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THThermo Fisher Scientific

Clinical Trial Coordinator II(m/w/x)

Karlsruhe
Full-timeWith Home OfficeExperienced

Regulatory document review and issue resolution with monitors and sites for clinical research. GCP and clinical regulations adherence, with multi-project management experience required. Project tracking tools utilized for issue management.

Requirements

  • Degree in life sciences or equivalent
  • Adherence to GCP and clinical regulations
  • Ability to analyze project data accurately
  • Experience managing multiple simultaneous projects
  • Outstanding communication and teamwork skills
  • Excellent interpersonal and time management
  • Excellent English and German skills

Tasks

  • Review investigator files for clinical research services
  • Log outstanding issues in project tracking tools
  • Review regulatory documents for proper content
  • Liaise with monitors and sites to resolve regulatory issues
  • Disseminate study information and tracking updates to stakeholders
  • Identify potential investigators and distribute protocol packets
  • Prepare regulatory compliance review packages
  • Build meeting agendas and record minutes
  • Coordinate team conference calls and distribute minutes

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
  • GermanBusiness Fluent
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