FSP Clinical Research Associate (Level I or II)
Core
Coordinate clinical monitoring and site management to ensure trials comply with protocols, ICH-GCP guidelines, and regulations, guaranteeing subject rights and data reliability.
Role type
Clinical Research Associate (Level I or II)
Builds
Clinical trials for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research
Required skills
Clinical monitoring, Risk Based Monitoring, Root Cause Analysis, Protocol compliance, ICH-GCP knowledge, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Microsoft Office
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Conduct on-site and remote monitoring visits to assess compliance; Initiate and close out clinical trial sites; Review essential documents and conduct file reviews; Track trial status and provide progress reports; Facilitate communication between sites, clients, and project teams; Respond to audits and inspections.
Seniority
Entry to Mid-level, hands-on IC