Hong Kong FSP CRA
Core
Performs and coordinates all aspects of clinical monitoring and site management for clinical trials, ensuring protocol and regulatory compliance through remote or on-site visits.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data and compliance for life sciences therapies
Domain
Life Sciences / Clinical Research
Required skills
Clinical monitoring, ICH-GCP guidelines, Risk Based Monitoring, Root Cause Analysis, Data review (SDR/SDV/CRF), Investigational product inventory, Site initiation and close-out, Regulatory compliance
Preferred skills
Medical/therapeutic area knowledge, Microsoft Office proficiency, English language skills
Technologies
Clinical Trial Management System (CTMS)
Responsibilities
Monitor investigator sites using risk-based approach; Conduct on-site and remote monitoring visits; Ensure data accuracy through document review; Initiate and close out clinical trial sites; Participate in investigator meetings; Respond to audits and inspections; Maintain trial documentation and reports.
Seniority
Mid-level, hands-on IC