Sr CRA (Level I) - FSP
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and regulatory compliance for oncology clinical trials.
Role type
Senior IC Clinical Research Associate (Oncology)
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), Investigational product inventory, Audit readiness
Preferred skills
Oncology therapeutic area knowledge, Clinical Trial Management Systems (CTMS), Project publications preparation
Technologies
Microsoft Office, Clinical Trial Management Systems (CTMS)
Responsibilities
Conduct on-site and remote monitoring visits to assess protocol and regulatory compliance; Initiate and manage clinical trial sites; Ensure audit readiness and document observations; Track trial status and update study systems; Participate in investigator meetings and ensure trial close-out.
Seniority
Senior, hands-on IC
