Clinical Research Associate II (CRA II) – FSP Business Unit
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for pharmaceutical and biotech clients.
Role type
Clinical Research Associate II (IC)
Builds
Clinical trial data integrity and regulatory compliance for sponsors
Domain
Pharmaceutical/Biotech clinical trials
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, ICH-GCP knowledge, regulatory compliance, site management, data review (SDR/SDV/CRF), investigator site identification, trial close-out, travel management
Preferred skills
Life sciences background, nursing certification, therapeutic area knowledge, Microsoft Office proficiency
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; ensure data accuracy through document review; manage investigator payments and site initiation; conduct trial close-out and material retrieval; respond to audits and inspections; provide status reports to management; maintain essential study documents.
Seniority
Mid-level IC