Senior Cra (level I)

Thermo Fisher Scientific UK

Austria, Austria
Fully remote
Clinical monitoring and site management
Ich-gcp guidelines compliance
Risk-based monitoring approach
Perform and coordinate all aspects of the clinical monitoring and site management process, ensuring protocol and regulatory compliance

Job Summary

  • Perform and coordinate all aspects of the clinical monitoring and site management process, ensuring protocol and regulatory compliance.
  • Monitor investigator sites using a risk-based approach, applying root cause analysis and critical thinking to identify and resolve process failures.
  • Facilitate effective communication between investigative sites, clients, and project teams, responding to company, client, and regulatory requirements.

Matching Summary

Perform and coordinate all aspects of the clinical monitoring and site management process, ensuring protocol and regulatory compliance.

Skills & Requirements

Must-have

  • Clinical monitoring and site management
  • ICH-GCP guidelines compliance
  • Risk-based monitoring approach
  • Data accuracy through SDR, SDV, CRF review
  • Investigational product assessment
  • Site process failure analysis
  • Effective communication with medical personnel

Nice-to-have

  • Collaborative relationships with sites
  • Critical thinking and problem-solving
  • Adaptable in various scenarios
  • Team player and independent worker
  • Process improvement contributions

Key Requirements

  • 2+ years as a clinical research monitor
  • Bachelor's degree in life sciences or equivalent
  • Valid driver's license where applicable
  • Proficient German and English language skills

Work Rights

Not specified

Tailored Resume

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