Clinical Research Associate/Senior Clinical Research Associate Job at BioTalent, San Diego, CA

  • BioTalent
  • San Diego, CA

Job Description

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

Job Tags

Full time, Interim role

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