CRA I/II - FSP
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance for oncology and cell therapy trials.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical sponsors
Domain
Life Sciences / Oncology / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, data verification (SDV/SDR), regulatory compliance (ICH-GCP), site initiation, trial close-out, inventory management
Preferred skills
Medical/therapeutic area knowledge, Microsoft Office proficiency, presentation skills
Technologies
Clinical Trial Management Systems
Responsibilities
Monitor investigator sites using risk-based approaches; ensure data accuracy through document review; initiate and close out clinical trial sites; respond to audits and inspections; track trial status and provide progress reports; manage investigator payments and site relationships
Seniority
Mid-level, hands-on IC