acrp certified since 1999, benefits of certification >, start your next career journey by exploring acrp’s flagship certification and subspecialty credential programs below. each program provides specific information and resources on exam eligibility, exam content, how to apply, scheduling & testing, how to prepare, and after your test. if you have questions, explore the faq page or the acrp certification handbook ., acrp certified professional, acrp-cp ® is a credential formally recognizing clinical research professionals of all types, regardless of their roles or functional activities on the clinical study team., learn more >, certified clinical research associate, ccra ® is a credential formally recognizing clinical research professionals with experience monitoring and supervising the conduct and progress of clinical trials on behalf of a sponsor., certified clinical research coordinator, ccrc ® is a credential formally recognizing clinical research professionals with experience coordinating and facilitating clinical trial activities in adherence to gcp, under the direction of a principal investigator., certified principal investigator, cpi ® is a credential formally recognizing clinical research professionals with experience as a principal investigator or sub investigator on multiple studies., acrp medical device professional, acrp-mdp ® is a credential formally recognizing clinical research professionals with specialized knowledge in medical device clinical trials. candidates must be acrp certified to sit for this exam., acrp project manager, acrp-pm ® is a credential formally recognizing clinical research professionals with specialized knowledge in project management. candidates must be acrp certified to sit for this exam., the academy’s acrp-cp, ccrc, ccra, and cpi programs are accredited by the  national commission for certifying agencies (ncca),  which sets internationally recognized standards for the development and operation of certification programs. the standards assure that a program is valid, reflects current practice, and treats candidates fairly and are based on the established processes for developing certification exams., the most respected certification thought leaders in the country agree that ncca accreditation is the gold standard when it comes to accreditation of programs that certify professionals working in healthcare—including the clinical research industry. when you’re searching for certification programs, make sure you always look for the ncca-accredited program seal., bring certification to your team —acrp certification is an ideal solution for managers looking to enhance team knowledge, grow leaders, and signify to others that their study teams are among the best of the best. learn more >.

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Scientists, researchers, and doctors make discoveries about drugs, surgical procedures, behavioral therapies, or medical devices through their work in laboratories and healthcare settings. This is only the beginning of the journey for pharmaceuticals, therapies, and devices, as bringing the findings from the lab to the street requires a vigorous scientific process known as a clinical trial. Clinical research associates (CRAs) are the professionals responsible for ensuring that clinical trials move forward following established guidelines and regulations for ethics, safety, and reporting.

Clinical research associates, also known as “monitors,” work on behalf of sponsors funding clinical trials for the new or existing drug, device, surgery, or behavioral intervention. Working directly for the sponsor or through a contract research organization, the main task of a CRA is to monitor the progress of an ongoing clinical trial.

Through in-person site visits or remote monitoring systems, a CRA serves as the central point of contact between a sponsor and testing sites; ensures that the trial is being administered per approved protocols; verifies that the clinical trial is being conducted ethically at all sites; and confirms the validity and accuracy of all data being collected and reported at test sites.

In addition to reading, interpreting, and understanding medical technology, clinical research associates must have excellent interpersonal and communication skills. The ability to understand best clinical practices, design protocols, and data standards requires CRAs to have outstanding attention to detail, analytical skills, and the capacity to deliver constructive feedback to participating research sites on their performance.

Although not a requirement, many CRAs travel between multiple research sites for study oversight, which may require a valid driver’s license, the physical capacity to travel, and/or willingness to fly or drive regularly.

This detailed guide explores the education and credentials required to become a clinical research associate (CRA).

Arizona State University

Johns hopkins university (aap), university of west florida, steps to become a clinical research associate (cra).

The pathways to becoming a clinical research associate are numerous and available to anyone with a high school diploma or higher. While formal education is not technically required to enter the field, having a bachelor’s degree or higher can make potential candidates much more competitive.

Certification in the field is also not required, but obtaining certification from the Society of Clinical Research Associates (SOCRA) or the Association of Clinical Research Professionals (ACRP) can result in more opportunities and even more competitive salaries.

Finally, all aspiring CRAs are advised to check out the International Conference on Harmonisation’s (ICH) guidelines for Good Clinical Practice (GCP) to get a feel for the professional expectations and responsibilities.

Here is how to become a CRA depending on one’s level of education. Please note that in the United States, there are two major certification bodies for CRAs: the Society of Clinical Research Associates (SOCRA) and the Association of Clinical Research Professionals (ACRP). Each pathway includes the eligibility requirements to pursue credentialing through either of these entities.

PATH 1: Earn a High School Diploma and Gain Experience

Perhaps the most strenuous route to this career is becoming a certified CRA with a high school diploma and between 3,000 and 3,500 hours of qualifying work experience (depending on the certification entity).

