Clinical Research Associate
BioTalent
Clinical Research Associate (CRA), Medical DeviceBased fully onsite in San Diego CA with some domestic clinical site travel I'm partnering with a fast-moving, commercial stage medical device company running investigational device studies. The research here moves toward commercialization and patient impact rather than sitting in a lab for decades.What you'll do:Monitor multiple investigational device studies, both company-sponsored and investigator-initiatedRun site qualification, initiation, interim monitoring and close-out visitsPerform source data verification and manage queries, deviations and AE/device deficiency reportingKeep sites compliant with GCP, ISO 14155 and 21 CFR 812, and ready for inspectionServe as the primary sponsor contact for assigned sitesWhat you'll need:Bachelor's degree in life sciences, nursing or a related field2+ years in clinical research, including on-site monitoring (senior coordinators are welcome)Investigational device experienceHands-on experience with EDC, SDV and IRB/IDE documentationSelf-starter who works independently under competing deadlines
Vacancy posted 1 day ago
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