CRA / Sr. CRA
Core
Conducts remote and on-site clinical monitoring and site management to ensure protocol compliance, data accuracy, and subject safety across international trials.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical trial operations and data integrity for pharmaceutical/biotech sponsors
Domain
Life Sciences / Clinical Research
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP knowledge, site initiation, audit readiness, data review (SDR/SDV/CRF), investigator management, travel management
Preferred skills
International monitoring experience, process improvement, stakeholder collaboration
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches; initiate and close out clinical trial sites; conduct on-site file reviews; track trial status and progress; respond to regulatory audits and inspections; manage investigator payments and inventory.
Seniority
Senior, hands-on IC