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Regulatory Document Associate / TMF - United States  

Company managed [?] Still accepting applications
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Posted on : 03 May 2017

Project Description

Celerion, a leading global contract research organization, seeks a Regulatory Document Associate / TMF  to join our Regulatory Affairs Team. The successful candidate will have experience in clinical research and document management.

This position will be responsible for the preparation and the completeness of the Trial Master Files (TMF) for internal and external studies. The position will also be accountable for proactively researching and maintaining an understanding of the regulations in regards to essential documents in order to proactively implement processes and identify electronic solutions for the TMF process.

Essential Functions:
  • Create and maintain the TMF file index and appropriate files according to the regulations and client-specific guidelines.
  • Communicate directly with the Sponsors, Project Manager, monitors, sites and other study contacts to ensure timely receipt of the required TMF documents.
  • Negotiate a TMF file structure with the client that meets Sponsor and Celerion’s SOPs and regulatory requirments.
  • Establish timelines with the Sponsor and Project Management for the return of completed TMF files.
  • Create and maintain an electronic TMF file structure as applicable for internal and external access and within the regulatory guidance documents requirements according to the client specific guidelines and study criteria.
  • Proactively maintain an understanding of the regulations including current best practice guidelines for TMFs and eTMFs.
  • Identify the appropriate QC checks of the essential documents and implement the checks Access and implement data solutions for creation and maintaining of eTMFs.
  • Participate in process improvement projects to gain efficiencies with Investigator Site File handling and on line portal usage.
  • May maintain a disaster recovery archive for essential Regulatory documents.
  • Perform other duties as required and assigned by supervisor .

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