My name is Maggie, and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Clinical Trial Document Clerk for a prominent client of ours. This position is located in Wilmington, DE. Details for the position are as follows:
- 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 Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements.
- Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the Authoring Guide for Regulatory Documents to support publishing in GEL
- 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).
- Set-up, populate and accurately maintain information in tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems
- Clinical Trial DOCUMENT MANAGEMENT and regulatory documents
- Veeva experience a plus (NOT required)
- Must be methodical, compliant to processes yet flexible when needed
If you are interested in hearing more about the position please respond to this posting with your resume attached.
Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate hired
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 GroupLooking 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