Monitor and own the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. Coordinate all activities to set up and monitor a study. You will identify investigators and help prepare regulatory submissions.
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Perform all aspects of CRA duties from site selection, site initiation, through to site routine monitoring visits through to close-out visits and database lock incl. on-site, remote and risk-based monitoring. You will be embedded in our client's study team and have a dedicated ICON line manager to support you. Oversees all aspects of study site management to ensure high quality data.
The Clinical Research Associate (CRA) participates in the preparation and execution of pre-market to post-market clinical investigations, overseeing the progress of clinical investigations by conducting site qualification, initiation, interim monitoring and close out visits to clinical sites and monitoring clinical investigations in accordance with Good Clinical Practice/ISO 14155, and procedures set forth by RQM+ and sponsors.