These candidates often start out in support positions assisting a more experienced or certified CRA with mundane tasks. An entry-level worker can earn increased responsibilities through a demonstrated capacity to learn the regulations, protocols, and ethical considerations. To qualify for the following CRA certification exams, high school graduates must:

SOCRA Category 1

• Complete two full-time years of CRA work within five years, or 3,500 hours of part-time work

ACRP CCRA (Certified Clinical Research Associate)

• Complete 3,000 hours performing essential duties
• Submit a resume documenting and demonstrating job performance

Please note that in some cases, additional education can be used to substitute for work experience hours. Please see credentialing websites for details.

PATH 2: Earn an Associate Degree and Gain Experience

Depending on the program, an associate’s degree of applied science (AAS) in clinical research can be a standalone degree or a stepping-stone to a bachelor’s or master’s. Licensed vocational or practical nurse (LVN or LPN) programs are designed specifically for practical, job-ready skills and may qualify aspiring CRAs for the ACRP certification.

Similar to the path taken by those with a high school diploma, having an associate degree, LPN, or LVN can open the door to some entry-level jobs in the industry. At this level, some prospective CRAs assist more experienced CRAs or some engage independently in entry-level tasks related to study monitoring. Those working as CRAs with an associate’s degree, LPN, or LVN can qualify for certification after working a certain number of hours in the field.

To qualify for the following CRA certification exams, associate degree graduates must:

SOCRA Category 2

• Hold a “clinical research” degree
• Complete one full-time year as a CRA or 1,750 hours part-time

ACRP Option 2 (Also for LVN, LPN)

• Hold a “clinical research degree” or complete 1,500 hours performing essential duties

PATH 3: Earn a Bachelor’s Degree and Gain Experience

Most entry-level clinical research associate positions require candidates to have a bachelor’s of science (BS) in a health-related field from an accredited four-year university. In some cases, programs are designed to add practical hours needed to qualify for certification tests.

Those interested in becoming a CRA can study nursing, health sciences, biological sciences, clinical research, clinical research administration, clinical research management, medical technology, or life sciences, among many other subjects. Because many entry-level positions are looking for those with previous work in the field, those earning a BS should seek internships, part-time work, and/or fellowships involving participation in research, if possible.

To qualify for the following CRA certification exams, bachelor’s degree graduates must:

SOCRA Category 3

• Hold a “clinical research” undergraduate degree

ACRP Options 1 & 2

• Complete 3,000 hours performing essential job duties or 1,500 hours of equivalent work experience requirements through ACRP certifications or approved clinical research degree programs accredited by the Council for Higher Education

PATH 4: Earn a Master’s Degree for Opportunities in Management

A master’s program in clinical research is generally designed for those already working as CRAs to expand their skills or to advance into management or supervisory roles within the field. However, for those with non-health science bachelor’s degrees who want to become CRAs, seeking a master’s of science in clinical research or a master’s of science in clinical research management could be a pathway to breaking into the field.

Because many of these programs are offered online, earning a degree is possible for even those students who need full flexibility of schedule to complete the degree. Although requirements for admission into master’s programs vary, those looking to gain admission into a master’s of science for clinical research commonly need the following:

• A bachelor’s degree
• Official transcripts demonstrating specific coursework in science
• A statement of purpose
• Letters of Recommendation or Reference
• A resume or CV
• An application fee
• TOEFL or IELTS scores (international students only)

Clinical Research Associate (CRA) Degree Programs

There is a range of formalized training programs that prepare professionals for this key role in ensuring the safe, and ethical development of medical technologies. Below you will find examples of programs at a range of educational levels available to those interested in a career as a CRA.

Durham Tech – AAS Program

Durham tech, located in Durham, North Carolina, offers a 71-credit hybrid on-campus and online clinical trials research associate (CTRA) associate of applied science (AAS) program. Durham’s CTRA AAS prepares graduates to work on any side of clinical research in an assistant’s role.

While most programs require the student to attend on-campus courses, there are several courses that are offered completely online. The program takes 20 to 21 months and includes coursework in research site management; clinical research management; research protocol design; an introduction to ethics; anatomy and physiology; an introduction to clinical data; pathophysiology; and clinical research terminology.

Graduates of the program may be eligible to sit for national certification examinations and will be prepared for opportunities at medical centers, pharmaceutical industries, hospitals, research facilities, clinics, physicians’ offices, and device companies.

• Location: Durham, NC
• Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC); Commission on Accreditation of Allied Health Education Programs (CAAHEP)
• Expected Time to Completion: 20 to 21 months
• Estimated Tuition: $5,396

Washington University in St.Louis University College – BS, MS, Certificates

Washington University in St. Louis, Missouri, has various degree options for CRAs at all stages of their career to work as monitors. Students can enhance their current skills and knowledge in clinical research management, as well as gain a deep mastery regarding how to best move clinical research forward in an ethical, compliant, and safe way.

