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Regional CRA Monitor

Orange County Metro Area, CA

Posted: 01/29/2019 Job Type: Clinical Job Number: JN -022019-23585
One of our medical device clients is recruiting for a Regional CRA.

Summary:
  • Ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence
  • Validate investigational device accountability by tracking the history of investigational devices to the field sites and through final disposition
  • Verify trial data including maintaining appropriate regulatory documents
  • Ensure reconciliation of documents with the TMF
Qualifications:
  • BS in life sciences or related field with 5 years of monitoring experience
  • Medical device experience preferred
  • Knowledge of GCP, ICH, and FDA regulations
  • Experience with multiple electronic systems including Medidata RAVE and Veeva Vault
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