Sr/CRA - FSP - Italy

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