Those with at least six units of transferable coursework qualify to apply to the 120-credit-hour bachelor of science in clinical research management to start their careers. Anyone with any educational background can pursue University College’s 21-credit undergraduate certificate in clinical research management to enhance career skills or make a resume more competitive.

Students who already have a BA or BS also have options at Washington University. Experienced professionals in the clinical research field who wish to seek formalized training can earn a 21-credit advanced certificate in clinical research management or a 30-credit master of science (MS) in clinical research management. Those with a non-healthcare bachelor’s degree who wish to become high-level CRAs can up their skills and knowledge by choosing the combined bachelor’s and master’s degree options.

Although the coursework in each program varies to suit the level of education, themes across all the programs include the fundamentals of clinical research management; research ethics and regulatory affairs; compliance, legal and regulatory issues; and data and information management in health sciences.

• Location: St. Louis, MO
• Accreditation: Higher Learning Commission (HLC)
• Expected Time to Completion: BS (up to 48 months); certificate (12 months); MS (24 months)
• Estimated Tuition: Undergraduate courses ($695 to 895 per credit); Graduate courses ($665 to 995 per credit)

Barnett International – Online Seminar

Designed for CRAs with two years of experience or less, this online clinical research associate onboarding program by Barnett International prepares entry-level employees to monitor clinical trials at high levels appropriate to industry standards.

Over ten weeks of synchronous online coursework lasting three hours per week, participants will learn topics including informed consent, investigational product accountability, safety definitions and reporting requirements, and regulatory compliance and quality assurance: audits and inspections. Participants receive 30 hours (3.0 CEUs) of continuing education credits.

• Location: Needham, MA
• Accreditation: Accreditation Council for Pharmacy Education
• Expected Time to Completion: Ten weeks
• Estimated Tuition: By Early Bird Deadline ($1,795); After Early Bird Deadline ($1,995); June 10 is the early bird deadline

Continuing Education for Clinical Research Associates (CRAs)

Both CRA certification bodies require continuing education to maintain active certification status.

SOCRA requires recertification every three years. It calls for 45 hours of CE to be completed over the course of the first three years beyond passing the initial test. Twenty-two CE units must be related to clinical research; the remainder can be in the professional or therapeutic area in which one works or specializes. In addition, those looking to maintain or renew certification must complete a “recertification continuing competence learning module.”

The ACRP expects certified CRAs to engage in continuing education (CE) and continuing involvement (CI) to maintain certifications. Continuing education should include coursework in research and healthcare, and continuing involvement requires candidates to engage in activities such as authorship, participating in investigator meetings, or working as a peer reviewer, among other opportunities. Notably, ACRP utilizes an ongoing point system for professionals to maintain their certifications.

CRA Career and Salary

Clinical trials and the objectivity they bring to advances in treatment are extremely important. In an increasingly globalized society, diseases spread across borders, and in an age of increased antibiotic resistance, new ways to fight bacteria will be needed. Furthermore, with an aging U.S. population comes increased rates of chronic conditions and the subsequent reliance on pharmaceuticals to improve people’s quality of life.

It’s not surprising that the Bureau of Labor Statistics (2022) predicted a 7 percent increase in openings for medical and clinical laboratory technicians between 2021 and 2031, much more than the average growth anticipated across all U.S. occupations during that same decade (5 percent). As far as the salaries are concerned, here are the salary percentiles for clinical laboratory technologists and technicians in the US ( BLS May 2022):

Lastly, while the BLS doesn’t track salaries for CRAs, PayScale.com (June 2023)—a site that relies on self-reported data—found that the median annual salary for a CRA was $72,393. Among the 1,391 CRAs reporting their annual salaries, Payscale found these percentiles:

• 10th percentile: $48,000
• 50th percentile (median): $72,393
• 90th percentile: $101,000

Specialized skills in CRA that increased salaries included medical devices (37 percent pay increase over average), team leadership (35 percent), and writing procedures & documentation (20 percent).

Years of experience, predictably, also have an impact on salary. Entry-level CRAs earn 15 percent below the average, while experienced CRAs (ten to 19 years) earn 16 percent above the average and late-career CRAs (20+ years) earn 25 percent above the average.

It is important to note that these figures also vary based on the data source. For illustration, Indeed.com (June 2023) found an average annual salary of $80,957 among United States clinical research associates.

Becca Brewer is building a better future on a thriving earth by healing herself into wholeness, divesting from separation, and walking the path of the loving heart. Previously to her journey as an adventurer for a just, meaningful, and regenerative world, Becca was a formally trained sexuality educator with a master of education.

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10-Week Clinical Research Associate (CRA) On-Boarding Program

Upcoming Courses

Friday Mornings. No class September 20.

