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Clinical Documentation Studies Associate

The Fountain Group Wilmington, DE

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Hello,

My name is Keti, and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Clinical Documentation Studies Associate for a prominent client of ours. This position is located in Wilmington, DE. Details for the position are as follows:

Job Description:

  • Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements. Support the CRA in the maintenance and close out activities for the ISF.
  • Contribute to the production and maintenance of study documents, ensuring template and version compliance.
  • Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance.
  • Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).

Qualifications:

  • Clinical Trial regulatory document management experience.
  • TMF experience.
  • Veeva experience is a plus.

If you are interested in hearing more about the position, please respond to this posting with your resume attached 

Company Description
Looking for a new career, or a change from your current work environment?

The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field

The Fountain Group

Looking for a new career, or a change from your current work environment? The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field

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Address

Wilmington, DE
19850 USA

Industry

Healthcare

Website

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