Clinical Research Coordinator Certification Program Overviews

Get information on certification requirements for clinical research coordinators. Read about the associations that offer these certifications and learn about education, experience and testing requirements.

Essential Information

Certification is a requirement for most clinical research coordinator positions. Certification recognizes that a coordinator has met eligibility requirements for the job and has the necessary skills and knowledge for the position.

There is a certification specifically for coordinators, offered by the Association of Clinical Research Professionals, and a general certification for all non-physician clinical research professionals, including clinical research coordinators. The Society of Clinical Research Associates offers the general certification. Requirements for each type of certification vary, but generally combine education and experience. Applicants must pass a competency exam as well.

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Certified Clinical Research Coordinator (CCRC)

Founded in 1976, the Association of Clinical Research Professionals (ACRP) is now one of the principal networking and educational resources for clinical researchers across several medical industries, including medical devices, biotechnology and medicine. Recognizing the need for certification, ACRP offered its first Certified Clinical Research Coordinator exam in 1992.

Prerequisites for Exam Admission

There are three options for exam admission, all of which combine education and experience. The first option calls for two years of full-time experience or four years of part-time experience as a clinical research coordinator plus either an associate’s or bachelor’s degree or registered nurse licensure. The second option includes a high school diploma with practical nurse, vocational nurse, laboratory technician or medical assistant licensure, plus three years of full-time experience or six years of part-time experience as a clinical research coordinator. The third option calls for any education level plus a 1-year course in clinical research, as well as experience (levels vary by education).

Exam Content

The ACRP certification exam has questions related to the following areas:

• Study design and protocols
• Research site preparation
• Accountability for investigated products
• Diagnostic and laboratory procedures
• Safety planning and problem reporting
• Expectations and duties of the coordinator
• Study subject recruitment and screening
• Informed consent issues
• Documentation and report forms
• Funding issues

Maintaining Certification

Certification from the Association of Clinical Research Professionals is good for two years. It may be renewed by either taking a renewal examination or by completing 24 continuing education contact hours; 12 of those hours must pertain directly to clinical research. A recertification fee must also be paid.

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Certified Clinical Research Professional (CCRP)

Clinical research coordinators formerly fulfilled a variety of job descriptions and came from an array of educational backgrounds. The Society of Clinical Research Associates (SCRA) devised certification perimeters to establish a level of education, knowledge and experience that would be accepted internationally. Today, those who meet established perimeters are known as Certified Clinical Research Professionals. Certification is currently acknowledged by the entire community of medical research for clinical research positions such as consultant, researcher, investigator, instructor, administrator, research nurse or coordinator.

Prerequisites for Admission to the Exam

SCRA lists three categories, which make candidates eligible to take the exam. The first category requires that a person must have completed 3,500 hours of employment within the past five years (the equivalent of two years of full-time work). The second category states that the candidate must have an undergraduate or graduate certificate in clinical research and 1,750 hours of related employment from the past two years (the equivalent of one year of full-time experience). The third category is for applicants who have completed a minimum of 144 credit-hours at a college or university while earning a clinical research certificate at the undergraduate or graduate level. These applicants must also possess at least an associate’s degree in science, pharmacy, health science or a related field, as well as 1,750 hours of experience within the past two years (the equivalent of one year of full-time employment).

Exam Content

In addition to CCRC subject, topic areas covered in the CCRP exam include:

• Clinical trial sponsorship
• Retention of records
• Quality assurance
• Site visits and audits
• Regulations and review boards
• Ethics

Maintaining Certification

Certification must be renewed every three years. A certificate holder must pay a recertification fee and complete 45 hours of continuing education credits to take the recertification exam.

Employment Outlook and Salary Info

The U.S. Bureau of Labor Statistics (BLS) has no data specifically for clinical research coordinators. However, medical and clinical laboratory technologists and technicians have similar duties. The BLS estimates for 2010-2020 that technologists and technicians may have job growth rates of 11% and 15%, respectively. Medical and clinical laboratory technologists made a median annual wage of $57,580 in May 2012. In the same year, clinical laboratory technicians earned a median of $37,240.