Resume support is available as an add-on option! Click here for more details.

Friday Afternoons. No class December 27, January 3.

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Course Description

This newly updated online 10-Week program provides practical, hands-on training as it relates to the CRA job function, and covers core sponsor and research site activities that promote the successful monitoring of studies for drug, biologic, and device trials. The course is built on Barnett’s deep in-person CRA training experience and is designed to engage participants actively, making the learning experience truly dynamic. Here’s what participants can expect from this revamped, highly interactive training program:

• Enhanced Skills Development: Good Clinical Practice (GCP) skills are reinforced through a combination of activities, including lecture, case studies, in class breakout sessions, interactive web-based knowledge applications, information and support.
• Experts in the Field: Instructor-led weekly classes by an experienced subject matter expert who is passionate about creating interactive learning environments, ensuring participants get the most out of every session.
• Technology Integration: Delivered through Barnett’s Learning Management System (LMS) this course leverages cutting-edge technology to facilitate an interactive learning experience, making complex concepts easier to grasp.
• Application-based Homework Assignments and Final Project: Designed to help gauge progress and allow participants to apply their knowledge in a practical context, fostering a deeper understanding of the material.

The course is designed for “on-boarding” of individual new hires or entire teams. If you are a CRA manager or human resources professional responsible for the orientation and training of one new CRA or 100, this course provides a convenient, cost-effective, comprehensive, and interactive training method. You’ll have peace of mind knowing that you are training your new hires to the highest industry standards.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives

• Describe the application and intention of GCPs
• Differentiate the roles of the Sponsor and Investigator
• Review the drug and device development process
• Discuss the roles and responsibilities of a CRA within clinical research drug and device trials in relation to other roles within an organization
• Discuss protocol design and areas of protocol focus for CRAs
• Discuss the role of Institutional Review Boards (IRBs)/Ethics Committees (ECs)
• Evaluate the Informed Consent Document, process, and monitoring expectations
• Review key essential documents and the CRAs responsibilities in reviewing the Site Master File (SMF) and document collection
• Apply skills in monitoring essential documents and Investigational Product Accountability
• Define Adverse Event monitoring expectations and reporting
• Identify and apply requirements for types of monitoring visits (qualification, initiation, routine monitoring, remote monitoring, closeout visits)
• Discuss key CRA responsibilities during monitoring visits (on-site and remote) including source document verification and source document review
• Apply monitoring skills
• Discuss writing monitoring reports, queries, and visit follow up expectations
• Discuss elements of a study audit, preparation, and common findings

Course Outline

• Module 1: Applications of GCPs in Drug and Device Development Process and Sponsor and Investigator Responsibilities
• Module 2: Drug and Device Development, Roles and Responsibilities of CRAs, and Navigating Protocols
• Module 3: Role of IRBs/ECs and Informed Consents
• Module 4: Essential Documents and Investigational Product Accountability
• Module 5:Safety Definitions and Reporting Requirements
• Module 6: Monitoring Visit Types and Monitoring Expectations
• Module 7: Source Document Verification
• Module 8: Monitoring Visit Reports, Follow-Up Letters, and Contact Reports
• Module 9: Regulatory Compliance and Quality Assurance: Audits and Inspections
• Module 10: Final Project and Course Review

Who Should Attend

• CRAs with less than two years of experience – in-house or remote
• Those currently working in the industry in a different role seeking to change roles
• The course is also ideal for “on-boarding” of individual new hires or entire teams (individual registrations required)

NOTE: This course is for individual registrants only and does not allow for group training.

What previous students have said ...

“The CRA course increased my awareness of the importance of developing strategies and risk-based approaches to monitoring. The breadth of knowledge and experience of the trainers was impressive. The overview of quality systems and regulatory expectations will surely have a place in my daily monitoring activities.”

“This program opened the door for me to really understand what a CRA does and how to document everything. It gave me a true guideline as I manage expectations of all parties and what to look out for during visits, as well as how to document findings in a responsible, accurate way. Thank you so much.”

“I have been given a solid framework on how to approach future studies from site selection, protocol development, and inclusion/exclusion importance to regulatory considerations (when to report what to whom). I plan to make use of all the monitoring tools provided to achieve success and utilize EDC for ease of CRF collection. When in doubt, I will always refer back to modules for guidance. Great course, thanks!”

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Sonja Cooper, Ph.D, M.B.A.

Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies

Course Length and Time

10 weeks for 3 hours each week.

Registration Fees

$1,795 by Early Bird Deadline

$1,995 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 30 hours (3.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-003-L99-P. Released: 3/23.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.

Society of Clinical Research Associates

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Featured Courses

Fda clinical trial requirements regulations, compliance and gcp conference.

