National Occupational Standard for Clinical Trial Assistant

Definition of Occupation

The Clinical Trials Assistant (CTA) works at a clinical trial site, usually under the supervision of Clinical Research Coordinator(s), assisting them as well as other health care professionals in the initiation, administration, coordination, and management of clinical research studies for the development of new drugs, clinical products (including medical devices), and treatment regimens.

The CTA may be involved in patient recruitment and enrollment, including interviewing potential trial candidates to ensure they meet the study criteria, ensuring the informed consent process is completed properly and documented, and maintaining study documentation and patients’ study charts related to the study.

During the trial, CTAs communicate with and observe patients, and in some cases (with appropriate training and supervision) may be involved in setting up for certain procedures such as collecting vital signs, drawing blood, collecting other samples, or dispensing and accounting for investigational products.

CTAs prepare and package samples for transport to labs and other diagnostic facilities, both internal and external to the site. They may also receive, inventory, and store investigational products and/or study-related materials which may involve liaison with other departments such as pharmacy, pathology department, and/or labs.

CTAs are involved in data collection and data entry related to the trial and assist the clinical trial research team in the preparation and maintenance of clinical trial documents for submission to the CRO and/or sponsor in accordance with International Council for Harmonisation (ICH) guidelines for Good Clinical Practice (GCP), local standard operating procedures (SOPs), local Research Ethics Boards (REB) requirements, and other regulatory and ethical requirements.

In some instances (particularly academia affiliated sites), CTAs assist in preparing grant proposals to obtain funding for clinical trials.

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