Senior Clinical Research Associate
Core
Ensure successful protocol-level execution of Site Management and Monitoring (SMM) deliverables including start-up, execution, and close-out for assigned clinical studies.
Role type
Senior Clinical Research Associate (SMM Lead)
Builds
Clinical trial execution and site management for immunology, oncology, and neuroscience studies
Domain
Clinical Research / Pharmaceutical
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Site monitoring, protocol execution, regulatory compliance (GCP/ICH), audit/inspection readiness, CRA mentoring, training facilitation, data review
Preferred skills
Health-related degree, country point of contact experience, global task force participation
Technologies
Clinical trial management systems, Integrated Data Review Plan (IDRP)
Responsibilities
Conduct monitoring visits and site evaluations; ensure audit and inspection readiness; coach and mentor CRAs; facilitate global training solutions; perform remote data review; serve as country point of contact for CROs
Seniority
Senior, hands-on IC with mentoring responsibilities