New Orleans, LA November 6 & 7, 2024

Dallas, TX March 19 & 20, 2025

This two-day conference is intended to share information among FDA representatives and the regulated community, to facilitate the understanding of regulations, guidelines and practices, and to suggest methods and opportunities to enhance the research professional’s product development experience. The program will focus on the relationships among the FDA and clinical trial staff, investigators and IRBs.

Quality Management Conference

Chicago, IL October 24 & 25, 2024

This conference provides attendees with new information, tools, and real life examples to help participants navigate the components of quality management in clinical research - quality planning, quality control, quality assurance, and quality improvement.

Belonging to SOCRA provides you with the information and resources you need to advance your career and enhance your professionalism.

• 15,100+ Members
• 11,300+ "CCRP" Certified Clinical Research Professionals
• 34 education programs held in 2022

Learn More About Membership

Recent Blogs

Creating a professional workplace.

Extensive research has been conducted on professionalism, including the Center for Professional Excellence Survey, which began in 2009. The Center... Read More >>

What it Means to Be a SOCRA Member

SOCRA membership signifies a commitment to excellence in clinical research. We unite a global community of over 15,000 members across... Read More >>

Workforce Development Transformation and Implementation: The Critical Role of Leaders in Success

Identifying the steps and processes for staff development requires examination throughout the organization. Specifically, developing staff performance standards for every... Read More >>

Our Mission

In order to promote quality clinical research, to protect the welfare of research participants, and improve global health, SOCRA's mission is:

To establish educational programming and provide continuing education for clinical research professionals To establish an internationally recognized certification program for clinical research professionals (CCRP®) To foster the professional development and peer recognition of clinical research professionals

SOCRA's Vision That all clinical research fully protects every research participant and is accomplished with excellence, quality, and professionalism.

33RD ANNUAL CONFERENCE

ACHIEVING EXCELLENCE IN CLINICAL RESEARCH :

FORGING STRATEGIC COLLABORATIONS

September 27 to 29

COUNTDOWN TO EARLY BIRD REGISTRATIONS

Join us for expert-led sessions, interactive workshops, a peer-driven poster program, an engaging exhibit program and unparalleled networking opportunities!

Clinical Research Certification

Clinical research training.

Our clinical research training program s have supported over 22,000 members in the past 7 years. CCRPS clinical research courses   are used by students at 1,200+ organizations, 6 governmental agenies, and 308 universities. Graduates of our clinical research certification have worked at over 1,600 different organizations including all major known CROs and 23% of our graduates have obtained managerial or higher level roles (2024 CCRPS LinkedIn Graduate Survey).  We offer personalized  clinical research career coaching  after clinical research course completion.  See April 2024 Graduate Case Studies .  

We have major clinical research training accreditations including Transcelerate Biopharma, ACCRE, and offer CME for physicians, nurses, and pharmacists through AMA, ANCC, and ACPE.  We are a candidate to become a federally-qualified institution with MSA-CESS. 

We are dedicated to our evidence-based and practice-based education philosophy to help you  learn clinical research  through simply great content unlike what you may have seen before. Clinical research training is self-paced, online, on-demand so you can start today and finish on the go with our mobile app. Speak to our 24/7 chat team or book with a course advisor to see which path is best for you. 

Speak to Course and Career Adviser Liz 

CCRPS Course Catalog

Advanced Clinical Research Coordinator Certification (ACRCC)

Advanced Clinical Research Coordinator Certification (ACRCC) - Triple-Accredited I 200 Hours I Online I Instant Enrollment I Dual ICH GCP w/ E6 and Advanced CRC Certification I 1+ Week Certification I Tuition with 2-4 Month Payment Plans

Advanced Clinical Research Associate Certification (ACRAC)

A Clinical Research Associate (CRA) assists in the monitoring and compliance of clinical trials. Clinical research associate certification is the leading, accredited, internationally-recognized CRA certification program available online.

Advanced International Pharmacovigilance and Argus Safety Certification (APVASC)

Pharmacovigilance Certification - Advanced Pharmacovigilance & Argus Safety Certification (APVASC) ACCRE Accredited I 180 Hours I Online I Instant Enrollment I I I Globally Recognized I 1 Wk Certification

Advanced ICH GCP Certification (AGCPC)

ICH GCP Certification - The most advanced ICH GCP training available I 50 Hours I On-Demand I Biopharma Recognized I 15+ Modules I Instant Enrollment I 1+ Day Certification I

Advanced Clinical Trial Assistant Certification (ACTAC)

Advanced Clinical Trials Assistant Certification (ACTAC) I Industry-Recognized CTA Training I 100 Hours I On-Demand I Accredited I 25+ Modules I GCP & E6 R2 Complaint I Instant Enrollment I 1+Wk Certification I

Advanced Clinical Research Project Manager Certification (ACRPMC)

Advanced Clinical Research Project Manager Certification provides 150 hours of advanced clinical trials and project management training for clinical research professionals looking to get into managerial roles in the industry.

