Senior Clinical Research Associate (Level I) at Thermo Fisher Scientific to conduct remote and on-site monitoring of investigational sites across clinical trials. Responsibilities include protocol compliance assessment, data accuracy verification, site management, and regulatory documentation coordination across multiple sponsor environments.
Responsibilities
Conduct remote and on-site monitoring visits using risk-based approach to assess protocol and regulatory compliance
Review source data records, case report forms, and investigational product inventory to ensure data accuracy and integrity
Document monitoring observations in reports and escalate deficiencies to clinical management for timely resolution
Prepare trial status updates and ensure clinical trial management systems are maintained per study conventions
Coordinate investigator meetings, site initiation,
trial closeout, and retrieval of essential trial materials
Requirements
- Bachelor's degree in life sciences or RN certification with equivalent qualification
- 2+ years clinical research monitoring or equivalent combined education and experience
- Proficiency with ICH-GCP guidelines, applicable regulations, and procedural documentation
- Strong critical thinking, root cause analysis, and risk-based monitoring skills
- Excellent written and oral communication with medical and clinical personnel
- Proficient in Microsoft Office and ability to learn clinical trial management software
- Valid driver's license where applicable
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