How Do You Become a Clinical Research Coordinator (CRC)?

A clinical research coordinator (CRC), sometimes called a clinical trial manager, plays an integral role in medical studies of all kinds. They typically work under the direction of the principal investigator (PI), who is in charge of designing, conducting, and managing the clinical trial from a high level. The CRC’s job is to support, facilitate, and organize daily clinical trial activities.

Clinical research coordinators also work in conjunction with the department, sponsor, and institution to guide them through compliance, finances, and personnel issues. In short, the CRC manages the day-to-day clinical operations activities, overseeing and executing delegated tasks to appropriate parties.

Key responsibilities of the CRC include the planning and managing the study, enrollment, maintenance, training initiatives, and maintaining compliance with federal, state, and institutional regulations. In addition, they carry out experiments, clinical research, and medical studies. They also engage directly with the trial participants as they screen them for eligibility, develop and implement recruitment strategies, and liaise with all teams throughout the trial. From evaluating research protocols to seeking approval from regulatory committees, CRCs have a broad reach within laboratories, medical centers, and research hospitals.

To secure a job as a CRC, professionals must have at least a four-year bachelor’s degree in a field such as medical technology, microbiology, or public health administration. However, some employers require an additional two-year master’s degree, particularly for management positions.

Typical courses to prepare for this career include biochemistry, biostatistics, healthcare management, mathematics, epidemiology, and human anatomy. Essential job skills include management and communications experience, multi-tasking, and interpersonal skills. In addition, students may have to take and pass a licensing exam to become clinical research coordinators. (See more on certification below)

Additionally, students may consider internships or entry-level jobs working as lab technicians or healthcare workers to get familiar with the typical working environment.

As the medical industry grows, college graduates, especially those with a master’s in clinical research, will be on the front lines of research and development. As a result, students have various career prospects in front of them with an education in clinical research, from medical scientists to natural sciences managers.

Continue reading for a comprehensive guide on achieving the various levels of a clinical research career, followed by helpful resources that can guide students and professionals as they navigate the process.

Becoming a clinical research coordinator takes many steps, and varied career pathways are available. Below are some of the primary steps to becoming a CRC at different phases of educational achievements.

Step 1: Graduate from high school (four years).

Preparation for a career in clinical research coordination should begin with high school courses in chemistry, biology, physics, math, and communications which develop foundational knowledge for college-level coursework.

Step 2: Obtain a bachelor’s degree (four years).

When perusing colleges and universities, students should focus on those offering bachelor of science degrees in health sciences in clinical research administration. Students should dedicate at least four years of full-time work to this degree. These programs generally provide clinical research professionals with the tools to develop medicines and conduct trials and studies. In addition, on-campus and online programs focus on critical administrative and scientific methods regarding clinical research and guidelines to protect human subjects.

For example, George Washington University in Washington, DC offers a robust online program geared toward working health sciences and clinical research professionals looking to advance in their careers. Typical courses for a bachelor’s of science in this field include research and writing for health sciences, bioethics, healthcare in literature, informatics in the health sciences, biostatistics, healthcare law and regulation, basics of clinical research, health science management, and disease prevention and health promotion concepts.

The College of Public Health at Kent State University in Kent, Ohio, offers a bachelor of science in public health (BSPH) in clinical trials research. Offered on-campus and online, this program prepares students for work as clinical trial researchers and managers.

The program emphasizes epidemiology and health research. Required classes include clinical epidemiology basics, clinical trial management, scientific writing for clinical research, and an internship in clinical research. Graduates from this program work for contract research organizations, pharmaceutical companies, hospitals, medical schools, universities, and insurance companies.

A bachelor’s degree can lead to an entry-level position in a clinical organization or institution. It can also help existing clinicians advance within their current jobs. Students wishing to open up even more opportunities for responsibility and salary are encouraged to pursue professional experience and additional education.

Step 3: Gain work experience as a clinical research professional (at least one year).

