Clinical Records Associate

Clinical Records Associate

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

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 procedures 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.