FSP Sr. CRA (Oncology & Cell Therapy)
Core
Senior Clinical Research Associate managing clinical monitoring and site management for oncology and cell therapy trials, ensuring protocol compliance and data integrity.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data 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, Investigational product accountability, Site initiation and close-out, CAPA implementation
Preferred skills
Medical/therapeutic area knowledge, Mentorship of junior CRAs, Process improvement initiatives
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 SDR, SDV, and CRF review; Manage site processes and ensure audit readiness; Support investigator payment activities and site identification/qualification; Conduct on-site file reviews and ensure essential documents are complete; Provide trial status tracking and progress update reports.
Seniority
Senior, hands-on IC with mentorship responsibilities