Advanced Principal Investigator Physician Certification (APIPC)

Industry-Recognized PI Training I Modifiable courses based on prior experience I On-Demand I 17.5 CME I 100+ Modules (only review those you don't know) I GCP Complaint I Instant Enrollment I 1D-2 Wks for Certification

Advanced Physician Medical Monitor Certification (APMMC)

Advanced Physician Medical Monitor Certification (APMMC) Triple-Accredited I Written by Physicians I 17.5 CME AMA/ACCME I 250 Hours I 100+ Modules I GCP Complaint I Instant Enrollment I 2+Wk Certification I

CCRPS Clinical Research Community

CCRPS Reviews

CCRPS Graduate Case Studies April 2024

We’re thrilled to share more graduate case studies from graduates of our program. We value full transparency so full case study transcripts and videos will be available at your request. Please email our case study interviewer Courtney Fulkerson, a clinical research project manager herself, at [email protected] if you have any questions about this process.   

Need help deciding on a course or motivating yourself to finish your current course? We want to help you succeed. Speak with our course advisor in clinical research field herself, Liz. Schedule course and career advising session today (email [email protected] your resume before meeting). 

1. From IMG to Clinical Research Coordinator at Columbia University: “ This course not only met but exceeded my expectations with its thorough curriculum and insightful modules.” -Lisa-Pierre ( view full case study )

2. From IMG to Clinical Research Coordinator “The hands-on activities integrated throughout the course really helped solidify my understanding of complex concepts.” - Unber Mahmood ( case study summary )

3. Promoted to Senior Startup Specialist in Clinical Trials : “I appreciate how the course was structured—very interactive and engaging from start to finish.” - Justin Scott Brathwaite  ( transcript summary )

 4.  From Physical Therapist to Clinical Researcher:  “The in-depth content and expert instructors provided me with invaluable insights into the field.”  - Celia Moon ( case study summary )

5.  ICH GCP Usability Confidence :   “Thanks to this course, I feel more competent and confident in my role.” - Stephanie ( case study summary )

6.  Enjoyed Clinical Research Training through Examples  “The real-world examples used throughout the course were incredibly useful for applying theory to practice.”  -Marta Marszalek ( view full case study )

7.  From Clinical Research Receptionist to Certified Study Coordinator with CCRPS:   “I highly recommend this course for its comprehensive approach and practical applications.”  - Katie Decker ( view full case study ) 

8.  From International CRC to U.S. Lead CRC and CRA:   “The flexible online format allowed me to balance my studies with my professional commitments seamlessly.” - Aishwarya Sukumar  ( view full case study )

9.  Learning to Lead Safety Associate: "The course materials were clear, well-organized, and directly applicable to my work.” - Renata Noronha ( view full case study )

10.  From IMG to securing roles as a CRC, CRA, and now a project manager: “Joining this course was a pivotal step in my career advancement.”  - Dr. Vrushali Borawak ( view full case study )

11.  From Physician to Confident Drug Safety Specialist:  “The course provided a robust foundation in the field, which was critical for my professional development.” - Rabiea Bilal ( view full case study )

12.  From plant biologist to clinical recruitment administrative coordinator : “This program is a gateway to extensive knowledge and skills in a supportive learning environment.”  -Olajumoke Owati  ( view full case study )

13.  From International PV Roles To North American Market Success: “The detailed modules prepared me excellently for real-world applications.” - John Vinil ( view full case study )

14.  From Educational Research to Clinical Trials Project Manager:   “I was able to immediately apply what I learned in the course to my job. ” - Rose Hyson ( view full case study )

15.  From Masters in Health Safety to Clinical Researcher:   " I will say quality of delivery, quality of the materials.   - Ossai Opene  ( view full case study )

16.  ICH GCP made her more confident in research:  "this course just overall did a really good job going in depth, which I feel like wasn't just, it wasn't just covered just for the sake of covering content" -  Aastha Shah  (view full transcript)

17.     From Grant Program Manager to Leading Clinical Trials at UCSF :  "it really did a great job of the full scope of clinical research from start to finish.  Since completing the course, I've received a promotion at work. "  -Hannah Fischer  (view HF clinical research training case study)

18.   From Clinical Research Intern to Regulatory Affairs Associate at UPenn: "I would say since then. I've completed this course. It's helped me get my job in regulatory affairs at a clinical research site." - Scott Boyle   (view SB full case study)

19.   From Clinical Research Monitor to Chief Medical Officer for CRO: " And CCRPS has a a complete, you have a really, really good approach to that. Because that is what we offer to our sponsors, quality and safety, because we are all physicians."   - Maria Lopez (full case study report pending)

18.   From International Pharmacist to Pharmacovigilance:   The pharmacist detailed challenges becoming a pharmacist in the US and choosing CCRPS for flexibility. Certification benefits were gaining clarity on research topics and standing out for clinical research roles.   - Ijeoma Osunwa   (full case study report pending)

Clinical Research Associate Foundation

Why become a clinical research associate (cra).

