Required Use of Clinical Research Coordinator Career Ladder

Michigan Medicine has established a defined professional career ladder for Clinical Research Coordinators (CRC) that align the competencies, experience, and education/training necessary to meet the growing demands and rigor of this role. CRCs are a critical resource to conducting high-quality clinical trials and contribute to the research stature of Michigan Medicine. Establishment of the defined roles and requirements in the career ladder recognizes the concomitant increase in complexity of work and regulations that govern clinical research. 

Michigan Medicine staff employees are required to hold a university market title in the Clinical Research Coordinator (CRC) series if they are study team personnel performing coordination functions* in either scenario below:

• Any project in the staff member’s portfolio is an NIH-defined Clinical Trial that is FDA-regulated or has a risk level of minor, moderate, or high as indicated in the IRB approval letter.
• The staff member’s job duties include >60% effort involving participant interaction and any project in the staff member’s portfolio is FDA-regulated or has a risk level of minor, moderate, or high as indicated in the IRB approval letter.

* This includes clinical coordinating personnel who oversee and set direction of coordination activities or provide guidance on functional execution of activities in any multi-site study.

Use of the CRC title is optional for Michigan Medicine staff employees performing coordination functions or having participant interactions on clinical research studies not meeting the criteria above.

Use of the CRC title series is not required or recommended for those who do not perform clinical research study coordination functions.

Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. (source NIH, reviewed 2/2023)

Interventional Clinical Trial: A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. (source ClinicalTrials.gov, reviewed 2/2023)
 
Clinical Research Studies: A type of study that involves participant interaction but does not meet NIH definition of clinical trials. This may include but is not limited to: survey studies, biomarker studies, clinical/behavioral observational studies in which participants are enrolled, data and/or samples are collected and analyzed.  

Clinical Coordinating Personnel: An individual or group of individuals responsible for oversight and management of the conduct of a multi-center study at collaborating institutions. Activities include, but are not limited to: directing site coordination; responding with guidance on study conduct and safety; performing quality assurance and monitoring; and providing central regulatory management or site regulatory oversight. This excludes those primarily responsible for database creation or data analysis.

A. Michigan Medicine study team personnel performing coordination functions that include participant interaction for clinical trials are required to hold a university market title in the Clinical Research Coordinator (CRC) series:

1. 103921 – Clinical Research Assistant
2. 103922 – Clinical Research Technician
3. 103923 – Clinical Research Coordinator Associate
4. 103924 – Clinical Research Coordinator Intermediate
5. 103925 – Clinical Research Coordinator Senior
6. 103926 – Clinical Research Coordinator Lead
7. 103927 – Clinical Research Project Manager

A view of the detailed individual job descriptions, job comparison grid, and job posting templates can be found by navigating the Clinical Trials Support Office website.

B. The Clinical Research Coordinator series is maintained by the Michigan Medicine Office of Research (MM OoR) in partnership with Michigan Medicine Human Resources (MMHR).

1. The series will be reviewed from time to time to ensure roles are current with market and professional standards. 
2. MM OoR, at the direction of the Executive Vice Dean for Research (EVDR), will establish a Clinical Research Coordinator (CRC) Governance Board to oversee application of the policy.
3. Process requirements, approved by the EVDR and MMHR, will outline specific human resources (HR) practices related to this career ladder.

C. Hiring

1. All positions named in this policy are required to use the approved job posting templates to ensure alignment with job descriptions.
2. In addition to standard HR procedures, for positions or candidates of CRC-Senior, CRC-Lead, or CRC-Project Manager, MM OoR requires:
   1. New positions to be reviewed and approved by the CRC Govenance Board for appropriate title level based on stated job responsibilities, prior to job posting.  
   2. Candidates for positions to be reviewed and approved by the CRC Governance Board for qualifications consistent with requirements in the proposed title, prior to offer letter. 
3. Classification of a position or placement of candidate into titles of Clinical Research Assistant through CRC-Intermediate do not require review by the CRC Governance Board.  MMHR will follow any MM OoR-provided guidance to ensure positions and candidates meet qualifications.

D. Promotions

1. All positions named in this policy will be eligible for the promotion review process twice a year, aligned with annual valuations and mid-year valuations.
2. In addition to standard HR procedures, for positions or candidates of CRC-Senior, CRC-Lead, or CRC-Project Manager, MM OoR requires:
   1. Classification of a position be reviewed and approved by the CRC Governance Board for appropriate title level based on stated job responsibilities, prior to promotion.
   2. Candidates for positions to be reviewed by the CRC Governance Board for qualifications consistent with requirements in the proposed title, prior to promotion.
3. Classification of a position or candidate into titles of Clinical Research Assistant through CRC-Intermediate do not require review by the CRC Governance Board.  MMHR will follow any MM OoR provided guidance to ensure positions and candidates meet qualifications.

E. Governance of the Series

1. The MM OoR EVDR, or delegate as assigned, will work in strong partnership with MMHR to ensure compliance with all laws, regulations, and policies.
2. The MM OoR EVDR may elect to establish additional governing boards, task forces, or other groups to inform the decisions related to the career ladder series.

F. Compliance

1. In an effort to maintain the integrity of the CRC series, the MM OoR, or their delegate, will perform an audit no less than annually to ensure compliance.
2. Departments will work with the CRC Governance Board to rectify any noncompliance within one (1) month of notification.
    

A.    Clinical Trials Support Office
B.    UMMS Open Position Request Form
C.    UM Position Description Form
D.    MM Policy on Certification Requirements in the CRC Series
E.    MM Clinical Research Coordinator Governance Board
F.    Michigan Medicine HR Solution Center
 

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

Last edited: February 23, 2023
Approval: Executive Vice Dean for Research