clinical research associate dress code

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Clinical Research Associate (CRA)

This role-based course provides the practical know-how to monitor clinical research sites effectively.

About this Course

A foundational course for individuals considering a career as a clinical research associate (CRA). The course provides broad training on the ethical, regulatory, and practical aspects of monitoring a research site. The modules explain how recent developments in clinical trial organization and conduct have changed the role of CRAs. In addition, the course details the communication and relationships among CRAs, sponsors, contract research organizations (CROs), clinical research coordinators (CRCs), and principal investigators.

Course Preview:

Language Availability: English

Suggested Audiences: Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Faculty, Principal Investigators (PIs), Research Administrators, Sponsors, Students

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations Independent Learner Price: $99 per person

Course Content

" role="button"> scientific concepts and research design.

This module explores how scientific principles inform study design and protocol development. It defines what qualifies as a research question and study hypothesis, lists the components of rigorous clinical research, notes some common weaknesses of different protocol designs, details the central elements of a study protocol, explores how to interpret protocols, and delineates the CRA’s role in monitoring a study site’s implementation of a protocol.

Recommended Use: Required ID (Language): 21178 (English) Author(s): Jessica Rosenbluth, MS - Syneos Health

" role="button"> Ethical and Participant Safety Considerations

This module examines the relevant national and international principles of participant protection in clinical research. It explains the ethical issues involved when working with vulnerable populations and describes the additional safeguards that should be in place to protect such subjects. The module also details the role of the study monitor in ensuring protection of participant rights in an ongoing clinical study.

Recommended Use: Required ID (Language): 21179 (English) Author(s): Natasha Williams, BSc - Narra Consulting LLC

" role="button"> Investigational Products Development and Regulation

This module explores the conception, development, testing, and approval of biomedical products and details the key stages of a biomedical product’s lifecycle. It defines the regulatory pathways for drugs, biologics, and medical devices, while describing how sponsors work with the U.S. Food and Drug Administration to gain approval for product marketing. The module provides CRAs with a working knowledge of the biomedical product lifecycle necessary to facilitate interactions between clinical research sponsors and sites.

Recommended Use: Required ID (Language): 21180 (English) Author(s): Robert Michalik, JD, RAC - RegulatoryPro Consulting

" role="button"> Clinical Study Operations (Good Clinical Practice)

This module provides an overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6(R2) guideline, with a particular focus on sections that are most relevant to the work of a CRA. The module describes how a CRA’s monitoring activities help a site comply Good Clinical Practice (GCP). The module concludes with introduction to the proposed changes found in the E6(R3) update of the ICH guideline.

Recommended Use: Required ID (Language): 21181 (English) Author(s): Chinonso Singleton, MS - LIBRE, LLC

" role="button"> Understanding the Clinical Monitoring Plan

This module covers the roles and responsibilities of study monitors and details a monitoring plan's creation, purpose, and contents. It outlines risk-based and remote monitoring approaches and contrasts these with an earlier traditional model for monitoring. The module also focuses on the essential components of a monitor’s communication with investigators, study staff, and sponsors.

Recommended Use: Required ID (Language): 21182 (English) Author(s): Natasha Williams, BSc - Narra Consulting LLC

" role="button"> Implementing the Monitoring Plan

This module describes the preparation for and conduct of different site visits. It identifies the central actors involved and the common interactions among them. The module also details the key components of a visit follow up.

Recommended Use: Required ID (Language): 21183 (English) Author(s): Natasha Williams, BSc - Narra Consulting LLC

" role="button"> Emerging Clinical Trial Methods and Technologies

This module defines the purpose and use of emerging technologies for study management and data collection. It describes how these technologies enhance risk-based monitoring (RBM). In addition, the module discusses how decentralized clinical trial (DCT) modules are shaping the future of clinical trial conduct.

Recommended Use: Required ID (Language): 21184 (English) Author(s): Natasha Williams, BSc - Narra Consulting LLC

" role="button"> Data Management and Informatics

This module defines the core aspects of data management, describes quality clinical trial data, defines data-related milestones, and connects data processes to related systems and software. The module also outlines selected data-handling processes and provides CRAs with information on operational activities to maintain data quality at their assigned clinical trial sites.

Recommended Use: Required ID (Language): 21185 (English) Author(s): Chinonso Singleton, MS - LIBRE, LLC

" role="button"> Leadership, Communication, Professionalism, and Teamwork

This module describes some principles and practices of leadership, communication, professionalism, and teamwork related to clinical research. It describes how a CRA can leverage soft skills to effectively manage stakeholder relationships in a clinical trial.

Recommended Use: Required ID (Language): 21186 (English) Author(s): Clareece West, BSc - West-Fenn Enterprise, LLC

" role="button"> Who should take the Clinical Research Associate course?

Learners who wish to gain foundational knowledge of clinical research site monitoring should take this course to prepare for a career as a clinical research associate (CRA). The course is ideal for clinical research coordinators (CRCs) looking to transition to becoming CRAs and for organizations looking to onboard new CRAs.

Suggested audiences include new Clinical Research Associates, Clinical Research Coordinators, Contract Research Organizations, Faculty, Principal Investigators, Research Administrators, Sponsors, and Students.

" role="button"> Why should someone take the Clinical Research Associate course?

This role-based course provides the practical know-how to monitor clinical research sites effectively. It provides broad training on the ethical, regulatory, and practical aspects of monitoring a research site. The modules explain how recent developments in clinical trial organization and conduct have changed the role of CRAs. In addition, the course details the communication and relationships among CRAs, sponsors, clinical research coordinators (CRCs), and principal investigators.

" role="button"> How does the Clinical Research Associate course complement other CITI Program Courses?

Clinical Research Associate is a helpful complement to CITI Program’s Clinical Research Coordinator (CRC) Foundations and Clinical Research Coordinator (CRC) Advanced courses. It provides the next set of tools required for research monitors. CRCs looking to become CRAs will find that Clinical Research Associate is essential to making this professional transition.

" role="button"> What are the required and supplemental modules?

The modules for the Clinical Research Associate course are:

• Scientific Concepts and Research Design
• Ethical and Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (Good Clinical Practice)
• Understanding the Clinical Monitoring Plan
• Implementing the Monitoring Plan
• Emerging Clinical Trial Methods and Technologies
• Data Management and Informatics, and
• Leadership, Communication, Professionalism, and Teamwork

The course is designed to be completed sequentially through all nine modules (we recommend they are set as “required”).

" role="button"> Is this course eligible for continuing medical education credits?

The course does not currently have CE/CME credits available.

" role="button"> How long will the course take a learner to complete?

This course consists of nine modules. Each module contains detailed content, a quiz, images, supplemental materials, and case studies.

Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. As a rule of thumb, modules can take about 30 to 45 minutes to complete, which means it could take around 4.5 to 5.5 hours to complete.

Related Content

CRC courses focus on key topics essential to the conduct of clinical research. They are specifically tailored to the needs of clinical research coordinators.

Discusses the importance of CRA soft skills in building productive relationships with sites and sponsors.

Discusses the process and content of a CRA’s interim monitoring visit.

Details ways to produce productive partnerships between clinical research associates and clinical research coordinators.

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Clinical Research Coordinators 11-9121.01 Bright Outlook Updated 2024

Plan, direct, or coordinate clinical research projects. Direct the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives. May evaluate and analyze clinical data.

Sample of reported job titles: Clinical Coordinator, Clinical Program Coordinator, Clinical Program Manager, Clinical Research Administrator, Clinical Research Coordinator, Clinical Research Manager, Clinical Research Nurse Coordinator, Clinical Trial Coordinator, Clinical Trial Manager, Research Coordinator

See the easy-read overview for Clinical Research Coordinators at My Next Move

See the easy-read overview for clinical research coordinators at my next move for veterans, ver la perspectiva general fácil de leer para coordinadores de estudios clínicos en mi próximo paso, occupation-specific information, technology skills, occupational requirements, work activities, detailed work activities, work context, experience requirements, training & credentials.

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Related occupations, professional associations.

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How much education does a new hire need to perform a job in this occupation? Respondents said:

• 60%   responded: Bachelor’s degree required
• 12%   responded: Post-secondary certificate required
• 9%   responded: Some college, no degree required more info
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• Dependability — Job requires being reliable, responsible, and dependable, and fulfilling obligations. Related occupations
• Self-Control — Job requires maintaining composure, keeping emotions in check, controlling anger, and avoiding aggressive behavior, even in very difficult situations. Related occupations
• Attention to Detail — Job requires being careful about detail and thorough in completing work tasks. Related occupations
• Initiative — Job requires a willingness to take on responsibilities and challenges. Related occupations
• Concern for Others — Job requires being sensitive to others' needs and feelings and being understanding and helpful on the job. Related occupations
• Adaptability/Flexibility — Job requires being open to change (positive or negative) and to considerable variety in the workplace. Related occupations
• Stress Tolerance — Job requires accepting criticism and dealing calmly and effectively with high-stress situations. Related occupations
• Achievement/Effort — Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks. Related occupations
• Independence — Job requires developing one's own ways of doing things, guiding oneself with little or no supervision, and depending on oneself to get things done. Related occupations
• Persistence — Job requires persistence in the face of obstacles. Related occupations
• Leadership — Job requires a willingness to lead, take charge, and offer opinions and direction. Related occupations
• Social Orientation — Job requires preferring to work with others rather than alone, and being personally connected with others on the job. Related occupations
• Analytical Thinking — Job requires analyzing information and using logic to address work-related issues and problems. Related occupations
• Innovation — Job requires creativity and alternative thinking to develop new ideas for and answers to work-related problems. Related occupations

Wages & Employment Trends

Source: Bureau of Labor Statistics 2023 wage data external site and 2022-2032 employment projections external site . “Projected growth” represents the estimated change in total employment over the projections period (2022-2032). “Projected job openings” represent openings due to growth and replacement.

