Sr Clinical Research Associate - FSP
Thermo Fisher Scientific · Remote
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Role summary
Thermo Fisher Scientific seeks a Senior Clinical Research Associate to monitor investigational sites and manage clinical trial compliance across multiple sponsors. The role involves coordinating monitoring activities, ensuring protocol adherence, conducting site assessments, and maintaining collaborative relationships with research sites.
What they're looking for
- Bachelor's degree in life sciences or valid Registered Nursing certification
- Two or more years of clinical research monitoring experience
- Strong understanding of ICH-GCP guidelines and applicable regulations
- Critical thinking and root cause analysis skills for problem-solving
- Risk-based monitoring knowledge and proficiency
- Excellent written and oral communication abilities
- Valid driver's license where applicable
What you'll be doing
- Conduct remote and on-site monitoring visits to assess protocol compliance and regulatory adherence
- Perform source document review, verification, and CRF assessment for data accuracy
- Identify site process failures, document observations, and escalate deficiencies to management
- Maintain regular contact with investigational sites between visits to confirm protocol compliance
- Generate trial status reports, update clinical trial management systems, and conduct quality checks
Privacy & handoff
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