Posted to MedZilla on 10/22/2017


ProClinical

United States, Clinical Records Associate - I CR_EF_13650-MZ


 
 

ProClinical is recruiting for an open position of Clinical Records Associate on a contract basis, housed in Foster City, CA.

Responsibilities

  • 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.

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 Eleni Farrell on (+1) 2679830134 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.


Please visit our website at www.proclinical.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.