Clinical Records Associate

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 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