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
Job details are sourced from the employer's original posting.
Open job postingAbout the company
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.