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Clinical Trial Assistant (FSP) - Wuhan

1744 Parexel China Co., Ltd · Remote, China

Clinical TrialsRemoteExternal listingfull-timeabout 2 hours ago

About The Role

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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