Job Detail


Clinical Records Associate - I


Foster City, CA

Posted on Sep 11, 2017

Job Description:
  • Maintain a minimal understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and pre-clinical 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 Gilead clinical, biometrics, and pre-clinical 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 pre-clinical 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.

GDH Consulting, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran’s status or any other category protected by law. In addition to federal law requirements, GDH Consulting, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities and/or employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, benefits and training.