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.

Core Responsibilities and Daily Activities

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 (PI);
• Site manager(s) and other coordinators;
• Medical, pharmacy, and diagnostic departments and associated staff.

This collaboration is necessary 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.

Subject Recruitment and Informed Consent

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. This process covers:

• The study's purpose and goals;
• How the research 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.

This will also involve answering questions posed by the potential subject to ensure they fully understand before agreeing to participate.

Monitoring and Regulatory Compliance

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.

Summary of Key Coordinator Functions

• Trial Execution: Day-to-day activities, protocol adherence, and safe data storage.
• Communication: Main liaison between subjects, trial site, and external sponsors.
• Compliance: Ensuring all documentation meets legal, ethical, and regulatory requirements.