Clinical research is one of the fastest growing industries globally at 6-8% increase every year. The global CRA talent pool grows by about 4-5% and provides great career opportunities. For anyone starting new in the industry, now is the time as 1 out of 4 CRA hires is an early talent and the number of early talent opportunities is growing.

Starting CRA salaries are from about AU$70,000 in Australia, €35.000 in Europe, and US$75.000 in the USA. Next to great starting salaries there are fast career pathways, promotions to come within 2-3 years into professional levels, taking salaries up to AU$130,000 in Australia (excluding bonuses), €45.000 in Europe, and US$95.000 in the USA.

If you have prior qualifications in STEM/Health, you have a good chance of entering this industry as a CRA.

Why choose Clueo Clinical Industry Foundation?

Upon successful completion of this program, you will have all the competencies to enter the industry as Clinical Research Associate (CRA).

What you’ll learn

You will gain the following essential knowledge and skills in our CRA Industry Foundation:

Who is this program for?

This program is ideal for anyone with little to no experience, who is interested in becoming a clinical research associate (CRA) (also known as study monitor or clinical site manager [CSM]).

Requirements

Minimum prerequisite: Tertiary education in a related science or health care discipline.

No prior clinical research experience is necessary to commence this course. It is advantageous, however, if you already have 1-2 years of work-experience in a health- or science-related industry.

The Industry Foundation can be completed in approximately 3-4 months. However, you’ll have up to 365 days from program commencement to complete.

Course Delivery

The Industry Foundation is a self-paced virtual training program thoughtfully designed to tailor to your own individual learning style(s). This means you can complete the program anywhere, at anytime.

Please note: Our virtual live on-demand tutorials facilitated by Industry Experts are only available at specific scheduled times.

Certification

• To obtain the  Certified Completion Certificate in CRA Industry Foundation , you will need a score of ≥ 80% to pass all assessments and quizzes.
• You’ll have unlimited chances to take individual module and course quizzes.
• You’ll have ONLY two (2) attempts to take the Final Assessment, which is a 2-hour exam. Failing the initial 2 attempts will result in a minimum 2-month delay before ONE (1) final attempt can be granted, during which we recommend you relearn the course materials that you have not yet mastered.

If you meet these criteria, your  Certified Completion Certificate in CRA Industry Foundation will be awarded after you have successfully passed the Final Assessment.

You have 3 payment options for this program:

How to enroll

To enroll into this program, please click on the ENROLL NOW button below.

More information

If you would like to know more about our Industry Foundation program, please  contact us .

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Clinical Research Coordinator Associate/Tech./Asst. (underfill)

Job summary.

The Division of Gastroenterology and Hepatology at the University of Michigan is recruiting a full-time Clinical Research Coordinator to join its thriving team. One specific focus for this position will be to help manage projects related to the complications of cirrhosis with a focus on liver cancer development. The primary responsibility for this position will be managing a portfolio of studies around liver cancer screening and development. The responsibilities include consenting patients, interacting with sponsors, and other sites, and maintaining regulatory approval. If desired candidates may also develop an academic resume in the position, with opportunities for writing and publication. All studies are industry or federally funded.

This position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the Clinical Research Technician position is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use. 

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems.  In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Responsibilities*

• Verifying patient eligibility for studies via medical chart reviews 
• Recruiting patients for study participation and obtaining informed consent 
• Coordinating study visits with patients and hepatology providers
• Performing data collection (face-to-face surveys, chart reviews) and data quality assurance checks 
• Performing sample collection and initial processing
• Monitoring study inventory and purchasing supplies 
• Maintaining study data using REDCap (Research Electronic Data Capture) or other programs.
• Preparing study reports, annual reviews, and Institutional Review Board documentation 
• Monitoring and evaluating protocol compliance 
• Assisting with data analysis and preparation of manuscripts and conference presentations 

Characteristic Duties and Responsibilities: Expert level knowledge, skills, and abilities within all 8 competency domains is expected:

• Scientific Concepts and Research Design
• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (GCPs)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwork

Supervision Received: This position reports directly to a faculty PI

Supervision Exercised: None

Required Qualifications*

Clinical Research Coordinator Associate:

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association(SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary.(Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.

Clinical Research Coordinator Technician:

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary.
• Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.) Or An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD Or Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patientcare, related community health and wellness, related clinical information, and research

Clinical Research Coordinator Assistant

• High school diploma or GED is necessary.

