FSP Experienced Clinical Research Associate (CRA II/Sr. CRA I) - Oncology
Core
Conduct remote or onsite monitoring visits to assess regulatory compliance, manage documentation, and ensure trial conduct per protocol and ICH GCP guidelines for oncology clinical trials.
Role type
Senior Clinical Research Associate (Oncology)
Builds
Clinical trial data reliability and regulatory compliance for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research / Oncology
Deliverable
client delivery
Required skills
Risk-based monitoring, Root cause analysis, Protocol adherence, ICH GCP knowledge, Site management, Data review (SDR/SDV/CRF), Investigational product inventory, Audit readiness
Preferred skills
Medical/therapeutic area knowledge, Clinical trial management system proficiency, Process improvement
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; Ensure data accuracy through document and source data verification; Manage investigator site initiation and close-out; Respond to regulatory audits and inspections; Track trial status and update study systems
Seniority
Senior, hands-on IC