Clinical Research Associate
Core
Manage assigned clinical study protocols and investigational sites to ensure compliance with ICH-GCP guidelines, local regulations, and sponsor policies.
Role type
Senior Clinical Research Associate (Site Management & Monitoring)
Builds
Clinical trials for pharmaceutical/biotechnology sponsors
Domain
Healthcare / Clinical Research
Deliverable
physical/clinical work
Required skills
ICH-GCP guidelines, site qualification/validation, remote and on-site monitoring, regulatory documentation management, root cause analysis, CAPA implementation, patient recruitment strategies, clinical systems proficiency (CTMS, eTMF), data accuracy verification
Preferred skills
Subject matter expert (SME) in monitoring processes, new investigator site development, cross-functional stakeholder coordination
Technologies
CTMS, eTMF, mobile monitoring tools, Microsoft Office
Responsibilities
Conduct site qualification, initiation, interim, and close-out visits; ensure data completeness and participant safety; manage regulatory documentation and audit readiness; resolve site performance and compliance issues; support study delivery through stakeholder coordination
Seniority
Mid-level, hands-on IC