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Clinical Records Associate - II
Ref No.: 18-04231
Location: Foster City, California
Start Date / End Date: 04/30/2018 to 04/29/2019
Must meet all requirements for Clinical Records Assistant position and have demonstrated proficiency in all relevant areas.Maintain an understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records and bioanalytical documentation.Participate in continued security and maintenance of the Trial Master File (TMF) Room and the GLP Archive room. Assist in the development and implementation of procedures for the establishment, security, and maintenance of the Trial Master Files for clinical studies and for preclinical study records and bioanalytical documentation.Perform an inventory review for incoming CRO clinical study filesReceive, index, and file preclinical study records and bioanalytical documentation.Participate in periodic file room utilization reviews.File incoming documents and retrieve documentation from the TMF Room and the GLP Archive room upon request.Assist in the development of Trial Master File and non clinical Archive Index SOPs.Assist with the training of Client and contract employees on the TMF and non clinical Archive Index SOPs. Create and maintain study specific file structures for Client clinical (TMF), biometrics preclinical and bioanalytical documentation and file documents accordingly.Ensure record filing is kept up to date and is performed accurately.Ensure appropriate documentation completed to track archival of files.Basic bioanalytical report formatting and maintenance in conjunction with Document processing.May provide support during regulatory agency and internal GCP and GLP inspections.Assist in the development of electronic tracking/ filing systems