Job Openings on the Web

Disclaimer: Sources are listed to provide additional information on related jobs, specialties, and/or industries. Links to non-DOL Internet sites are provided for your convenience and do not constitute an endorsement.

Actively assisted with the O*NET data collection, helping to identify occupational experts who can be surveyed about their work in the occupation.

National Associations

• American Association for the Advancement of Science external site
• Drug Information Association external site
• Professional Science Master's external site

Accreditation, Certification, & Unions

• Association of Clinical Research Professionals external site
• Society of Clinical Research Associates external site

Clinical Research Associate: A Full Guide on Becoming A CRA

Clinical Research Associate

A complete guide on how to become a clinical research associate.

Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online to start a career in the frontiers of medical research and patient care.

As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or just did not meet your expectations for your science degree.

This is why a career as a CRA should be considered with clinical research coordinator training. We train over 500 students each month in clinical research coordinator training and clinical research associate training (depending on prior background).

For those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career.

Because the position is unlike actually working in the lab and more of a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.

Best of all; many of these positions accept remote staff (and some allow you to travel 45-75% with full expenses including travel, accommodation, meals, and other per-dime expenses covered).

Clinical Research Training can help you save money while also increasing your salary. CRA’s with our level of training can expect to make between $6,500-$12,000 a month with an estimated promotion rate of 33% a year: an amount that is uncommon in other science-degree careers.

CCRPS is one of the only major US-based ACCRE, ACCME, ANCC, ACPE, and Transcelerate Biopharma accredited CRA certification courses that accepts students with no prior background for certification. T

his is because our course is thorough and created by Senior CRAs who have been in the field for long enough to understand what you need to know to begin working and applying. The course can be completed in as little as 7 days with dedicated full-day study time.

Clinical Research Associate Certification Qualifications

Foreign Doctors Welcome : A Clinical Research Associate or Coordinator plays a vital role in directing and supervising clinical trials conducted by physicians, nurses, and other science professionals. This career path is particularly attractive to many foreign doctors with completed medical degrees (MBBS) who can utilize their expertise in the US healthcare system by pursuing a CRA career instead of taking the USMLE or repeating residency training. For those interested in coordinating aspects, consider the Clinical Research Coordinator course .

Distinct Skillset : Unlike the traditional medical field you may be familiar with after years of schooling, Clinical Research Associate training provides a distinct and valuable skillset. For comprehensive understanding of Good Clinical Practice, see the ICH-GCP course .

Most Extensive Online Course : Our program goes beyond basic introductions, offering a comprehensive curriculum with over 110 modules – the most extensive Clinical Research Associate course available online. This in-depth training ensures you're well-prepared to secure a coveted CRA position.

Superior Coursework : Securing a CRA role is a strategic career move compared to the limitations of many traditional medical positions. While generic courses abound, we've observed that graduates often struggle due to a lack of substantive content. Our Clinical Research Associate course addresses this gap by providing Senior Clinical Research Associate-level training through 110 intensive modules grounded in the latest scientific principles. For those looking to assist in clinical trials, the Clinical Trials Assistant Training may also be of interest.

Diverse Career Opportunities : This high-demand science-based medical field offers diverse opportunities:

Work in the Private Sector : Pursue a CRA career with renowned pharmaceutical companies like Pfizer. Enhance your skills with the Advanced Clinical Research Project Manager Certification .

Academic Opportunities : Work in the academic sphere at medical schools. Those aiming for higher responsibilities may consider the Advanced Principal Investigator Physician Certification .

Unmatched Flexibility and Knowledge : In addition to our exceptional course content, we boast the largest number of clinical research courses available online, providing you with unmatched flexibility and knowledge. For those interested in safety monitoring of drugs, the Pharmacovigilance Certification and Medical Monitor Certification can enhance your capabilities in these critical areas.

Why Take A CRA Certification Course

 The role of the clinical research associate is to ensure that medical devices, new treatments and new drugs are approved for patients' use.

This field is taken as a certificate program course in many schools. For example, you may find associate degree programs. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.

If you opt for a fully online program, you can still get an immersive education. Different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as the lecturers.

Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order for students to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.

These certificate programs are generally designed for professionals that are already in the medical fields (like medical assistants or nurses) and are interested in moving to the field of clinical research.

They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.

Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials.

During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.

The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective. The need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience in clinical trials.

Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.

In applying for the post of a clinical research associate , ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to.

Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies, you might increase your chances.

Further certification can enhance your resume such as the ACCRE accredited CRA program which contains 110 learning modules for Clinical Research Associate Training and Placement

The Best CRA Certification Course For Entry-Levels

There is a huge shortage of well-trained CRAs, but many companies are reluctant to hire untrained entry-level clinical monitors because of patient and trial safety. Because of this, even the beginner entry-level jobs require certification or training.

Our program is considered one of the top clinical research graduate programs online. Most courses provide very light training that may look good because of the company names, but alone is not sufficient to pass the interview rounds a company conducts.

Because our modules are prepared help even Senior Clinical Research Associates, we find more of our students with no background quickly passing their interview rounds.

CCRPS Course covers double to triple the amount of course content than other courses. While many courses are simply 5-20 simple interactive modules, our course covers 140 dense modules in thorough detail.

After each session, students can ask their questions privately with the course instructor, all of whom have 15+ years of CRA experience.

Currently, 82% of our students are hired within the first month of taking the course. Students with limited background or those looking to gain extra experience are offered a remote internship of up to 6 months during the time they are interviewing.

This advantage allows many students with limited experience to get hired with a higher paying job than previously offered.

While a majority of our students are physicians, a majority of the CRA workforce are Science Grads and Nurses. nonetheless, we train all students at a Senior CRA level regardless of background because clinical research monitoring is vastly different from any lab or science course you may have taken.

Clinical research associates are given the protocol of a study including all medical protocol that must be followed but because they do not diagnose or treat. Medical knowledge is supplemental but not sufficient in this career path.

This is the main reason why our Clinical Research Training includes all possible scenarios you may face at the protocol and guideline level in your future company.

How To Get Experience For Clinical Research Associate Jobs

CCRPS, like other educational institutes, is only associated with educating and certifying clinical research professionals so we do not provide job placement. We want to make sure you apply with your best foot forward. Below are links we readily refer to graduates who are looking for job support. Having a great CV and cover letter are essential to applying for jobs. Recruiters are paid by the company which hires you and thus are free for searching employees. Be realistic but also be driven. Make sure you get continue reaching out until you get a true rejection from any job you apply to as they may never have seen your application if you received no response.

Clinical Research Job Advising: Kunal at ClinicalTrialPodcast

Free Resume Review: TopCV TopCV provides a free review and feedback for your current resume.

Resume Distribution: ResumeRabbit Resume rabbit distributes your resume to 60 job posting sites.

Clinical Research Recruiters: I-Recruit I-Recruit distributes your resume to clinical research recruiters.

Clinical Research Job Bulletin: Indeed Indeed usually provides the most uptodate job bulletin for clinical research jobs

Always use a cover letter specific for the company and job when applying if you are not using a recruiter.

The ICH-GCP in Clinical Research

Regardless of the type of clinical research or function of an IP being tested, it is important that clinical research should meet two critical criteria:

The clinical research process should respect the rights, freedom and dignity of tested patients (human participants).

Data from the clinical research process should be accurately collected, safely stored, rigorously scrutinized and correctly interpreted.

One way to ensure that these requirements are met is to follow a set of internationally recognized and accepted standards for clinical research. 

Most countries across the world today follow ICH-GCP, that is, International Committee for Harmonization of Good Clinical Practice guidelines in conducting clinical research on human participants7.

The ICH-GCP outlines procedures and precautions that are essential in order to protect the safety and wellbeing of human research participants during clinical research, and to ensure the integrity of data from clinical research studies.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.z

Qualifications and Qualities of a CRA

According to the International Accrediting Organization for Clinical Research (IAOCR), candidates for CRA positions usually hold either a biological science degree, or one in medicine or nursing10. 

The New Scientist recommends that aspiring CRAs should possess a good working knowledge of one or more of the following subjects – anatomy, biology, biochemistry, chemistry, immunology, microbiology, pharmacology, physiology or toxicology11.

