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 monitoring and site management processes for pharmaceutical sponsors
Domain
Life Sciences / Oncology / Clinical Research
Deliverable
physical/clinical work
Required skills
Risk-based monitoring, Root cause analysis, Protocol adherence, ICH GCP knowledge, Investigational product inventory, Data review (SDR/SDV/CRF), Site initiation, Trial close-out
Preferred skills
Medical/therapeutic area knowledge, Advanced problem-solving
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites for compliance and data accuracy; Ensure audit readiness and document observations; Initiate and close out clinical trial sites; Track trial status and update study systems; Participate in investigator meetings; Facilitate communication between sites, clients, and project teams.
Seniority
Mid-level to Senior, hands-on IC
