Clinical Research Associate/Senior Clinical Research Associate

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

Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.

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 xhyhwjd 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