Clinical Research Associate/Senior Clinical Research Associate

? Hiring: Clinical Research Associate (CRA), Medical Device | San Diego, CA

? 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