Desired Qualifications*

• 4+ years direct related experience 
• Bachelors degree in Health Science or an equivalent combination of related education and experience is desirable. 
• An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable. 
• Associate Degree in Health Science or an equivalent combination of related education and experience is desirable.  

Work Schedule

Work typically occurs during the business hours of the week however some flexibility is possible.

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department.  Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes here .

Underfill Statement

This position may be underfilled at the CRC-Technician/Assistant title based on selected candidates qualifications.

Additional Information

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe. 

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

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Receives direction from principal investigator, supervisor, or other staff involved in research protocol(s). Interacts with various departments within the institution. Works cooperatively with other investigators and personnel at all levels. Interacts with research participants, other research centers, and sponsoring companies to resolve problems and ensure efficient completion of research studies.  Position Overview: (Major Functions and Non-Essential Functions):  Coordinates non-therapeutic (i.e. minimal risk, survey, chart review) clinical research protocols with direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. May assist in complex (i.e. interventional, therapeutic, greater than minimal risk) studies with direction but does not have overall responsibility for these studies. Screens, enrolls, and recruits research participants. Coordinates schedules and monitors research activities and subject participation. Recognizes adverse events, protocol deviations, and other unanticipated problems and reports appropriately. Collects, abstracts, and enters research data. Performs administrative and regulatory duties related to the study as assigned. Some travel may be required. ADDENDUM (if applicable) Protocol Development and Maintenance Activities Responsibilities may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; Institutional Review Board (IRB) submission; and communication with study sites and/or federal agencies regarding study status changes. Participates in other protocol development activities and executes other assignments as warranted and assigned. 

Additional Information: 

This position is onsite and may be eligible for telework 1-2 days per week after a patient and study assessment has been completed and deemed acceptable. While working remotely, staff are expected to be onsite for essential study tasks.  Staff must also successfully complete a 6-month training assessment, demonstrate ability to work independently, be reliable, and exhibit efficiency and accuracy of completing tasks.

Minimum Education and/or Experience Required: (Education Requirements and Experience):  HS Diploma with at least 3 years of experience OR Associate's degree/college Diploma/Certificate Program with at least 1 year of experience, Associate’s in Clinical Research from an accredited academic institution without experience OR Bachelor's degree. Experience should be in the clinical setting or related experience.  

Additional Experience and/or Qualifications: (Has Achieved Competency in the Following Areas, Job Knowledge and Additional Considerations):  Graduate or diploma from a study coordinator training program is preferred. One year of clinical research experience is preferred. Medical terminology course is preferred.  Licensure/Certification Required:  N/A 

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Prasanna Ananth, MD, MPH, Named as an Emerging Leader in Hospice and Palliative Care 2024

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Dr. Prasanna Ananth

Prasanna Ananth, MD, MPH , Associate Professor of Pediatrics at the Yale School of Medicine, was named an Emerging Leaders in Hospice and Palliative Care by the American Academy of Hospice and Palliative Medicine (AAHPM).

AAHPM asked its more than 5,000 members to nominate individuals who are the best and brightest new leaders in the field. Dr. Ananth is one of these physicians recognized by her peers for innovation in and dedication to the medical specialty of Hospice and Palliative Medicine and AAHPM.

“These individuals are enhancing care for seriously ill patients and their families through innovation, education, mentoring and clinical care,” noted Vicki Jackson, MD MPH FAAHPM, President of AAHPM.

Hospice and palliative medicine is the medical specialty that focuses on improving quality of life and relieving pain and other symptoms in seriously ill patients. Palliative care can and should be provided to patients who continue to receive treatments to try to cure or control their disease, regardless of their prognosis. Hospice is a specific type of palliative care for patients whose life expectancy is likely to be six months or less. Hospice and palliative care helps patients and families understand their treatment options and make decisions about their care, and provides information on spiritual and psychosocial services, support for family and caregivers and grief counseling.

Dr. Ananth is a pediatric oncologist and internationally recognized palliative care researcher. Supported through funding from the National Institutes of Health, the St. Baldrick’s Foundation, and the National Palliative Care Research Center, her research focuses on evaluating and improving quality of care for children with serious illness. Says Dr. Ananth upon receipt of this honor, “I am incredibly grateful to my mentors, Drs. Joanne Wolfe, Cary Gross, and Xiaomei Ma, for their steadfast support. A special thank you to Dr. Wolfe for nominating me and for believing in my potential as a researcher and leader. I also want to express my gratitude for my family, who have taught me to maintain grit and courage despite any setbacks in this work.”

More information on this Award, including the list of the award winners is on the Academy’s website www.aahpm.org .

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• Prasanna Ananth, MD, MPH Associate Professor of Pediatrics (Hematology Oncology)