National Occupational Standard for Clinical Research Coordinator

Definition of Occupation

The Clinical Research Coordinator (CRC) works at a clinical trial site as a member of a multi-disciplinary team that conducts clinical trials (studies). They execute the day-to-day activities in accordance with the study protocol developed by the trial sponsor and any applicable regulatory and ethical requirements, in order to ensure that all required data is collected and stored in a safe and secure manner, and that all required documentation and records are complete, accurate, and properly stored to ensure confidentiality.

CRCs recruit and enroll subjects for clinical trials. This involves ensuring that the subjects meet the eligibility requirements for the trial, as well as ensuring that that informed consent requirements are met. Informed consent involves a document (informed consent form) and a process for ensuring that the subject is fully informed as to the research nature of the study, its purpose and goals, how it will be conducted, any potential risks and/or side effects to the participant, what their rights and obligations are in relation to the trial, the process for withdrawing from the trial, the number of other subjects who are to be enrolled, and any other information required for the individual to make an educated decision to participate. This will also involve answering questions posed by the potential subject to ensure they fully understand before agreeing to participate. Once the trial is underway, the CRC is the main point of contact and liaison between research subjects and the trial site and ensures that the subjects adhere to the protocol throughout the trial.

During the trial, the CRC collaborates closely with both medical and administrative/scientific staff at the trial site, including the Principal Investigator, site manager(s), and other coordinators, as well as medical, pharmacy, and diagnostic departments and associated staff, in order to ensure that all stages of the trial, from initiation to completion and close-out, run smoothly and in
accordance with the trial protocol as well as all legal, ethical, and regulatory requirements. They participate in pre-trial feasibility surveys and serve as a point of contact with/between PI/CRO/Sponsor, as well as monitoring visits by CROs/Sponsors (during the trial), ensuring that all required documentation is complete and available to meet the requirements of the monitoring team.

They also are involved in coordinating site activities with respect to regulatory inspections and audits during the trial. In the case of academic institutions and investigator-initiated trials, CRCs may also be involved in assisting in/providing input to the preparation of grant applications related to clinical trials, and in the planning and budgeting of trials that may be conducted at their

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View Summary of NOS profile here: Clinical Research Coordinator – National Occupational Standard Summary