Clinical trials test treatments that help improve and save lives. Clinical Research Associates perform various functions in ensuring clinical trials conform to and are performed in compliance with the protocol, regulatory and ethical guidelines and Good Clinical Practices (GCPs). CRAs monitor the conduct at investigative sites in the field (on-site) and/or remotely (in-house or centrally) by reviewing documents and data generated by the investigative site. CRAs often serve as the primary liaison between the sponsor (pharmaceutical companies) of the trial and the investigative site (doctors’ offices).*.
A CRA is responsible for the management of assigned clinical trials from study start to close out. Duties will include analysis of potential subject recruitment, investigator recruitment and selection, conducting site initiation meetings, assisting with the preparation of protocols, creating informed consent forms, electronic data capture (EDC) testing, organizing Institutional Review Board and/or electronic consent submissions with follow through to ensure successful outcomes, monitoring clinical data, trial master file, maintenance, and related deliverables.