Cra (level Ii) - Fsp Vaccines - Southeast

Thermo Fisher Scientific UK

Remote, United Kingdom
Remote
Risk-based monitoring approach
Ich-gcp guidelines
Site processes specialist
Thermo Fisher Scientific UK is seeking a Clinical Research Associate (Level II) to join their remote team, focusing on the management and monitoring of clinical trials, specifically in the vaccine sector. The role requires ensuring compliance with protocols and regulations while fostering relationships with investigative sites

Job Summary

  • Perform and coordinate all aspects of the clinical monitoring and site management process, conducting remote or on-site visits to assess protocol and regulatory compliance.
  • Ensure trial conduct aligns with approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subject rights, well-being, and data reliability.
  • Develop collaborative relationships with investigational sites, ensuring audit readiness and facilitating effective communication between sites, clients, and project teams.

Matching Summary

Match Score: 85

Thermo Fisher Scientific UK is seeking a Clinical Research Associate (Level II) to join their remote team, focusing on the management and monitoring of clinical trials, specifically in the vaccine sector. The role requires ensuring compliance with protocols and regulations while fostering relationships with investigative sites.

Skills & Requirements

Must-have

  • Risk-based monitoring approach
  • ICH-GCP guidelines
  • Site processes specialist
  • Data accuracy through SDR/SDV/CRF review
  • Investigational product assessment
  • Timely report documentation
  • Issue escalation and resolution
  • Essential document completeness

Nice-to-have

  • Root cause analysis skills
  • Critical thinking and problem-solving
  • Collaborative relationships with sites
  • Project publications/tools contribution
  • Process improvement initiatives

Key Requirements

  • Bachelor's degree in life sciences or equivalent
  • 1 year clinical research monitor experience
  • Valid driver's license where applicable

Work Rights

Not specified

Tailored Resume

Cover Letter