CRA - Remote

25 ott - Milano
Thermo Fisher Scientific

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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