Clinical Research Associate (CRA) - Cardiovascular (Remote)
Core
Ensures compliance of clinical study conduct with ICH/GCP and regulations, manages assigned sites, and develops new clinical research sites for cardiovascular trials.
Role type
Senior Clinical Research Associate (Site Management)
Builds
Clinical trial sites and data integrity for cardiovascular studies
Domain
Healthcare / Clinical Research / Cardiovascular
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Site management, ICH-GCP compliance, Adverse event reporting, Protocol adherence, Site selection and validation, Regulatory documentation management, Data accuracy verification, Remote and on-site monitoring, Root cause analysis, Site performance improvement
Preferred skills
Territory development, Audit/inspection support, Co-monitoring, Process SME, Mentorship
Technologies
CTMS, eTMF, Clinical IT applications
Responsibilities
Perform remote and on-site monitoring visits (initiation, monitoring, close-out) to ensure data completeness and subject safety; Manage site relationships and resolve performance/compliance issues; Coordinate site readiness and participate in site selection; Collect and review regulatory documentation; Conduct root cause analysis and implement corrective actions; Contribute to team knowledge as a process SME.
Seniority
Mid-Senior, hands-on IC
