Sr CRA (Level I) - FSP
Core
Senior Clinical Research Associate conducting risk-based monitoring, site management, and compliance assurance for oncology/hematology clinical trials.
Role type
Senior IC Clinical Research Associate (Oncology/Hematology)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical/biotech sponsors
Domain
Life Sciences / Clinical Research / Oncology & Hematology
Deliverable
physical/clinical work
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP knowledge, site initiation, data review (SDR/SDV/CRF), investigator management
Preferred skills
None stated
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
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 site selection; Manage investigator payments and trial close-out.
Seniority
Senior, hands-on IC