Clinical Records Associate

IntegratedResourcesINC

Foster, CA, United States contract

Posted: August 24, 2017

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Quick Summary

Maintain a minimal understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records.

Required Skills

IT Regulations Security Maintenance File System Inventory Information Gathering Local storage Regulatory Compliance Electronic Systems

Job Description

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

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