CRA (Level II)
Thermo Fisher Scientific · Remote
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Role summary
Thermo Fisher Scientific seeks a Level II Clinical Research Associate to monitor investigational sites and manage clinical trial operations remotely from Austria. The role involves conducting risk-based site visits, ensuring protocol compliance, managing documentation, and coordinating between sponsors and trial sites across multiple therapeutic areas.
What they're looking for
- Bachelor's degree in life sciences or registered nursing certification
- Approximately 1 year clinical research monitoring experience or fellowship completion
- Strong knowledge of ICH-GCP guidelines and applicable regulations
- Demonstrated critical thinking, root cause analysis, and problem-solving abilities
- Proficient oral and written communication skills with medical personnel
- Experience with risk-based monitoring concepts and processes
- Valid driver's license where applicable
What you'll be doing
- Conduct remote and on-site monitoring visits using risk-based approach; perform SDR, SDV, and CRF reviews
- Assess investigational product inventory and records; document observations in compliance reports
- Initiate clinical trial sites, conduct investigator meetings, and perform trial close-out and material retrieval
- Maintain essential documents, conduct file reviews, and provide study status updates to clinical management
- Facilitate communication between investigative sites, sponsor companies, and project teams; respond to audits and inspections
Privacy & handoff
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