CRA (Clinical Research Associates)

Clinical research associates (CRA), also known as Clinical Trial Monitors, are health care professionals that act as the liaison between the sponsor and the clinical site, ensuring compliance with sponsor and/or regulatory requirements.

CRAs may be employed by pharmaceutical companies, government agencies, CROs, or research institutes. They are tasked with communicating with the CRCs, auditing the data and documentation from the research sites to ensure accuracy and completeness, and evaluating the site’s compliance with the procedures outlined by the protocol. They also ensure the safety and welfare of trial subjects.

The policies of Good Clinical Practice govern the responsibilities of CRAs, and they must have working knowledge of the same.

Source: NIDCR. (2020, July). NIDCR Clinical Monitoring Guidelines. NIH.