Clinical Records Associate

Clinical Records Associate

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Maintain an 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 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