Start-up Associate
covance
Taipei City, Taiwan
3天前

Job Overview :

  • Collection, review, processing and tracking of regulatory and investigator documents to support Investigator Package submissions and revisions (e.
  • g. amendments), Ensure ongoing and timely updates of documents and systems

  • Site contract and budget negotiation
  • Prepare submissions to IRB / IEC
  • Collect and track regulatory and investigator documents required for effective and compliant site activation
  • Ensure Start-up and Maintenance activities are on track and support study deliverables to include providing accurate projections / timelines to study sites, proactive site management, and active participation in team meetings
  • Ensure high quality site documents are filed in TMF according to study plans
  • Education / Qualifications :

  • B.A. / B.S. (Life Science preferred) or equivalent healthcare experience
  • Minimum 1-2 years in Clinical Research or relevant healthcare experience
  • Experience :

  • Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
  • Good understanding of Global, Country / Regional Clinical Research Guidelines and ability to work within these guidelines.
  • Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications.
  • Strong MS Excel skills required.

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