Senior Clinical Research Associate II - FSP Model - Rome Area
Core
Senior Clinical Research Associate responsible for site monitoring, site management, and local project coordination for clinical studies.
Role type
Senior Clinical Research Associate (Site Monitoring & Project Coordination)
Builds
Clinical studies for pharmaceutical and medical device sponsors
Domain
Clinical Research / Life Sciences
Deliverable
physical/clinical work
Required skills
Site monitoring, Source document review, SAE reporting, Regulatory compliance, Data integrity verification, Budget negotiation, Team mentoring, Project coordination
Preferred skills
Clinical trial management system (CTMS) experience, Local project management experience, Medical device customer service experience
Technologies
Clinical trial management systems (CTMS), Microsoft Office
Responsibilities
Conduct routine and close-out site monitoring visits; Verify informed consent and protocol adherence; Review source documents for data integrity; Monitor data for missing or implausible entries; Ensure audit readiness; Negotiate study budgets with investigators; Track and report Serious Adverse Events (SAEs); Assist in training and mentoring junior staff; Coordinate clinical projects as a Local Project Coordinator.
