Clinical research coordinator

A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI).

Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston as:

The PI is responsible for the conduct of the trial, however, "it has been said that the CRC is the heart and soul of the research study and that, ultimately, it is the CRC who carries forward the research goals, thereby playing a significant role in the success of the research study. Most importantly, CRCs are often involved in essential duties that have been traditionally performed by the PI, such as conducting the informed consent process and ensuring compliance with the protocol." The CRC's primary responsibility, as with all clinical research professionals, is the protection of human subjects, but the CRC has many other responsibilities. Although not inclusive, some of the CRC responsibilities include preparing the Institutional Review Board submission, writing the informed consent document, working with the institutional official in contract negotiations, developing a detailed cost analysis, negotiating the budget with the Sponsor (i.e., pharmaceutical company or granting agency), subject recruitment, patient care, adverse event reporting, preparing the case report form (CRF), submitting CRFs and other data to the Sponsor as necessary and study close-out.

All research involving human subjects must be approved by an Institutional Review Board (IRB). Each IRB has protocol submission requirements, which typically involve an IRB application and informed consent document. A study cannot begin without IRB approval.

The IRB must approve informed consent prior to study initiation, and often the CRC is liaison between the IRB and the sponsor. The sponsor sets informed consent requirements, as does the IRB. Each local IRB must review and approve the informed consent, but the CRC is responsible for communication between the IRB and the sponsor. §46.116 of the Code of Federal Regulations outlines the basic elements of informed consent as a:

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