in-house CRA, Czech Rep - FSP
Covance Inc
Prague, Czech Republic
před 3 dny

Job Overview :

Covance is looking to recruit in-house CRA (Clinical Trial Coordinator)to join our sponsor in Czech Rep

Responsibilities :

  • Trial and site administration :
  • Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
  • Ensure collation and distribution of study tools and documents o Update clinical trial databases (CTMS) and trackers
  • Clinical supply & non-clinical supply management, in collaboration with other country roles
  • Manage Labeling requirements and coordinate / sign translation change request
  • Document management :
  • Prepare documents and correspondence
  • Collate, distribute / ship, and archive clinical documents o Assist with eTMF reconciliation
  • Updating manuals / documents (e.g., patient diaries, instructions) o Document proper destruction of clinical supplies.
  • Prepare Investigator trial file binders o Execute eTMF Quality Control Plan o Obtain translations of documents
  • Regulatory & Site Start-Up responsibilities :
  • Provide to and collect from investigators forms / lists for site evaluation / validation, site start-up and submissions
  • Obtain, track and update study insurance certificates
  • Support preparation of submission package for IRB / ERC and support regulatory agencies submissions.
  • Publish study results for GCTO and RA where required per local legislation
  • Budgeting, Agreement and Payments :
  • Collaborate with finance / budgeting representatives for :
  • Develop country and site budgets (including Split site budget) Tracking, and reporting of negotiations
  • Maintenance of tracking tools
  • Contract development, negotiation, approval and maintenance (e.g. CTRAs)
  • Update and maintain contract templates (in cooperation with Legal Department)
  • Payment calculation and execution (investigators, vendors, grants)
  • Ensure compliance with financial procedures
  • Monitor and track adherence and disclosures,
  • Budget closeout.
  • Education / Qualifications :

  • University Degree
  • Experience :

  • Proven experience in Clinical Research or relevant healthcare experience
  • Fluent English and local language
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