Job Details

  • Title: Clinical Records Associate
  • Code: RCI-GILD-06360
  • Location: Foster City California (CA) 94404
  • Posted Date: 05/16/2019
  • Duration: 6 Months
  • Status: Open
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  Job Description

  • Maintain an minimal understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records
  • Participate in continued security and maintenance of the Trial Master File (TMF) Room
  • Participate in offsite storage activates
  • Create and maintain study specific file structures for client's clinical, biometrics, and preclinical documents and file documents accordingly
  • Ensure record filing is kept up to date and is performed accurately
  • Perform an inventory review for incoming CRO clinical study files; receive, index, and file preclinical study records; responsible for offsite archival of documents; participate in periodic file room utilization reviews; file incoming documents and retrieve documentation from the TMFR upon request
  • May provide support during TMF-related regulatory agency and internal GCP inspections readiness
  • Assist in the development of electronic tracking/ filing systems