Clinical Records Associate
Job Title: Clinical Records Associate - II
Location: Foster City, CA
Duration: 12 Months
Job Description:
- 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.
- Maintain a working knowledge of clinical, biometrics, and preclinical documents.
- Participate in continued security and maintenance of the Trial Master File (TMF) Room.
- Assist in the development and implementation of procedure s for the establishment, security, and maintenance of the Trial Master Files for clinical studies and for preclinical study records.
- Assist in the development of Trial Master File SOPs.
- Assist with the training of Client and contract employees on the TMF SOPs.
- Participate in the management of vendor relationships including offsite storage.
- Create and maintain study specific file structures for Client 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.
- Ensure appropriate documentation completed to track archival of files.
- May provide support during TMF-related regulatory agency and internal GCP inspections.
- Assist in the development of electronic tracking/ filing systems.
Kind Regards,
Sabanaaz Shaikh
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
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