In addition to a background in medical or life sciences, a CRA is required to have a good grasp of data management, including Electronic Data Capture (EDC), data analytics and reporting12.

Sketching the CRA work profile, the authors Diane St. Germain and Marjorie Good state that CRAs are the ones who scrutinize clinical study data most closely from start to finish—as a result, they are often the first to notice critical patterns and interesting trends, and to report these to the research team as well as to the CRO13.

Equally if not more importantly, a CRA must possess a high level of emotional and interpersonal savvy. This is a crucial area, since a CRA’s success hin ges upon his/her ability to elicit the best from team members, in terms of both performance and probity. 

Core Competency Framework for CRAs

To illustrate, the ACRP’s ‘Core Competency

Framework for Clinical Study Monitoring’

requires that a CRA should be able to identify

and correct compliance violations at a study

site. The CRA must not only bring such

violations to the attention of site staff, s/he

must induce them to take corrective action,

as well as reporting the matter and even

escalating it, where necessary14.

The table below summarizes the ideal

competencies of a CRA, and provides

insights on how each ability contributes to

the CRA’s performance.

CRA Career Path

In the past, CRA positions were often filled by individuals with medical or nursing backgrounds, with little thought given to their lack of research training15. As awareness grew about the importance of research experience for a CRA, employers began preferring those with years of experience in clinical research settings, such as Clinical Trials Assistants (CTAs) and Clinical Research Coordinators (CRCs)16.

However, in recent years, the focus has shifted once again from a tenure-based mindset to a skills-based evaluation17. In part, this change has been brought about by the growth in professional courses and training programs in the field. 

For instance, many leading US Universities today offer master’s programs in clinical research18. In addition, there are some widely recognized certification programs for clinical research associates, such as those offered by the ACRP19 and the Society of Clinical Research Associates (SOCRA) 20.

Note: You must already be working as a CRA to qualify for the ACRP and SOCRA certification programs.

A Toe in the Door: CRA Certification for a Non-CRA

By this point, you might be wondering, “I have no research experience… I’ve never worked as a Clinical Trials Assistant (CTA) or a s a Clinical Research Coordinator (CRC). Nor do I have a degree in Clinical Research. Can I still become a CRA?”

The simple answer is, yes, you can.

You might be a life sciences graduate looking for a lucrative career in the pharmaceutical or biotechnology sectors. Or, you’re excited by a career in research, but unsure whether the drudgery of a Ph.D. is your thing.

Maybe you’re just looking for a job that represents a great option for someone with your combo of science background plus detail-orientedness.

Whichever of these descriptions best applies to you, a career as a Clinical Research Associate could be exactly right for you.

With the right training, you can be recruited directly to a Clinical Research Associate position, even without a background in clinical research.

So, what kind of training will help me break through the ‘experience’ barrier and land a job as a CRA?

As you’ve already gathered from the table, the skill-set required to be a successful CRA is pretty extensive.

Aside from an in-depth knowledge of scientific and medical concepts and principles, a CRA must have a sound grasp of medical research regulatory requirements, a penchant for being thorough and systematic, as well as a knack for coordinating and managing people with diverse skills, roles and backgrounds.

To our knowledge, CCRPC’s ‘Advanced Clinical Research Associate Certification’ (ACRAC) is one of a kind: The ACRAC is the only multi-accredited* certification program in the US that offers the kind of exhaustive as well as intensive training that equips candidates from a non-clinical background with the abilities and competencies that make a good CRA.

Best of all? The ACRAC is open to fresh graduates holding a B.S. degree in any of the life sciences, with no requirement for prior exposure or experience in clinical research.

*The ACRAC program offered by CCRPC is accredited to ACCRE (Accreditation Council for Clinical Research & Education), ACCME (Accreditation Council for Continuing Medical Education), ACPE (Accreditation Council for Pharmacy Education), ANCC (A merican Nurses Credentialing Center), as well as Transcelerate Biopharma.

Training to be a CRA through CCRPS ACRAC

The ACRAC program includes over 100 course modules that cover all the important knowledge domains and skill-sets required by a CRA.

Designed for a total study time of approximately 250 hours, this training program can be completed at your own pace, or, for those able to dedicate the whole day to study, in as little as two to three weeks.

Starting with a broad overview of clinical research jargon and terminology, the course walks students through the principles of Good Clinical Practice, familiarizing you with the relevant sections of the ICH-GCP and the FDA’s E6(R2).

The program places particular emphasis on ethical practices in research with vulnerable populations.

Students going through the ACRAC are trained in all major aspects of designing a Clinical Trial Protocol in keeping with the Code of Federal Regulations (CFR).

They additionally learn the steps involved in the IRB/IEC approvals process and how to prepare required documents.

Finally, students become aware of the importance of pharmacovigilance and the regulatory process for new drug testing.

A major chunk of the ACRAC certification centers around equipping the CRA for day-to-day responsibilities, such as different types of site visits – preliminary (Site Qualification), preparatory (Site Initiation) and progress monitoring visits (Routine Monitoring).

Crucially, the ACRAC covers essential documentation such as the Case Report Form and Trial Master File, as well as electronic data capture (EDC) and remote monitoring systems.

A vital component of the training program involves empowering students to tackle challenging situations.

For a CRA, these include identifying protocol deviations and violations, and recognizing as well as reporting research fraud and ethical misconduct.

In addition to its comprehensive coverage, the ACRAC certification offers the great advantage of including 17.5 CME credits – that is, course credits that count towards ‘Continuing Medical Education’.

These credits can be used by individuals desiring to further their education and/or careers in healthcare-related fields, including medicine, nursing, pharmacy and research.

Clinical Research Associate Training

Get ahead in clinical research with advanced accredited online CRA certification for $450. Demo our on-demand course below.

Clinical Research Associate Certification

Advanced clinical research associate certification (acrac).

Chapter 1: Introduction

This chapter orients you to the concept of Continuing Medical Education (CME) and outlines how the CCRPS CRA program contents meets AMA requirements for CME. Given that, across the US, physician practitioners are required to complete between 20 and 50 hours of CME credits yearly, the ACCME-accredited CCRPS CRA course can be used not only to build knowledge and skills in the field of clinical trial management, but also to further a successful medical career. Additionally, the introductory chapter introduces you to the clinical terminology and abbreviations commonly encountered in clinical research, for example, Investigational Product (IP), Good Clinical Practice (GCP), Institutional Review Board (IRB) and so on. 

Chapter 2: Roles and Relationships in Clinical Trials

The unit presents the foundational background to beginning and building a career as a clinical research associate (CRA). As you know, a CRA plays a critical role in setting up as well as monitoring the clinical trials process for an investigational product or IP – a medical drug or device under development. In this unit, you will learn how a CRA interacts with other stakeholders, including the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC),other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

Chapter 3: Sponsor and Investigator Roles

In this unit, you will gain insight into the ICH-GCP guidelines, particularly addendum E6, sections 2 through 5, which outline procedures and precautions essential for protecting the safety and wellbeing of human research participants during clinical research. These include guidelines for obtaining informed consent from human subjects, maintenance of trial records, reporting of compliance, safety and research progress, as well as procedures for suspension or termination of the trials process. The chapter familiarizes you with the critical importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

Chapter 4: Clinical Trial Design

In this chapter, you will acquire insight into the different phases of the clinical trials process, from the pre-clinical phase through Phases 0 to 4 of clinical testing. The unit will familiarize you with important concepts of clinical trials, such as the structure and goals of each phase of clinical trials, approaches to dosing, toxicology of pharmaceutical products, in vitro and in vivo testing, dose escalation and so on. Finally, the chapter reviews the FDA’s drug approval process.

Chapter 5: ICH-GCP – Overview

The chapter dives deep into GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as  Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

Chapter 6: Ethical Research in Vulnerable Populations

The unit provides a detailed walk-through of the regulations and compliance requirements for conducting clinical trials with human subjects who meet the definition of a ‘vulnerable population’, including pregnant women and fetuses, children, mentally incapacitated individuals (those with cognitive functioning impaired by neurolopsychological conditions or chronic substance abuse), as well as prisoners. You will acquire familiarity with the challenges of research in such populations, including the requirement for parental consent, fair but not excessive incentive, justifiable deception or incomplete disclosure, coercive practices and so forth.

Chapter 7: Adverse Events

Through this module, you will gain a bird’s eye view of the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects. 

Chapter 8: Clinical Trial Protocol

The chapter provides an in-depth tutorial on the structure and elements of a CTP or clinical trial protocol, as well as guidelines on writing a CTP. Important concepts reviewed include study Risk Benefit Analysis (RBA), study sample statistics (sample size, statistical power, plan for data analysis), risk management and study administration. Additionally, the module covers concepts central to study sample selection, addressing inclusion and exclusion criteria, especially safety and ethics considerations in sampling. 

