Senior CRA level II
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for clinical trials.
Role type
Senior Clinical Research Associate (Level II)
Builds
Clinical trial data integrity and regulatory compliance
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based monitoring, Root cause analysis, Protocol compliance, ICH-GCP guidelines, Site initiation, Data review (SDR/SDV/CRF), Investigational product inventory, Audit readiness, Mentoring junior staff, Trial close-out
Preferred skills
Process improvement, Clinical trial management system (CTMS) proficiency, Medical terminology knowledge
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches, ensure data accuracy through document review, initiate clinical trial sites, conduct on-site file reviews, mentor new team members, provide trial status reports, respond to regulatory audits
Seniority
Senior, hands-on IC