Clinical Research Associate - SOAR
Core
Clinical Research Associate supporting the start-up phase of oncology clinical trials, focusing on site selection, qualification, and activation.
Role type
Clinical Research Associate (Study Start-up)
Builds
Clinical trial sites ready for patient enrollment
Domain
Pharmaceutical / Oncology
Deliverable
physical/clinical work
Required skills
Site qualification, regulatory document management, contract management, KPI analysis, risk-based monitoring, patient recruitment support, ICH-GCP compliance
Preferred skills
Analytical/risk-based monitoring, oncology trial experience, system proficiency (CTMS, EDC, eTMF, IWRS)
Responsibilities
Identify and select clinical trial sites, perform Site Qualification Visits (SQVs), coordinate regulatory approvals and contracts, monitor site activation progress, manage investigator contracts, report on start-up KPIs, prepare for audits and inspections
Seniority
Mid-level, hands-on IC
