(Sr) Clinical Research Associate - Belgium
Core
Senior Clinical Research Associate conducting remote and on-site monitoring of investigator sites to ensure protocol and regulatory compliance in clinical trials.
Role type
Senior Clinical Research Associate (Level I)
Builds
Clinical trial data reliability and subject safety
Domain
Pharmaceutical/Biotech clinical research
Deliverable
physical/clinical work
Required skills
Risk-based monitoring, Root cause analysis, ICH-GCP guidelines, Protocol adherence, Site management, Data review (SDR/SDV/CRF), Investigational product inventory, Regulatory compliance
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management Systems (CTMS), Travel management
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approach; Conduct on-site and remote monitoring visits; Ensure audit readiness and document observations; Manage investigator payments and site initiation; Track trial status and update study systems; Respond to regulatory audits and inspections.
Seniority
Senior, hands-on IC