CRA/ Sr. CRA
Core
Conducts remote or on-site clinical monitoring and site management to ensure protocol and regulatory compliance, guaranteeing subject rights and data reliability.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial sites and data integrity
Domain
Life sciences / Clinical research
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, ICH-GCP compliance, regulatory compliance, data accuracy review (SDR/SDV/CRF), physical inventory management, site initiation, trial close out, audit response, international travel
Preferred skills
International monitoring experience
Technologies
Clinical Trial Management System
Responsibilities
Monitor investigator sites using a risk-based approach; ensure data accuracy through document review; initiate and close out clinical trial sites; respond to audits and inspections; provide trial status reports; facilitate communication between sites, clients, and project teams.
Seniority
Senior, hands-on IC