Senior Clinical Research Associate I
Core
Performs and coordinates clinical monitoring and site management processes to ensure trial compliance with protocols, ICH-GCP guidelines, and regulations.
Role type
Senior Clinical Research Associate (Monitoring)
Builds
Clinical trial data integrity and regulatory compliance for life sciences therapies
Domain
Life Sciences / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based monitoring, root cause analysis, protocol compliance, ICH-GCP knowledge, site initiation, data review (SDR/SDV/CRF), investigator management, audit readiness
Preferred skills
Medical/therapeutic area knowledge, problem-solving, digital literacy
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; conduct on-site and remote monitoring visits; initiate clinical trial sites; perform trial close-out and material retrieval; respond to audits and inspections; provide trial status reports; manage investigator payments.
Seniority
Senior, hands-on IC