Fortrea seeks a Senior Clinical Research Associate II to oversee site monitoring and management for clinical studies in the Rome or Milan area. The role involves routine site visits, data integrity verification, regulatory compliance oversight, and project coordination, with travel required.
Responsibilities
Conduct routine and close-out monitoring visits, manage study files, and coordinate pre-study site initiations
Verify informed consent adherence and protocol compliance; ensure data integrity through source document review
Monitor for missing or implausible data; ensure audit readiness at site level
Track and follow-up on Serious Adverse Event reporting, including narratives and report production
Serve as lead monitor for assigned protocols; coordinate clinical projects as Local Project Coordinator when designated
Requirements




University degree in scientific or medical field plus 5 years experience, or 6+ years recent clinical monitoring experience
CRA certification per Italian Ministerial Decree November 15, ****
Minimum 5 years site monitoring and/or site management experience
Minimum 2 years experience in Oncology, Ophthalmology, Gene Therapy, or directly relevant therapeutic area
Fluent in local office language and English, written and verbal
Thorough knowledge of regulatory requirements and drug development process
Ability to work with minimal supervision and advanced site monitoring skills
Compensation:
€47,800–€63,000 gross per year

📌 Senior Clinical Research Associate Ii (Milano)
🏢 Fortrea
📍 Milano