CRA I/ II- FSP - Spain
Core
Clinical Research Associate performing risk-based monitoring, site management, and audit readiness for oncology clinical trials.
Role type
Junior to mid-level Clinical Research Associate (CRA)
Builds
Clinical trial data reliability and regulatory compliance for pharmaceutical sponsors
Domain
Life Sciences / Oncology / 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, trial close-out, data review (SDR/SDV/CRF), investigator payment processing
Preferred skills
Oncology therapeutic area knowledge, Registered Nursing certification, experience with FSO/FSP/Government monitoring environments
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to ensure protocol and regulatory compliance; Conduct on-site and remote monitoring activities including data review and inventory checks; Initiate and close out clinical trial sites; Prepare and maintain essential study documents; Track trial status and provide progress reports to management; Respond to regulatory audits and inspections.
Seniority
Junior to Mid-level, hands-on IC