FSP Sr. CRA (Oncology & Cell Therapy)
Core
Senior Clinical Research Associate managing clinical monitoring and site management for oncology and cell therapy trials.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and biotech sponsors
Domain
Life Sciences / Oncology & Cell Therapy
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP guidelines, site initiation and close-out, investigational product accountability, CAPA implementation
Preferred skills
Medical/therapeutic area knowledge, mentorship of junior CRAs, complex study management
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based monitoring approach; perform on-site and remote monitoring activities including SDV and CRF review; prepare monitoring reports and follow-up letters; manage site processes and ensure audit readiness; support site identification, qualification, initiation, and close-out activities; track trial status and update study systems; facilitate communication between sites, client, and project team.
Seniority
Senior, hands-on IC with mentorship responsibilities
