Clinical Records Associate
Company Description
Job Description
Job Description:
* Maintain a 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 Gilead 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
Qualifications
Additional Information
Rupalim Dutta
Clinical Recruiter
Integrated Resources , Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE | GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # 650-399-0896
LinkedIn: www.linkedin.com/in/rupalim-dutta
Source: the employer's careers page. Last checked 2026-10-08. Posted 2026-10-01.
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