Chapter 9: Protocol Deviations and Violations

Through this unit, you will gain familiarity with the many potential causes of protocol deviations and violations, learning to distinguish between minor (deviations) and major departures or violations of protocol. Content provides understanding of the most commonly occurring violations, including both minor (off-schedule subject assessments, subjects’ use of prohibited drugs, and so on) as well as major violations (failure to obtain informed consent, failure to report AEs and so forth). Further, the chapter reviews principles for reporting protocol deviations, IRB approval for planned deviations and related concepts. 

Chapter 10: IRB and DSMB

This chapter briefly reviews the history of IRBs and examines the principles guiding IRB decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.   

Chapter 11: Review Questions

The module provides a self-assessment tool by including questions that review the content covered in previous chapters. The set of 71 questions examines all aspects of ICH-GCP previously discussed.

Chapter 12: Site Monitoring Visits

In this module, an overview is provided of the different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

Chapter 13: Site Qualification Visit (SQV)

The chapter gives an in-depth understanding of the stages and steps involved in selecting a study site. Elements reviewed within the module include the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). Importantly, the module reviews the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.  

Chapter 14: Site Initiation Visit (SIV)

The module dives into the details of an SIV or site initiation visit. You will review the procedure for pre-SIV preparation, including filing for IRB and other necessary approvals, permits and licenses. Additionally, the chapter examines elements of the SIV agenda, mainly orientation and training of site staff, creation of important study-related documents such as the Trial Master File (TMF) and post-SIV filing of compliance documents such as FDA form 1572 and Financial Disclosure Form (FDF) for relevant site personnel. 

Chapter 15: Routine Monitoring Visit (RMV)

In this unit, the elements of a routine or periodic monitoring visit are discussed in detail. You will become familiar with the agenda of an RMV, which prioritizes receiving updates on AEs from site staff (incidence, documentation, seriousness and so on), as well as oversight of the overall progress of trials. The chapter covers different approaches to site monitoring, contrasting traditional (full-scale) monitoring with risk-based monitoring (RBM), as well as comparing on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is central to obtaining meaningful, high-quality data from clinical trials.

Chapter 16: Site Close-Out Visit (SCOV)

The module gives you a comprehensive overview of the protocol and procedures involved in terminating or closing out a trial site. Aspects covered in the chapter include pre-SCOV preparations such as IRB notification and schedule coordination among site staff (PI, other investigators, medical staff) and monitoring team (CRC, CRAs and so on), agenda for an SCOV – drug inventory management, database verification and lockdown, subject intimation and completion of all subject-related documents, staff-related documentation as well as other administrative tasks including close-out report compilation.

Chapter 17: Tools for Monitoring Visits

This unit outlines a host of tips and tools that can help a CRA in successfully tackling the complex process of monitoring clinical trials. The chapter lists numerous physical accessories you can use for effective monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions. 

Chapter 18: Audit and Inspections

The module deals with one of the most crucial and often most feared aspects of a CRA’s career – audits and inspections by the CRO (sponsor), FDA or other regulatory authority. Starting from the basic distinction between an audit and an inspection, the chapter covers in detail the protocols for both audits and inspections. Crucially, the chapter will enable you to grasp the difference between a routine audit/ inspection and a ‘for-cause’ audit/ inspection. Further, it lays out the sequence of an FDA inspection in full (including a detailed walk-through of the FDA BIMO or Biomedical Research Monitoring Program inspection), and provides important guidelines on the do’s and dont’s for CRAs during an audit/ inspection, such as the critical ‘3 to 5 minute rule’. You will acquire familiarity with important audit and inspection-related documents such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation) as well as the Establishment Inspection Report (EIR) prepared by the auditor/ inspector. Finally, you will gain insight into the classes of observations provided in an EIR, including NAI (no action indicated), VAI (voluntary action indicated) and OAI (official action indicated)—the last is commonly termed an ‘FDA warning letter’.

Chapter 19: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of clinical trial quality monitoring, including monitoring visits, tools as well as audits and inspections.

Chapter 20: SDV and Informed Consent

In this chapter, the ICH-GCP section 4.8 guidelines on obtaining informed consent from subjects are discussed in detail, highlighting the need for using non-technical language, transparent delineation of risks, consent without undue influence, obtaining consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to conform to ICH-GCP requirements that subject trial data (as recorded in Case Report Forms or CRFs) must correspond to source data (previous medical records).

Chapter 21: Case Report Form

The module provides an in-depth tutorial on the structure and elements of a Case Report Form or CRF, including the different forms for PI verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events and so on. In addition, the chapter outlines important data notation rules, such as the use of accepted acronyms (‘ND’ for missing data and ‘UNK’ for unknown information, MM-DD-YY format, time-stamp data and so forth), as well as guidelines for the design of CRFs (such as consistency of notation, avoidance of data fields that can be computed and of duplicate data fields and so on).

Chapter 22: Quality Control and Safety

Within this unit, you will learn the central concepts of Quality Control (QC) in the context of clinical trials, including definitions of QC and its relationship with the complementary process of Quality Assurance (QA), the use of Key Performance Indicators (KPIs) in QC, need for a Corrective and Preventive Action (CAPA) plan and so on. Additionally, the module examines the QA process, focusing on the central role of RBM or risk-based monitoring in present-day QA as well as providing guidelines on Quality Metrics (QMs) for evaluating the trials process. The chapter also reviews ICH-GCP guidelines on subject safety, underlining risk-benefit assessment, stoppage rules (for instance, in case of SAEs) and reporting responsibilities. Finally, it introduces the FDA’s Human Research Protection Program (HRPP) as a platform that provides training and support for personnel involved in clinical trials.

Chapter 23: Technology in Trials

In this chapter, an in-depth tutorial is provided of the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs) including IVRS and IWRS (Interactive Voice and Web Response Systems, respectively) as well as RTSM systems for Randomization and Trial Supply Management are examined.  The unit reviews the benefits of standardized data management and data sharing, approaches to database management and the concept of an Independent Data Monitoring Committee (IDMC). Critical elements of data integrity, such as proper anonymisation and coding, completeness of data, data safety precautions and logging of site visits and other progress reports are highlighted. The unit further examines the essential features of a good Clinical Data Management (CDM) system that complies with FDA CFR Title 21 and HIPAA regulations, such as setting access privileges, tracking changes and updates, data security and locking, flagging and reconciliation of AEs and so forth. Finally, the chapter looks at CTMSs (Clinical Trial Management Systems) in depth, covering the aspects that allow management of day-to-day trials in multi-site studies. 

Chapter 24: Modernized Monitoring (Remote, Risk-based, Centralized)

 This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements. Finally, the unit examines how risk-based monitoring approaches have allowed centralized monitoring to evolve into a cost-effective and safe method for clinical trial monitoring.

Chapter 25: Pharmacovigilance and Regulatory Affairs

Through this unit, you will gain insight into the process and rationale behind pharmacovigilance (PV) and its central role in the clinical trials process. The chapter reviews the statistics on AEs, distinguishes between Type A and Type B AEs, and profiles seriousness of ADRs or Adverse Drug Reactions as well as the iGuard Drug Risk Rating System. Importantly, the unit covers ADR causality assessment in detail, including both severity and probability assessment. An important element of PV addressed in this module is the Individual Case Safety Report (ICSR), its structure, content and role in trial monitoring. Other concepts discussed include types of PV inspections (routine vs. ‘for cause’), PSURs or Periodic Safety Update Reports and study criteria for instituting DSMBs (Data Safety Management Boards). Finally, the module also reviews the domain of Regulatory Affairs (RA) as a function of PV, outlining roles and responsibilities of RA personnel as well as the importance of RA in streamlining the process of drug development by ensuring compliance throughout manufacturing, clinical trials, marketing and advertising.

Chapter 26: Investigational Product

In this chapter, an in-depth review is provided of the protocol for receiving, storing and dispensing the IP or investigational product. At every stage, guidelines lay down strategies for ensuring verifiability, accountability and safety of both study subjects and staff. Thus, IP handling precautions include the need for logging date of manufacture, temperature throughout transit, as well as batch number and individual unit numbers (such as bottle or tube identifiers) carefully and accurately, as well as recording shipping details and filing shipping receipts. Additionally, the unit addresses the need for IP dispensing precautions, such as limiting dispensation to authorized personnel only, as well as maintaining individual subject IP logs.

Chapter 27: Local and Central Labs

The module profiles the evolution of lab testing in clinical trials, from error-prone localized laboratory testing to centralized testing that allows homogeneity of testing procedures and measurements, thus minimizing errors and improving outcomes. The chapter reviews standards for clinical trial laboratories as per the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments), as well as providing guidelines for lab audits, including fire safety, protective gear, staff training and so forth.

Chapter 28: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of trial documentation (SDV, CRF, ICSR), quality control, pharmacovigilance, as well as IP and lab guidelines.

