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Parexel

Clinical Trial Assistant (FSP) - Wuhan

Posted 4 days ago
0-2 years experience
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AI Summary

The Clinical Trial Assistant is responsible for maintaining the Trial Master File (TMF), coordinating EC submissions, and managing site-level documentation. They also provide administrative support for site contracts, payments, and the distribution of study materials.

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Role and Responsibilities Summary:  

  • TMF: Set up and maintain the site level TMF/cTMF, coordinate on document collection, uploading into SharePoint (SP)eTMF, check the document completeness, and provide TMF/eTMF quality control (QC) if required. 
  • EC Submission: Coordinate on EC submission dossier, site start-up preparation, and EC fee application and tracking.  
  • Process protocol amendments may include ICF updates. 
  • Tracker/Metrics Report: Collect and update study trackers/metrics report for site level if needed. 
  • Site Contract and Payment: Assist in contract signature process; assist in site level payment initiative and payment and invoice tracking. 
  • Site Materials and Equipment: Distribute site materials and equipment, document printing, shipment, and other administrative work. 
  • Administrative: Business and department office administration support if required. 
  • To undertake other reasonably related duties as may be assigned from time to time, as appropriate for level of experience 

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