Clinical Research Associate (CRA)
Core
Primary site contact and manager responsible for protocol compliance, data integrity, and subject safety across clinical trial phases.
Role type
Clinical Research Associate (Site Management & Monitoring)
Builds
Clinical research studies for bio/pharma sponsors and CROs
Domain
Healthcare / Clinical Trials / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Site management, Clinical trial monitoring, ICH-GCP compliance, Adverse event reporting, Protocol interpretation, Site selection and validation, Regulatory documentation management, Data integrity oversight, Root cause analysis, Site performance management
Preferred skills
Territory growth strategy, Audit and inspection leadership, Co-monitoring, Multicultural matrix environment navigation
Technologies
CTMS, eTMF, Microsoft Office, Clinical applications on mobile/tablet devices
Responsibilities
Conduct remote and on-site monitoring visits (initiation, monitoring, close-out), Manage site readiness and start-up activities, Identify and develop new clinical research sites, Prepare comprehensive visit and non-visit reports, Communicate with investigators regarding recruitment and protocol deviations, Resolve site performance and compliance issues, Maintain regulatory documentation and system records, Support audit and inspection activities
Seniority
Mid-level, hands-on IC
