About this role

Company Description

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

Qualifications

Additional Information

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


Frequently Asked Questions

Is the salary disclosed for the Clinical Records Associate position at integratedresourcesinc?
The salary for this Clinical Records Associate role at integratedresourcesinc is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Clinical Records Associate position at integratedresourcesinc located?
This Clinical Records Associate role at integratedresourcesinc is based in CA, Foster, Foster, CA, United States, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Clinical Records Associate role at integratedresourcesinc full-time or part-time?
This is listed as a Contract position. It is posted as a Clinical Records Associate role at integratedresourcesinc.
How do I apply for the Clinical Records Associate position at integratedresourcesinc?
Click the "Apply Now" button on this page. You will be redirected to integratedresourcesinc's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Clinical Records Associate job at integratedresourcesinc posted?
This Clinical Records Associate position at integratedresourcesinc was posted on Aug 24, 2017. Apply as soon as possible โ€” early applications are often reviewed first.
Clinical Records Associate
integratedresourcesinc
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