FSP Sr CRA (Level I)
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and audit readiness for oncology clinical trials.
Role type
Senior IC clinical research associate (Level I)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/biotech sponsors
Domain
Life Sciences / Clinical Research / Oncology
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP guidelines, site initiation, data review (SDR/SDV/CRF), investigator management, audit preparation
Preferred skills
Oncology therapeutic area experience, rare diseases, neurology
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites for compliance and data accuracy; initiate and manage clinical trial sites; ensure audit readiness and document management; track trial status and progress; participate in investigator meetings; support project publications and process improvements.
Seniority
Senior, hands-on IC
