Clinical Records Associate

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

• Gold Seal JCAHO Certified ™ for Health Care Staffing
• “INC 5 0 0 0 ’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)