Clinical Records Associate - II in Foster City, CA at Apex Life Sciences

Date Posted: 7/17/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    7/17/2018
  • Job ID:
    840586

Job Description


Description:
Maintain an understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation and preclinical study records and bioanalytical documentation.
Participate in continued security and maintenance of the Trial Master File (TMF) Room and the GLP Archive room. 
Assist in the development and implementation of procedures for the establishment, security, and maintenance of the Trial Master Files for clinical studies and for preclinical study records and bioanalytical documentation.
Perform an inventory review for incoming CRO clinical study files
Receive, index, and file preclinical study records and bioanalytical documentation.
Participate in periodic file room utilization reviews.
File incoming documents and retrieve documentation from the TMF Room and the GLP Archive room upon request.
Assist in the development of Trial Master File and non-clinical Archive Index SOPs.
Assist with the training and contract employees on the TMF and non-clinical Archive Index SOPs.
Create and maintain study specific file structures for clinical (TMF), biometrics preclinical and bioanalytical documentation and file documents accordingly.
Ensure record filing is kept up to date and is performed accurately.
Ensure appropriate documentation completed to track archival of files.
Basic bioanalytical report formatting and maintenance in conjunction with Document processing.
May provide support during regulatory agency and internal GCP and GLP inspections.
Assist in the development of electronic tracking/ filing systems
 

Experience:
BA/BS degree preferred 
5+ years of experience 

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.