Clinical Research Coordinator Certification Requirements

Within the clinical research coordinator (CRC) role at Michigan Medicine, professional certification is a key component of career progression in the competency and training-based framework.  This policy sets forth the requirements of which positions must be held by a certified professional, timeline for certification, and financial support of the certification process.

A. Personnel in the following university market titles are required to hold one research certification as part of their position:

1. 103923 – Clinical Research Coordinator Associate
2. 103924 – Clinical Research Coordinator Intermediate
3. 103925 – Clinical Research Coordinator Senior
4. 103926 – Clinical Research Coordinator Lead
5. 103927 – Clinical Research Project Manager

Full, detailed job descriptions can be found navigating the Clinical Trials Support Office website.

B. To meet certification requirements, the following are accepted:

1. For positions that support FDA-regulated drug/device studies:
   1. Certified Clinical Research Coordinator (CRCC) from Association of Clinical Research Professionals (ACRP), or
   2. Certified Clinical Research Professional (CCRP) from Society of Clinical Research Associates (SoCRA)
2. For any positions that support non-FDA regulated studies (e.g., social, behavioral, epidemiological):
   1. Certification listed for FDA-regulated drug/device studies above (CRCC or CCRP), or
   2. NIH’s Good Clinical Practice for Social and Behavioral Research eLearning Course
3. Any proposed certification that is not named in this policy must be reviewed by the OoR EVDR, or designee, before being accepted:
   1. Example: Regulatory Affairs Certification (RAC) from Regulatory Affairs Professionals Society (RAPS) for those specializing in regulatory coordination only. Note: If position responsibilities change, specialized certification may become invalid.

C. Procedures

1. For hire into any position which requires certification:
   1. All current U-M employees must hold an appropriate certification prior to promotion/movement into a title which requires certification.
   2. External candidates hired into U-M for a title that requires certification must obtain certification within six months of date of hire.
      1. This expectation is to be included in the employment information from the unit prior to acceptance of position.
      2. Additionally, it must be communicated to the candidate that if the certification requirement is not met within six months of hire, the new employee will be moved to an appropriate job title that does not require certification.  This may impact compensation.
   3. Special Exception: CRC-Associate positions should be posted with an underfill of CRC-Technician. Any candidates that do not hold certification will be placed into the CRC-Technician title until certification is received, at which point they may be moved to CRC-Associate.
2. For individuals currently in positions requiring certification:
   1. Personnel who held valid certification that lapsed will be allowed to remain in their current position, but will not be eligible for placement into other institutional positions which require CRC certification until certification is renewed.
   2. Annual performance evaluations of personnel may be considered as “Not Met” if certification is not maintained.

D. Reimbursement to Personnel for Certification or Certification Maintenance

1. Will be the responsibility of the hiring individual (e.g., PI) or unit (e.g., department, division, center, institute, program, etc.) for the first two certification attempts.
2. Further information on reimbursement can be found in the CRC Reimbursement Process.

A. Association of Clinical Research Professionals
B. Society of Clinical Research Associates
C. NIH’s Good Clinical Practice for Social and Behavioral Research eLearning Course
D. MM Policy on Use of CRC Career Ladder
E. MM CRC Governance Board
F. MM Process on Reimbursement of CRC Certification

Questions on this policy may be directed to the Office of Research ([email protected])

Last Reviewed Date: September 1, 2024
Approval: Executive Vice Dean for Research