A clinical research coordinator (CRC) is a professional member of the research team, often considered the principal investigator’s “right hand.” Although the PI is ultimately responsible for the investigation, an experienced CRC with a working knowledge of good clinical practice, institutional policies and procedures, and the regulatory requirements necessary for human subject research can be an invaluable part of the clinical research study team. The CRC may also serve as a liaison between the PI, the Institutional Review Board (IRB), the sponsoring agency or pharmaceutical company, the academic institution, and study participants. The overall goal of the CRC is to ensure the safety, quality, and timely completion of a clinical research study.
How do I know if I need a CRC?
Conventional wisdom has it that if you think you need a CRC, then you need one. A CRC is not required in a clinical research investigation, and the PI often performs all the duties of a CRC; nevertheless, in many cases, a CRC can be critical to the success or failure of a clinical research study because of the added expertise that a CRC brings to the project. In general, the more complex the study design, the more collaborators or institutions involved, the longer the trial, and the greater the number of study participants, the better off a research team will be with a CRC.
What does a CRC do?
A CRC can assist with every stage of the research study, from preparing an IRB submission to study closeout documentation. Specific responsibilities of a CRC may include
- Study initiation—maintaining close communication between the IRB and the sponsor, preparing the study protocol for IRB submission, and writing the informed consent documentation
- Subject recruitment—coordinating the recruitment of participants for a study through the informed consent process
- Trial operations—coordinating participant visits to the clinical trial site and conducting the trial according to protocol. In conjunction with the PI, the CRC can also ensure that study participants receive appropriate medical evaluation, care, and referral when indicated and report any adverse events to the IRB and sponsor.
- Study closeout—collecting, storing, and reporting data to the sponsor in
accordance with the trial protocol and regulatory requirements
At the end of the study, the CRC can also complete IRB study close documentation.
How much does a CRC cost?
A CRC typically earns between $15 and $30 an hour, depending on the research location as well as the individual’s credentials and experience. Because this expense is usually paid from the grant, the CRC’s salary should be included in the grant application.
Where can I find a CRC?
The Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SoCRA) are two national organizations that provide certification and training for CRCs. The University of Pittsburgh Office of Clinical Research, Health Sciences maintains a list of CRCs at the University of Pittsburgh, UPMC, and affiliated institutions through a Research Coordinator Registry.
