FSP CRA (Level II)
Core
Conducts remote and on-site clinical monitoring and site management to ensure protocol and regulatory compliance, manage documentation, and guarantee subject rights and data reliability.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial services for pharmaceutical and biotech clients
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, critical thinking, problem-solving, ICH-GCP knowledge, regulatory compliance, site initiation, trial close-out, data review (SDR/SDV/CRF), investigator payment processing, document management
Preferred skills
Medical/therapeutic area knowledge, Microsoft Office proficiency, digital literacy
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches; initiate and close out clinical trial sites; conduct on-site file reviews; track trial status and update study systems; facilitate communication between sites, clients, and project teams; respond to audits and inspections.
Seniority
Mid-level, hands-on IC