FSP Clinical Research Associate II
Core
Coordinate clinical monitoring and site management to ensure trials comply with protocols, ICH-GCP guidelines, and regulations while guaranteeing subject rights and data reliability.
Role type
Senior IC clinical research associate (monitoring)
Builds
Clinical trials for pharmaceutical and biotech sponsors
Domain
Life sciences / Clinical research
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP knowledge, site initiation, trial close-out, data review (SDR/SDV/CRF), investigator payment processing, regulatory audit response
Preferred skills
Medical/therapeutic area knowledge, problem-solving, critical thinking, Microsoft Office proficiency
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; initiate and close out clinical trial sites; conduct on-site file reviews and physical inventory checks; track trial status and update study systems; respond to regulatory audits and inspections; facilitate communication between sites, clients, and project teams.
Seniority
Mid-level, hands-on IC