Hong Kong FSP CRA
Core
Performs and coordinates clinical monitoring and site management for investigational sites to ensure protocol compliance, data accuracy, and subject safety.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/medical device sponsors
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, ICH-GCP guidelines, protocol adherence, site initiation, data review (SDR/SDV/CRF), investigator payment processing, audit readiness
Preferred skills
Medical/therapeutic area knowledge, clinical trial management systems (CTMS), process improvement
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; conduct on-site and remote monitoring visits; initiate clinical trial sites; ensure audit readiness and document completeness; track trial status and progress; participate in investigator meetings; manage investigator payments; support study close-out and material retrieval
Seniority
Mid-level, hands-on IC