Clinical Records Associate

2 weeks ago


Saanich, Canada Integrated Resources Inc. Full time
* 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 activities.
* 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.

Additional Information

Rupalim Dutta
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE
GSA - Schedule 66
GSA - Schedule 621I

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