Chapter 29: Regulatory Documents in Clinical Trials

The chapter reviews essential documentation to be created and maintained throughout the course of the clinical trials, including the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312, besides ethics approval documents such as the IRB-approved protocol, informed consent form, subject education and study advertising materials. You will acquire in-depth familiarity with each of these forms, and learn the importance of maintaining and updating records, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. In addition, the unit summarizes the need for filing documents outlining study- and site-specific procedures, including SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

Chapter 30: CFR Title 21 Part 11 – Electronic Signatures

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR), including Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56) and so on, Series on food (100), pharmaceuticals (200 and 300) and so on, as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES), laying down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

Chapter 31: New Drug Application

Through this module, you will gain knowledge of the FDA process for evaluating a drug under development, and the role of a CRA in streamlining this process. An important distinction covered here is the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The chapter discusses in-depth the criteria used in evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, the unit covers FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators. 

Chapter 32: Trial Master File

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF. 

Chapter 33: Disclosures and Payments for PI, Site, Patients

In this chapter, FDA guidelines regulating financial disclosure are discussed in-depth, covering the definition of ‘conflict of interest’ and the stipulations of Title 21 Section 54 on disclosure requirements. The unit helpfully contrasts FDA requirements with Canadian and UK/EU policies. You will study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on ‘fair market value’ as well as the Federal ‘Anti-Kickback Statute’. The unit contains guidelines on clinical trial budgeting and subject payments. Finally, the chapter reviews IRB guidelines on advertising to recruit human participants for clinical trials, including stipulations against misleading and coercive language, as well as excessive incentives.

Chapter 34: Patient Recruitment, Retention and Compliance

The unit provides an overview of the process of patient (subject) recruitment in clinical trials, from population research to identify motives for participation, to media support for building up public awareness and interest, to community and physician outreach for referrals and enrollment. Additionally, the chapter identifies common barriers to meeting recruitment goals and outlines strategies for maximizing recruitment, such as relaxing overly stringent criteria, offering reasonable incentives such as travel reimbursement and highlighting benefits of participation. Similarly, the unit covers common causes of patient drop-out as well as strategies for minimizing drop-outs, such as improving patient experience (increased attention and listening to patients, flexible scheduling of visits to suit patients’ convenience and so on). Finally, the unit discusses novel strategies to increase patient retention and improve compliance in clinical trials; these techniques harness technology to yield better outcomes, for example, simplifying form completion through digitized forms with auto-fill features, gamifying elements of compliance reporting, and so forth.

Chapter 35: Misconduct and Fraud

This module discusses the various motives for committing scientific fraud and the fallout of fraudulent practices in clinical trials. A scale for classifying errors in clinical trial data is presented, with ‘honest, isolated mistake’ at one end of the spectrum and ‘deliberate data falsification with malicious intent’ at the other. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will gain familiarity with the signs to watch out for during the actual clinical trials process. 

Chapter 36: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, including questions on all aspects of regulatory documents, site documents (TMF and contents), trial budgeting and payments, patient recruitment and scientific fraud.

Chapter 37: Site Visit Templates 

This module contains a set of templates that you can use for documenting the details of site monitoring as a CRA, either in their current form, or in a form adapted to the needs of your own study. The templates included in this unit include:

Site Qualification Visit (SQV) – checklist for preparations, questionnaire for assessing the site prior to the actual visit, assessment form and follow-up letter

Site Initiation Visit (SIV) – agenda for visit, confirmation letter to request PI attendance during SIV, report following SIV

Routine Monitoring Visit (RMV) – confirmation letter to request PI attendance, report following RMV, follow-up letter

Site Close-Out Visit (SCOV)  – confirmation letter to request PI attendance, agenda for SCOV, report following SCOV, follow-up letter

CRA transition letter  – document notifying site PI of appointment of new monitor (yourself as CRA) 

Chapter 38: Interviewing and Career

In this unit, you will find suggestions and recommendations for making a positive impact in interviews for CRA positions, as well as tips and strategies for making rapid progress in a clinical research career.

Chapter 39: Final Examination

This module comprises a comprehensive 51-item, self-paced quiz to assess your competency in the skills and knowledge required for a Clinical Research Associate position. 

https://www.beroeinc.com/category-intelligence/clinical-research-organizations-market/

https://www.linkedin.com/jobs/search?keywords=Clinical%20Research%20Associate&location=United%20States&geoId=103644278&trk=public_jobs_jobs-search-bar_search-submit&position=1&pageNum=0

https://www.centerwatch.com/articles/24791-demand-for-experienced-clinical-trial-professionals-outpacing-supply-acrp-says

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3317309/

https://www.niaid.nih.gov/research/dmid-investigational-product

https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

Dixon JR. 1999. The international conference on harmonization good clinical practice guideline. Quality Assurance. 6(2): 65-74. DOI: 10.1080/105294199277860

https://www.fda.gov/files/drugs/published/E6%28R2%29-Good-Clinical-Practice--Integrated-Addendum-to-ICH-E6%28R1%29.pdf

https://www.who.int/groups/research-ethics-review-committee/recommended-format-for-a-research-protocol/

https://iaocr.com/finding-first-clinical-research-job/

https://jobs.newscientist.com/en-au/article/a-career-in-clinical-research/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/

St. Germain DC, Good MJ. 2017. Data management in clinical trials. In: Gallin JI, Ognibene FP, Lee Johnson L, editors. Principles and practice of clinical research. San Diego: Academic Press. p. 531-545. ISBN 978-0-12-849905-4

https://acrpnet.org/wp-content/uploads/dlm_uploads/2017/04/clinical-study-monitoring-competencies.pdf

https://www.clinicalleader.com/doc/starting-a-career-in-clinical-research-things-we-wish-we-knew-0001

https://www.proclinical.com/blogs/2021-9/how-to-get-a-job-as-a-clinical-research-associate-cra

https://acrpnet.org/2018/06/11/5-clinical-research-trends-emerge-at-acrp-2018/

https://www.collegechoice.net/sciences/clinical-research/best-masters-degrees/

https://acrpnet.org/certifications/cra-certification/

https://www.socra.org/certification/program-overview/

Pharmacovigilance: A Complete Guide to Pharmacovigilance and Drug Safety Training

The ultimate guide to clinical research monitoring.

Clinical Researcher

Navigating a Career as a Clinical Research Professional: Where to Begin?

Clinical Researcher June 9, 2020

Clinical Researcher—June 2020 (Volume 34, Issue 6)

PEER REVIEWED

Bridget Kesling, MACPR; Carolynn Jones, DNP, MSPH, RN, FAAN; Jessica Fritter, MACPR; Marjorie V. Neidecker, PhD, MEng, RN, CCRP

Those seeking an initial career in clinical research often ask how they can “get a start” in the field. Some clinical research professionals may not have heard about clinical research careers until they landed that first job. Individuals sometimes report that they have entered the field “accidentally” and were not previously prepared. Those trying to enter the clinical research field lament that it is hard to “get your foot in the door,” even for entry-level jobs and even if you have clinical research education. An understanding of how individuals enter the field can be beneficial to newcomers who are targeting clinical research as a future career path, including those novices who are in an academic program for clinical research professionals.

We designed a survey to solicit information from students and alumni of an online academic clinical research graduate program offered by a large public university. The purpose of the survey was to gain information about how individuals have entered the field of clinical research; to identify facilitators and barriers of entering the field, including advice from seasoned practitioners; and to share the collected data with individuals who wanted to better understand employment prospects in clinical research.

Core competencies established and adopted for clinical research professionals in recent years have informed their training and education curricula and serve as a basis for evaluating and progressing in the major roles associated with the clinical research enterprise.{1,2} Further, entire academic programs have emerged to provide degree options for clinical research,{3,4} and academic research sites are focusing on standardized job descriptions.

For instance, Duke University re-structured its multiple clinical research job descriptions to streamline job titles and progression pathways using a competency-based, tiered approach. This led to advancement pathways and impacted institutional turnover rates in relevant research-related positions.{5,6} Other large clinical research sites or contract research organizations (CROs) have structured their onboarding and training according to clinical research core competencies. Indeed, major professional organizations and U.S. National Institutes of Health initiatives have adopted the Joint Task Force for Clinical Trial Competency as the gold standard approach to organizing training and certification.{7,8}

Recent research has revealed that academic medical centers, which employ a large number of clinical research professionals, are suffering from high staff turnover rates in this arena, with issues such as uncertainty of the job, dissatisfaction with training, and unclear professional development and role progression pathways being reported as culprits in this turnover.{9} Further, CROs report a significant shortage of clinical research associate (CRA) personnel.{10} Therefore, addressing factors that would help novices gain initial jobs would address an important workforce gap.

This mixed-methods survey study was initiated by a student of a clinical research graduate program at a large Midwest university who wanted to know how to find her first job in clinical research. Current students and alumni of the graduate program were invited to participate in an internet-based survey in the fall semester of 2018 via e-mails sent through the program listservs of current and graduated students from the program’s lead faculty. After the initial e-mail, two reminders were sent to prospective participants.

