FSP Clinical Research Associate II
Core
Performs and coordinates clinical monitoring and site management, conducting remote or on-site visits to assess protocol and regulatory compliance.
Role type
Clinical Research Associate II
Builds
Clinical trials for sponsors (FSO, FSP, Government)
Domain
Clinical Research / Life Sciences
Required skills
Clinical monitoring, Risk Based Monitoring, Root Cause Analysis, ICH-GCP guidelines, Protocol adherence, Data accuracy (SDR/SDV/CRF), Investigational product inventory, Site initiation, Trial close out, Regulatory compliance
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Microsoft Office
Technologies
Clinical Trial Management System (CTMS)
Responsibilities
Monitor investigator sites with a risk-based approach, Ensure data accuracy through document review, Conduct on-site file reviews, Initiate clinical trial sites, Perform trial close out, Provide trial status tracking reports, Respond to audits/inspections, Manage investigator payments
Seniority
Mid-level, hands-on IC