Experienced Clinical Research Associate (Level I/II) - FSP - Multi Therapeutics - Central US
Thermo Fisher Scientific · Remote
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Role summary
Thermo Fisher Scientific seeks an experienced Clinical Research Associate (Level I/II) to monitor investigational sites, ensure protocol compliance, and manage clinical trial documentation. This remote position involves coordinating site visits, conducting data reviews, and maintaining regulatory compliance across multiple therapeutic programs in a fast-paced clinical research environment.
What they're looking for
- Bachelor's degree in life sciences or registered nursing certification
- Approximately one year of clinical research monitoring experience or PPD Drug Development Fellowship completion
- Proficient knowledge of ICH-GCP guidelines and applicable regulations
- Strong critical thinking and root cause analysis capabilities
- Demonstrated medical terminology knowledge and therapeutic area understanding
- Excellent written and oral communication skills
- Valid driver's license where applicable
What you'll be doing
- Conduct risk-based monitoring visits to assess protocol compliance and regulatory adherence at investigational sites
- Perform source document review, verification, and case report form audits through on-site and remote activities
- Document monitoring observations in formal reports and escalate deficiencies to clinical management
- Coordinate investigator meetings, site initiation, trial closeout, and retrieval of trial materials
- Maintain essential documentation completeness and provide trial status tracking to clinical team leadership
Privacy & handoff
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