The survey specifically targeted students or alumni who had worked in clinical research. We purposefully avoided those students with no previous clinical research work experience, since they would not be able to discuss their pathway into the field. We collected basic demographic information, student’s enrollment status, information about their first clinical research position (including how it was attained), and narrative information to describe their professional progression in clinical research. Additional information was solicited about professional organization membership and certification, and about the impact of graduate education on the acquisition of clinical research jobs and/or role progression.

The survey was designed so that all data gathered (from both objective responses and open-ended responses) were anonymous. The survey was designed using the internet survey instrument Research Electronic Data Capture (REDCap), which is a secure, web-based application designed to support data capture for research studies. REDCap provides an intuitive interface for validated data entry; audit trails for tracking data manipulation and export procedures; automated export procedures for seamless data downloads to common statistical packages; and procedures for importing data from external sources.{11}

Data were exported to Excel files and summary data were used to describe results. Three questions solicited open-ended responses about how individuals learned about clinical research career options, how they obtained their first job, and their advice to novices seeking their first job in clinical research. Qualitative methods were used to identify themes from text responses. The project was submitted to the university’s institutional review board and was classified as exempt from requiring board oversight.

A total of 215 survey invitations were sent out to 90 current students and 125 graduates. Five surveys were returned as undeliverable. A total of 48 surveys (22.9%) were completed. Because the survey was designed to collect information from those who were working or have worked in clinical research, those individuals (n=5) who reported (in the first question) that they had never worked in clinical research were eliminated. After those adjustments, the total number completed surveys was 43 (a 20.5% completion rate).

The median age of the participants was 27 (range 22 to 59). The majority of respondents (89%) reported being currently employed as clinical research professionals and 80% were working in clinical research at the time of graduate program entry. The remaining respondents had worked in clinical research in the past. Collectively, participants’ clinical research experience ranged from less than one to 27 years.

Research assistant (20.9%) and clinical research coordinator (16.3%) were the most common first clinical research roles reported. However, a wide range of job titles were also reported. When comparing entry-level job titles of participants to their current job title, 28 (74%) respondents reported a higher level job title currently, compared to 10 (26%) who still had the same job title.

Twenty-four (65%) respondents were currently working at an academic medical center, with the remaining working with community medical centers or private practices (n=3); site management organizations or CROs (n=2); pharmaceutical or device companies (n=4); or the federal government (n=1).

Three respondents (8%) indicated that their employer used individualized development plans to aid in planning for professional advancement. We also asked if their current employer provided opportunities for professional growth and advancement. Among academic medical center respondents, 16 (67%) indicated in the affirmative. Respondents also affirmed growth opportunities in other employment settings, with the exception of one respondent working in government and one respondent working in a community medical center.

Twenty-five respondents indicated membership to a professional association, and of those, 60% reported being certified by either the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

Open-Ended Responses

We asked three open-ended questions to gain personal perspectives of respondents about how they chose clinical research as a career, how they entered the field, and their advice for novices entering the profession. Participants typed narrative responses.

“Why did you decide to pursue a career in clinical research?”

This question was asked to find out how individuals made the decision to initially consider clinical research as a career. Only one person in the survey had exposure to clinical research as a career option in high school, and three learned about such career options as college undergraduates. One participant worked in clinical research as a transition to medical school, two as a transition to a doctoral degree program, and two with the desire to move from a bench (basic science) career to a clinical research career.

After college, individuals either happened across clinical research as a career “by accident” or through people they met. Some participants expressed that they found clinical research careers interesting (n=6) and provided an opportunity to contribute to patients or improvements in healthcare (n=7).

“How did you find out about your first job in clinical research?”

Qualitative responses were solicited to obtain information on how participants found their first jobs in clinical research. The major themes that were revealed are sorted in Figure 1.

Figure 1: How First Jobs in Clinical Research Were Found

Some reported finding their initial job through an institution’s job posting.

“I worked in the hospital in the clinical lab. I heard of the opening after I earned my bachelor’s and applied.”

Others reported finding about their clinical research position through the internet. Several did not know about clinical research roles before exploring a job posting.

“In reviewing jobs online, I noticed my BS degree fit the criteria to apply for a job in clinical research. I knew nothing about the field.”

“My friend recommended I look into jobs with a CRO because I wanted to transition out of a production laboratory.”

“I responded to an ad. I didn’t really know that research could be a profession though. I didn’t know anything about the field, principles, or daily activities.”

Some of the respondents reported moving into a permanent position after a role as an intern.

“My first clinical job came from an internship I did in my undergrad in basic sleep research. I thought I wanted to get into patient therapies, so I was able to transfer to addiction clinical trials from a basic science lab. And the clinical data management I did as an undergrad turned into a job after a few months.”

“I obtained a job directly from my graduate school practicum.”

“My research assistant internship [as an] undergrad provided some patient enrollment and consenting experience and led to a CRO position.”

Networking and referrals were other themes that respondents indicated had a direct impact on them finding initial employment in clinical research.

“I received a job opportunity (notice of an opening) through my e-mail from the graduate program.”

“I was a medical secretary for a physician who did research and he needed a full-time coordinator for a new study.”

“I was recommended by my manager at the time.”

“A friend had a similar position at the time. I was interested in learning more about the clinical research coordinator position.”

“What advice do you have for students and new graduates trying to enter their first role in clinical research?”

We found respondents (n=30) sorted into four distinct categories: 1) a general attitude/approach to job searching, 2) acquisition of knowledge/experience, 3) actions taken to get a position, and 4) personal attributes as a clinical research professional in their first job.

Respondents stressed the importance of flexibility and persistence (general attitude/approach) when seeking jobs. Moreover, 16 respondents stressed the importance of learning as much as they could about clinical research and gaining as much experience as they could in their jobs, encouraging them to ask a lot of questions. They also stressed a broader understanding of the clinical research enterprise, the impact that clinical research professional roles have on study participants and future patients, and the global nature of the enterprise.

“Apply for all research positions that sound interesting to you. Even if you don’t meet all the requirements, still apply.”

“Be persistent and flexible. Be willing to learn new skills and take on new responsibilities. This will help develop your own niche within a group/organization while creating opportunities for advancement.”

“Be flexible with salary requirements earlier in your career and push yourself to learn more [about the industry’s] standards [on] a global scale.”

“Be ever ready to adapt and change along with your projects, science, and policy. Never forget the journey the patients are on and that we are here to advance and support it.”

“Learning the big picture, how everything intertwines and works together, will really help you progress in the field.”

In addition to learning as much as one can about roles, skills, and the enterprise as a whole, advice was given to shadow or intern whenever possible—formally or through networking—and to be willing to start with a smaller company or with a lower position. The respondents stressed that novices entering the field will advance in their careers as they continue to gain knowledge and experience, and as they broaden their network of colleagues.

“Take the best opportunity available to you and work your way up, regardless [if it is] at clinical trial site or in industry.”

“Getting as much experience as possible is important; and learning about different career paths is important (i.e., not everyone wants or needs to be a coordinator, not everyone goes to graduate school to get a PhD, etc.).”

“(A graduate) program is beneficial as it provides an opportunity to learn the basics that would otherwise accompany a few years of entry-level work experience.”

“Never let an opportunity pass you up. Reach out directly to decision-makers via e-mail or telephone—don’t just rely on a job application website. Be willing to start at the bottom. Absolutely, and I cannot stress this enough, [you should] get experience at the site level, even if it’s just an internship or [as a] volunteer. I honestly feel that you need the site perspective to have success at the CRO or pharma level.”

Several personal behaviors were also stressed by respondents, such as knowing how to set boundaries, understanding how to demonstrate what they know, and ability to advocate for their progression. Themes such as doing a good job, communicating well, being a good team player, and sharing your passion also emerged.

“Be a team player, ask questions, and have a good attitude.”

“Be eager to share your passion and drive. Although you may lack clinical research experience, your knowledge and ambition can impress potential employers.”

“[A] HUGE thing is learning to sell yourself. Many people I work with at my current CRO have such excellent experience, and they are in low-level positions because they didn’t know how to negotiate/advocate for themselves as an employee.”

This mixed-methods study used purposeful sampling of students in an academic clinical research program to gain an understanding of how novices to the field find their initial jobs in the clinical research enterprise; how to transition to a clinical research career; and how to find opportunities for career advancement. There are multiple clinical research careers and employers (see Figure 2) available to individuals working in the clinical research enterprise.

Figure 2: Employers and Sample Careers

Despite the need for employees in the broad field of clinical research, finding a pathway to enter the field can be difficult for novices. The lack of knowledge about clinical research as a career option at the high school and college level points to an opportunity for broader inclusion of these careers in high school and undergraduate curricula, or as an option for guidance counselors to be aware of and share with students.