At this stage, it’s advisable to earn at least one year of full-time experience working in a clinical research capacity. This is a typical requirement to qualify for national certification.

Step 4a: Obtain a graduate certificate (optional, one year).

Students can earn an online graduate certificate in clinical research administration. George Washington University offers an 18-credit graduate certificate to strengthen career prospects while helping students hone their management skills for clinical research administration. Students can typically transfer credits earned in certificate programs into a master’s program within the same institution.

Arizona State University also offers a 15-credit online graduate certificate in clinical research management designed for nurses, physicians, and other healthcare professionals. Graduates are prepared for careers in many professions, from clinical research coordination and biostatistics to genetics and environmental studies.

Students can explore concentrations in scientific concepts, research design, participant safety considerations, medicines development, study and site management, data management and informatics, leadership and professionalism, and communication and teamwork. In addition, this degree offers an intense concentration in clinical research, financial and business practices, ethical research, and management skills related to drug and medical device trials.

Step 4b: Get a master of science in clinical research management (optional, two years).

Obtaining a master’s degree can increase one’s salary prospects and responsibilities within the field. For example, ASU’s master’s in clinical research management offers an online, 33-semester-hour program. A six-semester-hour clinical research project is also required.

Typical courses include clinical research monitoring and fundamentals of regulatory affairs. By the program’s conclusion, students are prepared to seek careers as clinical research coordinators and clinical data managers, social science research assistants, and clinical lab techs.

Step 5: Get certified (timeline varies).

Professionals in this field are strongly recommended to be certified in clinical research. For example, the Society of Clinical Research Associates (SOCRA) offers an internationally accepted certification for professionals to be recognized as Certified Clinical Research Professionals (CCRP®s).

Students must pass an exam to get their certification. The exam schedule is varied and offers time slots at locations all over the United States. There are three distinct pathways to be eligible for this exam. First, applicants must fall into one of the following categories:

• Category 1– Has two years of full-time experience as a clinical research professional (or 3,500 hours part-time during the previous five years)
• Category 2 – Holds a degree in clinical research (associate, bachelor’s, or master’s) and at least one year of full-time experience as a clinical research professional (or 1,750 hours part-time during the previous two years)
• Category 3 – Holds an undergraduate or graduate certificate in clinical research (at least 12 semester-hours or 144 credits); an associate or bachelor’s degree in a scientific (or related) field; and at least one year of full-time experience as a clinical research professional (or 1,750 hours part-time during the previous two years)

Alternatively, students can seek certification from the Association of Clinical Research Professionals, called the ACRP-CP®. There are three levels of certification: clinical research associate (CCRA), clinical research coordinator (CCRC), and principal investigator (CPI). In addition, ACRP offers prep courses to help students prepare for each test.

To be eligible for the CCRA or CCRC certification exam, candidates have two available pathways:

• Pathway 1 – Clinical research professionals with 3,000 hours of verifiable work experience are eligible to sit for the CCRC or 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 CCRC or the CCRA Exam.

Please note that there may be substitutions for hours of qualifying work experience and that “designated duties” may differ by the desired certification. Students can learn more about the ACRP’s exam, schedule, application, and eligibility requirements on the organization’s website.

Additionally, the Certified Clinical Research Professionals Society offers four clinical research certification training courses. The content is delivered on-demand to accommodate people’s busy schedules without compromising the highest-quality professional standards.

Here are the four levels of certification and their eligibility requirements:

• Clinical Research Assistant (CRC) – No experience/certification
• Assistant CRC – Some experience or CRC certification
• Associate CRC I/II – Two years experience or CRC certification
• Senior CRC, CRC I/II – Three to six years of experience with advanced CRC certification

The CRC Course is where all new applicants begin. This entry-level program is triple-accredited, and the curriculum features comprehensive content with real-world examples and hands-on training experiences. In addition, every module includes checklists, templates, and instant pacing. The course costs $150, is updated bi-annually, and fully complies with FDA regulations such as human subjects protection and HIPAA (health insurance portability and accountability act).

