Clinical Research Coordinator Certification Requirements

Clinical Trials Support Office
Feb 23, 2023 12:00 pm

This Medical School Office of Research policy addresses the requirement for study team personnel in specific Clinical Research Coordinator (CRC) titles to hold a relevant certification.

  • Purpose

    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.

  • Policy

    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 this requirement, 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.

    C. Requirements

    1. During the implementation of the career ladder, personnel have until 12/31/2023 to complete certification; otherwise, new personnel must hold certification within six months of date of hire to the position; whichever is later.
      1. If certification requirement is not met in the time allotted, personnel must be moved to a job title that does not require certification.
      2. Allowed period for certification does not reset with department transfers.
    2. Once obtained, personnel who do not maintain their certification will be allowed to remain in their current position, but will not be eligible for promotion or other institutional positions which require CRC certification.

    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 attempts.* 
    2. Further information on reimbursement can be found in the CRC Reimbursement Process.

    *During transition to the CRC Career Ladder, individuals hired prior to July 1, 2023, are required to complete certification by December 31, 2023. Additionally, consult reimbursement process for interim financial handling of those hired prior to June 30, 2022.

  • References and Related Guidance

  • History and Approval

    Questions on this policy may be directed to the Office of Research (ummsresearch@umich.edu)

    Last edited: June 19, 2023
    Approval: Executive Vice Dean for Research


Email ummsresearch@umich.edu

Clinical Trials Support Office
1600 Huron Pkwy, Building 400, Ann Arbor, MI 48109

Edited by: dagi@umich.edu
Last updated: June 21, 2023, 8:45 AM