CRA I/ II- FSP
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance for oncology studies, managing site processes and data reliability.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial data integrity and regulatory compliance for oncology studies
Domain
Life Sciences / Oncology
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, ICH-GCP knowledge, regulatory compliance, site initiation, trial close-out, data review (SDR/SDV/CRF), physical inventory management, investigator payment processing, travel management
Preferred skills
Oncology therapeutic area knowledge, medical terminology, Clinical Trial Management System (CTMS) proficiency, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; conduct on-site and remote monitoring activities including data and inventory reviews; initiate and close out clinical trial sites; ensure essential documents are complete and audit-ready; provide trial status tracking and progress reports; facilitate communication between sites, clients, and project teams; respond to regulatory audits and inspections.
Seniority
Mid-level, hands-on IC