Another certification to consider is the CRS Certified Clinical Research Coordinator credential offered by the Clinical Research Society. All applicants must submit a detailed CV/resume and a job description upon application. There are six eligibility pathways for this certification:

• Category 1 – Bachelor’s degree, master’s degree, or registered nurse (RN) with 2,000 hours of work experience performing core CRC tasks defined by the Clinical Research Society.
• Category 2 – Bachelor’s degree, master’s degree, or registered nurse (RN) and completion of a clinical research program with more than 150 hours of clinical research; 1,400 hours of work experience performing core CRC tasks defined by the Clinical Research Society.
• Category 3 – Associate’s degree with 2,800 hours of work experience performing core CRC tasks defined by the Clinical Research Society.
• Category 4 – Associate’s degree and completion of a clinical research program with more than 150 hours of clinical research; 1,400 hours of work experience performing core CRC tasks defined by the Clinical Research Society.
• Category 5 – High school diploma or LPN/LVN/medical assistant/research assistant with 2,800 hours of work experience performing core CRC tasks defined by the Clinical Research Society.
• Category 6 – High school diploma or LPN/LVN/medical assistant/research assistant and completion of a clinical research program with more than 150 hours of clinical research; 1,400 hours of work experience performing core CRC tasks defined by the Clinical Research Society.

Upon acceptance, applicants can choose to become Clinical Research Society members with access to a 40-hours structured CRC training and certification program. The ten areas covered include:

• Introduction
• Drug development
• Ethics in drug development
• Regulations in clinical research
• Roles & responsibilities
• Essential documents
• Study start-up
• Study site management & closeout
• Safety reporting
• Role of quality assurance and data management

For CRS members, the training and certification fee is $130 and $175-$235 for non-members depending on the nationality. The credential is good for two years and can be maintained by completing 24 documented hours of continuing research education (CRE) or continuing professional engagement (CPE).

The following list of professional organizations can assist students and professionals in seeking a career in clinical research.

• National Institutes of Health – The National Institutes of Health offers a free course titled “Introductions and Principles and Practice of Clinical Research (IPPCR).” This clinical research coordinator training course focuses on the ethical issues involved in human subject research. It provides an overview of scientific methodologies, principles, and practices required for patient-oriented research. The course is designed for medical and public health professionals or anyone aspiring to join a clinical research career. Topics include ethical issues, biostatistical methods, study design, protocol preparation, patient monitoring, and quality assurance.
• Harvard Catalyst Clinical Research Center – The HCCRC offers information for research coordinators. These resources address professional development, training and certifications, helpful tools, and core competencies for the clinical research professional.
• International Association of Clinical Research Nurses – The IACRN is a professional nursing organization that defines, validates, and advances clinical research nursing while supporting the professional development of registered nurses who work with clinical research participants.
• Association of Clinical Research Professionals – The ACRP sets the standards for competence in clinical research. The organization is based in Washington, DC and boasts 13,000 members supporting professionals with the membership, training, and certification programs they need to maintain career excellence.
• Oregon Health & Science University – OHSU’s Oregon Clinical and Translational Research Institute’s mission is “To enhance the efficiency and quality of rigorously translating research ideas into impact.” This organization provides various helpful resources and webinars to guide students as they gather the information necessary to pursue a career in clinical research coordination.

Matt Zbrog

Writer

Matt Zbrog is a writer and freelancer who has been living abroad since 2016. His nonfiction has been published by Euromaidan Press, Cirrus Gallery, and Our Thursday. Both his writing and his experience abroad are shaped by seeking out alternative lifestyles and counterculture movements, especially in developing nations. You can follow his travels through Eastern Europe and Central Asia on Instagram at @weirdviewmirror. He’s recently finished his second novel, and is in no hurry to publish it.