Clinical Records Associate

Proclinical is currently seeking a Clinical Records Associate for a biotechnology company located in Foster City, CA. Successful candidate will be responsible for maintaining a minimal understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records.

Job Responsibilities:

• Create and maintain study specific file structures for clinical, biometrics, and preclinical documents and file documents accordingly.
• Ensure record filing is kept up to date and is performed accurately.
• Participate in continued security and maintenance of the Trial Master File (TMF) Room.
• Participate in offsite storage activates.
• 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.
• Provide support during TMF-related regulatory agency and internal GCP inspections readiness.
• Assist in the development of electronic tracking/ filing systems.

Skills and Requirements:

• BA/BS required.
• 0-2 years' experience in clinical research environment.
• Experience with TMF preferred.
• Experience with Microsoft Office Suite.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Catherine Nguyen at (+1) 215-531-5643 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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