Because most clinical research jobs appear to require previous experience in order to gain entry, novices are often put into a “Catch-22” situation. However, once hired, upward mobility does exist, and was demonstrated in this survey. Mobility in clinical research careers (moving up and general turnover) may occur for a variety of reasons—usually to achieve a higher salary, to benefit from an improved work environment, or to thwart a perceived lack of progression opportunity.{9}

During COVID-19, there may be hiring freezes or furloughs of clinical research staff, but those personnel issues are predicted to be temporary. Burnout has also been reported as an issue among study coordinators, due to research study complexity and workload issues.{12} Moreover, the lack of individualized development planning revealed by our sample may indicate a unique workforce development need across roles of clinical research professionals.

This survey study is limited in that it is a small sample taken specifically from a narrow cohort of individuals who had obtained or were seeking a graduate degree in clinical research at a single institution. The study only surveyed those currently working in or who have a work history in clinical research. Moreover, the majority of respondents were employed at an academic medical center, which may not fully reflect the general population of clinical research professionals.

It was heartening to see the positive advancement in job titles for those individuals who had been employed in clinical research at program entry, compared to when they responded to the survey. However, the sample was too small to draw reliable correlations about job seeking or progression.

Although finding one’s first job in clinical research can be a lengthy and discouraging process, it is important to know that the opportunities are endless. Search in employment sites such as Indeed.com, but also search within job postings for targeted companies or research sites such as biopharmguy.com (see Table 1). Created a LinkedIn account and join groups and make connections. Participants in this study offered sound advice and tips for success in landing a job (see Figure 3).

Table 1: Sample Details from an Indeed.Com Job Search

Note: WCG = WIRB Copernicus Group

Figure 3: Twelve Tips for Finding Your First Job

• Seek out internships and volunteer opportunities
• Network, network, network
• Be flexible and persistent
• Learn as much as possible about clinical research
• Consider a degree in clinical research
• Ask a lot of questions of professionals working in the field
• Apply for all research positions that interest you, even if you think you are not qualified
• Be willing to learn new skills and take on new responsibilities
• Take the best opportunity available to you and work your way up
• Learn to sell yourself
• Sharpen communication (written and oral) and other soft skills
• Create an ePortfolio or LinkedIn account

Being willing to start at the ground level and working upwards was described as a positive approach because moving up does happen, and sometimes quickly. Also, learning soft skills in communication and networking were other suggested strategies. Gaining education in clinical research is one way to begin to acquire knowledge and applied skills and opportunities to network with experienced classmates who are currently working in the field.

Most individuals entering an academic program have found success in obtaining an initial job in clinical research, often before graduation. In fact, the student initiating the survey found a position in a CRO before graduation.

• Sonstein S, Seltzer J, Li R, Jones C, Silva H, Daemen E. 2014. Moving from compliance to competency: a harmonized core competency framework for the clinical research professional. Clinical Researcher 28(3):17–23. doi:10.14524/CR-14-00002R1.1. https://acrpnet.org/crjune2014/
• Sonstein S, Brouwer RN, Gluck W, et al. 2018. Leveling the joint task force core competencies for clinical research professionals. Therap Innov Reg Sci .
• Jones CT, Benner J, Jelinek K, et al. 2016. Academic preparation in clinical research: experience from the field. Clinical Researcher 30(6):32–7. doi:10.14524/CR-16-0020. https://acrpnet.org/2016/12/01/academic-preparation-in-clinical-research-experience-from-the-field/
• Jones CT, Gladson B, Butler J. 2015. Academic programs that produce clinical research professionals. DIA Global Forum 7:16–9.
• Brouwer RN, Deeter C, Hannah D, et al. 2017. Using competencies to transform clinical research job classifications. J Res Admin 48:11–25.
• Stroo M, Ashfaw K, Deeter C, et al. 2020. Impact of implementing a competency-based job framework for clinical research professionals on employee turnover. J Clin Transl Sci.
• Calvin-Naylor N, Jones C, Wartak M, et al. 2017. Education and training of clinical and translational study investigators and research coordinators: a competency-based approach. J Clin Transl Sci 1:16–25. doi:10.1017/cts.2016.2
• Development, Implementation and Assessment of Novel Training in Domain-based Competencies (DIAMOND). Center for Leading Innovation and Collaboration (CLIC). 2019. https://clic-ctsa.org/diamond
• Clinical Trials Talent Survey Report. 2018. http://www.appliedclinicaltrialsonline.com/node/351341/done?sid=15167
• Causey M. 2020. CRO workforce turnover hits new high. ACRP Blog . https://acrpnet.org/2020/01/08/cro-workforce-turnover-hits-new-high/
• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. 2009. Research electronic data capture (REDCap): a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 42:377–81.
• Gwede CK, Johnson DJ, Roberts C, Cantor AB. 2005. Burnout in clinical research coordinators in the United States. Oncol Nursing Forum 32:1123–30.

A portion of this work was supported by the OSU CCTS, CTSA Grant #UL01TT002733.

Bridget Kesling, MACPR, ( [email protected] ) is a Project Management Analyst with IQVIA in Durham, N.C.

Carolynn Jones, DNP, MSPH, RN, FAAN, ( [email protected] ) is an Associate Professor of Clinical Nursing at The Ohio State University College of Nursing, Co-Director of Workforce Development for the university’s Center for Clinical and Translational Science, and Director of the university’s Master of Clinical Research program.

Jessica Fritter, MACPR, ( [email protected] ) is a Clinical Research Administration Manager at Nationwide Children’s Hospital and an Instructor for the Master of Clinical Research program at The Ohio State University.

Marjorie V. Neidecker, PhD, MEng, RN, CCRP,  ( [email protected] ) is an Assistant Professor of Clinical Nursing at The Ohio State University Colleges of Nursing and Pharmacy.

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A Day in the Life of a Clinical Research Associate

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Every pill, cream, tonic, and capsule a pharmacist passes over the counter to an individual has taken a long journey from concept to the point of sale. In fact, many medications that do not require a prescription, such as those found in the allergy, cold, and flu aisle, also go through the same arduous process.

Before a drug can be prescribed and sold, it must be proven safe and effective. Pharmaceutical companies, universities, and health organizations put drugs through clinical trials or clinical study processes to obtain this proof. In the clinical trials world, the company that provides financial support to a research group selected to put the drug through clinical trials is known as a contract research organization or CRO. Primarily, CRO organizations offer financial aid for pharmaceutical development and biotechnology for agricultural and medical device industries.

In the case of pharmaceuticals, drugs that have not yet been approved for sale are administered to vetted participants in a controlled manner during a clinical trial. Clinical trials involve a great deal of documentation, analysis, observation, and organization. A team of professionals is engaged in administering a clinical trial, including a clinical research associate (CRA).

The CRA acts as a liaison between the study’s sponsor CRO (e.g., pharmaceutical company) and the clinics where the study occurs. Because the clinical trial results must be kept entirely transparent and not influenced by the sponsor’s interests, this is a critical role. Therefore, a successful CRA will be detail-oriented, highly educated, and communicate clearly with sponsors and clinical representatives.

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Work environment of clinical research associates.

A clinical research associate works both at clinical sites and sponsor locations. During a trial, the CRA conducts regular site visits—virtually and physically—to ensure good progress and record-keeping on the clinical site.

CRAs are often responsible for multiple trials at one time, meaning significant amounts of travel between these sites. Sometimes, a CRA may be assigned to a specific geographical region, limiting travel.

Clinical Team of a Clinical Research Associate

Typically, a clinical research associate needs to have direct contact with the participants involved in the study. However, CRAs must work in a collaborative environment, coming into frequent contact with the clinical team at the study site and the supervisors from the study sponsor. Thus, clinical research associates work in the middle of the chain of command, which begins at the top with:

• Contract research organization (CRO) or sponsor
• Principal investigator (PI)
• Clinical research associate (CRA)
• Clinical research coordinators (CRC)

In short, a CRA is focused more on data, accuracy, and quality control while a CRC collects data and interacts with patients. Dan Sfera , in his YouTube channel titled The Clinical Trials Guru, summarizes the CRA profession with this description: “CROs select various PIs across the country, and PIs make sure that sites follow good clinical practices and protocols. They ensure this by hiring CRAs who look at all the recorded data and do not interact with patients when they are completing a site visit.”

Typical Daily Responsibilities of Clinical Research Associates

The daily responsibilities of a CRA are mainly dependent on the stage of the trial they are supervising. As such, below is a breakdown of the typical duties of a CRA during the beginning, middle, and end of a clinical study.

Before a Study Begins

Every clinical study must take place in an appropriately equipped clinical location. The CRA plays a critical role in selecting a site for a clinical study and may even be asked to suggest sites based on their previous experiences. CRAs may also evaluate the applications of sites that self-select as eligible for a particular study. A pool of potential study sites is narrowed down by having sites complete and submit a feasibility survey.

When the pool of sites has been narrowed down, the clinical research associate conducts site selection visits with the chosen locations. During these visits, the CRA spends up to half a day confirming the validity of the feasibility study, meeting with the team (mainly the assigned coordinator), and observing the capabilities and equipment at the facility.

Upon completion of the site visit, the CRA compiles a report for the study sponsor and presents their findings and recommendations for proceeding with the study.

