Clinical Research Associate (CRA) - Vaccine/Infectious Disease (Remote)
Core
Ensures compliance of clinical study conduct with ICH/GCP and country regulations for assigned sites in the Vaccine/Infectious Disease domain.
Role type
Senior Clinical Research Associate (Site Management)
Builds
Clinical trial sites and data integrity for vaccine/infectious disease studies
Domain
Biotechnology / Clinical Research
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, Regulatory documentation management, Data accuracy verification, Site selection and validation, Remote and on-site monitoring, Root cause analysis, Multicultural communication
Preferred skills
None stated
Technologies
CTMS, eTMF, MS Office, Clinical IT applications
Responsibilities
Conduct site visits (initiation, monitoring, close-out) and manage site performance; Coordinate site readiness and recruitment; Ensure data completeness and subject safety; Resolve compliance issues and escalate per pathway; Maintain regulatory documentation; Act as SME for monitoring processes.
Seniority
Mid-to-Senior, hands-on IC