Clinical Research Associate
BioTalent
Clinical Research Associate (CRA), Medical Device
Based 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-initiated
- Run site qualification, initiation, interim monitoring and close-out visits
- Perform source data verification and manage queries, deviations and AE/device deficiency reporting
- Keep sites compliant with GCP, ISO 14155 and 21 CFR 812, and ready for inspection
- Serve as the primary sponsor contact for assigned sites
What you'll need:
- Bachelor's degree in life sciences, nursing or a related field
- 2+ years in clinical research, including on-site monitoring (senior coordinators are welcome)
- Investigational device experience
- Hands-on experience with EDC, SDV and IRB/IDE documentation
- Self-starter who works independently under competing deadlines
Vacancy posted 10 hours ago
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