FSP Sr. CRA (Oncology & Cell Therapy)
Core
Senior Clinical Research Associate managing complex oncology and cell therapy clinical trials, ensuring protocol compliance, subject safety, and data integrity through risk-based monitoring.
Role type
Senior Clinical Research Associate (Oncology & Cell Therapy)
Builds
Clinical trials for pharmaceutical and biotech sponsors
Domain
Life Sciences / Oncology / Cell Therapy
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, corrective and preventive actions (CAPA), protocol compliance, ICH-GCP guidelines, site management, investigational product accountability, clinical trial initiation and close-out, data integrity, regulatory compliance
Preferred skills
Medical/therapeutic area knowledge, mentorship of junior CRAs, process improvement initiatives
Technologies
Clinical Trial Management Systems (CTMS), Microsoft Office
Responsibilities
Conduct on-site and remote monitoring visits to assess protocol and regulatory compliance; manage site processes and guidelines from various sponsors; identify site process gaps and implement CAPA; prepare monitoring reports and follow-up letters; maintain communication with investigative sites; support investigator payment activities; participate in investigator meetings and site identification/qualification; ensure essential documents are complete and accurate; track trial status and update study systems; facilitate communication between sites, clients, and project teams; respond to audits and inspections.
Seniority
Senior, hands-on IC with mentorship responsibilities