During a Study

Once a site has been selected, the CRA is now responsible for ensuring that the site knows the sponsor’s required protocol and is appropriately set up to conduct the study. In addition, the clinical research associate conducts site visits at regular intervals throughout the study to ensure that protocols are followed and data is effectively collected.

Depending on the study, CRAs may conduct in-person site visits as well as virtual visits. In recent years, the use of remote visit technology has allowed CRAs to review paperwork online, for instance, and reserve in-person visits for necessary personal interactions. During site visits, the CRA ensures that the study is always proceeding with good clinical practices. More details on the specific methods are available below.

Ultimately, since the CRA is a liaison, developing and maintaining positive relationships is an essential part of the job. During the trial, the CRA must communicate effectively and help the clinical staff appropriately to ensure the study progresses smoothly.

When a Study Ends

The CRA typically conducts a closeout visit after a study or when it becomes necessary to end a study—e.g. when enrollment is too low.

During the closeout visit, the CRA verifies that all paperwork is in order and that all obligations have been met on both sides. For example, the verification process may mean ensuring the trial drugs are returned or destroyed, completing and adequately filing all documentation, and compiling all information necessary to complete a final report for the study sponsor.

Required Skills & Knowledge of Clinical Research Associates

Based on the responsibilities outlined above, it should be no surprise that CRAs must have a knack for detail. Proper documentation, filing, and storage are all critical parts of the job description. It is up to the CRA to ensure that the sponsor and clinic understand their obligations at every point of the study. All policies and procedures are being followed to ensure successful data collection.

In addition to being detail-oriented, a good CRA also pays heed to the ethics of the position. For example, clinical trials and studies can have extensive consequences for the organizations that sponsor them, as well as for the trial participants, and eventually, for consumers at large. Therefore, CRAs act as vital monitors for ethical issues and should be able to stand up to any perceived transgressions.

Above all, it is essential that a CRA understands and can implement good clinical practices (GCP) successfully. The GCP guidelines are an internationally developed set of standards from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that details ethically and effectively conducting drug trials with human subjects.

The ICH topics are divided into four categories: quality, efficacy, safety, and multidisciplinary. CRAs can find the guidelines in more detail on the ICH website. The YouTube Channel, GCP Mindset , outlines the different roles and responsibilities of CRAs. In short, upholding the GCP standards is the most critical part of the CRA job, meaning that any CRA must be familiar with GCP and recognize and enforce these practices in a clinical setting.

Certification for Clinical Research Associates

While certification is not a legal requirement to work as a clinical research associate, it can provide an important differentiator when looking for employment or career advancement in many professions.

Two main bodies offer certification for CRAs: the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA).

Association of Clinical Research Professionals (ACRP) – Certified Clinical Research Associate (CCRA) Certification

To earn the Certified Clinical Research Associate (CCRA) credential from ACRP, applicants have two available pathways:

• Pathway 1 – Clinical research professionals with 3,000 hours of verifiable work experience are eligible to sit for the CCRA Exam.
• Pathway 2 – Clinical research professionals with 1,500 hours of verifiable work experience and a clinical research degree are eligible to sit for the CCRA Exam.

Applicants also have to submit proof of their current job description and resume and pass the CCRA exam. In addition, CCRAs must complete at least 24 hours of continuing education credits and be recertified every two years to maintain certification. Beyond the CCRA certification, ACRP also offers certifications for project managers, research coordinators, and principal investigators, and an umbrella certification for clinical professionals.

Society of Clinical Research Associates (SOCRA) – Certified Clinical Research Professional (CCRP) Certification

To earn the Certified Clinical Research Professional (CCRP) certification from SOCRA, applicants must either:

• Have at least two years of full-time experience as clinical research professionals or 3,500 hours of part-time experience in the past five years
• Have a degree in clinical research plus at least one year of full-time experience (or 1,750 hours part-time during the previous two years)
• Have a certificate in clinical research (undergraduate or graduate), a degree in science, health science, pharmacy, or a related field (associate’s or bachelor’s), plus at least one year of full-time experience (or 1,750 hours part-time during the previous two years)

Applicants must also pass the CCRP exam and be recertified every three years. Recertification requires 45 total hours of continuing education credits.

The critical difference between the SOCRA and ACRP certifications is that ACRP expressly certifies CRAs, while the SOCRA certification can apply to other clinical research professionals.

Matt Zbrog is a writer and researcher from Southern California. Since 2018, he’s written extensively about emerging issues in healthcare administration and public health, with a particular focus on progressive policies that empower communities and reduce health disparities. His work centers around detailed interviews with researchers, professors, and practitioners, as well as with subject matter experts from professional associations such as the American Health Care Association / National Center for Assisted Living (AHCA/NCAL) and the American College of Health Care Executives (ACHCA).

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• Program Overview

The SOCRA Certified Clinical Research Professional (CCRP) program is your gateway to excellence in clinical research. Elevate your career with our internationally recognized certification, tailored for professionals dedicated to upholding the highest standards in the field. Join a community committed to ethical practices, continuous learning, and advancing global health. 

The Society of Clinical Research Associates (SOCRA) established the Certification Program for Clinical Research Professionals in order to create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the clinical research community. Those individuals so recognized may use the "Certified Clinical Research Professional" or "CCRP ®  " designation.

Path to Certification

CCRP certification is awarded upon meeting two criteria: a successful written application and a passing CCRP examination score. The benefits of obtaining certification are numerous. It not only validates knowledge, skills, and abilities but also enhances credibility and peer recognition. Career advancement and increased earning potential become tangible outcomes, reflecting a commitment to standards, compliance, and integrity.

Scope and Standards of Practice 

The standards upon which this certification program is based have been set forth by SOCRA to promote recognition and continuing excellence in the ethical conduct of clinical trials.  It is the goal of SOCRA to encourage members, and assure the competency of certified members, in their knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance with the ICH Guidelines, the U.S. Code of Federal Regulations, and the ethical principles that guide clinical research. Members are expected to adhere to national, state, local and provincial regulations and to international guidelines published by the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and all applicable federal, state and local laws and policies.  

Standards of Practice include an understanding of and application of basic concepts of Good Clinical (Research) Practice, including:

• The Nuremberg Code
• The Belmont Report
• The Declaration of Helsinki
• 21 U.S. Code of Federal Regulations – Parts 11, 50, 56, 312, 812
• 45 U.S. Code of Federal Regulations - Part 46
• ICH Harmonised Guideline for Good Clinical Practice E6(R2), and
• ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)
• 42 CFR Part 11 (ClinicalTrials.gov) 

Certification Exam

The SOCRA Certification Examination is offered in two formats: paper and pencil (at SOCRA sponsored sites), and computer based (at Prometric testing centers or through Home Proctoring).

SOCRA Sponsored Sites: Paper and Pencil

• Hosted exams offered in various location throughout the US and Canada.
• Visit the paper and pencil exam schedule for dates and locations.
• A complete application must be received by the deadline date as stated on the examination schedule.
• Score reports mailed to you in 4-6 weeks after exam.

Computer Based Testing: Testing Centers and Remote Proctoring 

• Offered at Prometric testing centers throughout the world or through Home Proctoring 
• Click here  for a list of test centers.
• Allow 2-4 weeks for application processing. 
• Once application is approved, schedule exam at a testing center.  Exam sessions are available at least 6 weeks in advance.  
• Score reports received immediately upon completion of exam. 

Candidate Handbook

For more information, please view the  Candidate Handbook.

Certification

• CCRP Certification Quick Facts
• Definition of a Clinical Research Professional
• Certification Program Policies
• Removal of CCRP® Credential
• Verify Certification
• Exam Overview
• Candidate Eligibility
• Application and Fee
• Computer Based Testing Exams
• Paper and Pencil Exams
• Refunds, Rescheduling and Retesting
• SOCRA Sponsored Exam Schedule
• Preparing for the Exam
• Preparation Resources
• Examination Results
• Host an Exam at Your Site
• Apply Online
• Exam Schedule SOCRA Sponsored Sites
• Requirements for Maintaining Certification
• Continuing Education Requirements
• Descriptions of Acceptable CE
• CE Recordkeeping Requirements
• Request for SOCRA CE for Courses / Workshops
• Installment Plan Payment
• Renewal of Certification
• Recertification Audit
• Recertification Learning Module
• Accreditation

Summary of Certification Activities

11,145 CCRPs (as of 12/31/2022)

• 1,391 candidates took CCRP exam
• 73% passed CCRP exam
• 2,649 CCRPs recertified
• 946 candidates took CCRP exam
• 65% passed CCRP exam
• 2,783 CCRPs recertified
• 2,060 candidates took CCRP exam
• 70% passed CCRP exam
• 3,801 CCRPs recertified
• 1,980 candidates took CCRP exam
• 71% passed CCRP exam
• 3,188 CCRPs recertified
• 104 exam sites hosted
• 2,175 candidates took CCRP exam
• 2,491 CCRPs recertified
• 91 exam sites hosted
• 2,141 candidates took CCRP exam
• 2,421CCRPs recertified

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