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Clinical Records Associate

Position ID: DJM/ClinicalRecords
Location: San Mateo CA

Clinical Records Associate

 

My client is an International Pharmaceutical organization that has an excellent reputation. 

 

  • Maintain an understanding ofGCP,ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records.
  • Maintain a working knowledge of clinical, biometrics, and preclinical documents.
  • Participate in continued security and maintenance of the Trial Master File (TMF) Room.
  • Assist in the development and implementation of procedure s for the establishment, security, and maintenance of the Trial Master Files for clinical studies and for preclinical study records.
  • Assist in the development of Trial Master File SOPs.
  • Assist with the training of company and contract employees on theTMFSOPs.
  • Participate in the management of vendor relationships includingoffsitestorage.
  • Create and maintain study specific file structures for company 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 incomingCROclinical 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.
  • Ensure appropriate documentation completed to track archival of files.
  • May provide support duringTMF-related regulatory agency and internalGCP inspections.
  • Assist in the development of electronic tracking/ filing systems.

 

Westport One consistently ranks as one of the top 10 offices within the MRI Network system, which consists of more than 700 offices worldwide.

Our Contract Staffing division has been the National Office of the Year every year since 1995.  We are the Contract Staffing "industry leaders" working specifically on contract and permanent positions within all industries.  Key positions we fill are:  General Office, Receptionists, Administrative Assistants, Secretaries, Executive Assistants, Transcriptionists, Customer Service Representatives, Human Resource Assistants, Data Entry, Accounts Payable, Accounts Receivable, Payroll, Bookkeeper, Medical Assistants, Medical Billing, Front Office, Back Office, Legal Secretaries, and Paralegals.

 

Any inquiries relating to this ad will be kept confidential.

To learn more about our organization please visit us at 
www.westportone.com.

 

 To apply for this position, submit your resume by choosing one or more of the following:

1.)    ***CLICKING “APPLY NOW” ON THIS PAGE*** (PREFERRED)

 

2.)   Email your resume in WORD format to debbiem@westportone.com .  Please refer to job reference code DJM/ClinicalRecords in the subject line.

 

3.)   Fax resume with cover letter to:  314-991-9586.  Attention:  Debbie Maul.  Please refer to job reference code DJM/ClinicalRecords

 

NO CALLS PLEASE

 

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