Senior CRA
Core
Senior Clinical Research Associate monitoring investigator sites to ensure compliance with protocols and regulations, managing data accuracy, and overseeing investigational product inventory.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research / Pharma
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, ICH-GCP knowledge, EU/FDA regulatory knowledge, physical inventory management, data review (SDR/SDV/CRF), site initiation and close-out, investigator payment process management, clinical trial status tracking
Preferred skills
Medical/therapeutic area knowledge, Microsoft Office proficiency, process improvement initiatives
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches; ensure data accuracy through source data review; assess investigational product inventory; document observations and escalate deficiencies; initiate and close out clinical trial sites; track trial status and update study systems.
Seniority
Senior, independent monitoring
