Senior CRA - FSP - Medical Device - US Central/West Coast
Thermo Fisher Scientific · Remote
Clinical OperationsRemoteFull timeCompany career page
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Role summary
Senior Clinical Research Associate (Level I) for remote medical device trials across US Central/West Coast. Conduct on-site and remote monitoring of investigator sites, ensure protocol compliance and data integrity, and manage documentation across multiple sponsor environments.
What they're looking for
- Bachelor's degree in life sciences or RN certification with relevant academic qualification
- 2+ years clinical research monitoring experience or equivalent combination of education and experience
- Valid driver's license where applicable
- Strong understanding of ICH-GCP guidelines and applicable regulations
- Demonstrated critical thinking and root cause analysis skills
- Proficiency with clinical trial management systems (CTMS)
- Excellent written and oral communication abilities
What you'll be doing
- Conduct risk-based monitoring visits to assess protocol compliance and regulatory adherence at investigational sites
- Perform source data review and CRF verification through on-site and remote activities to ensure data accuracy
- Document findings and escalate deficiencies to clinical management with timely follow-up to resolution
- Provide trial status reports and updates to Clinical Team Manager; maintain CTMS system accuracy
- Facilitate communication between investigative sites, sponsors, and project teams; support investigator meetings and site initiation
Privacy & handoff
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