Experteer Overview
As a Senior Clinical Research Associate, you will independently conduct site monitoring for clinical trials and provide leadership to the CRA team to ensure protocol compliance and data quality. You will collaborate with cross-functional groups across the US and EU to resolve site issues, train sites, and support study recruitment and budgeting. This role offers opportunity to influence monitoring strategy, improve study execution, and work within a values-driven, global team. Your work will directly support high-quality trials in a fast-paced, international setting.

Compensaciones / Incentivos
• Provide guidance and oversight to the CRA team to meet scope, SOPs, timelines, and budgets
• Review monitoring visit reports and conduct co-monitoring and evaluation visits
• Coordinate site visits and ensure timely investigator site engagement
• Collaborate with cross-functional departments to resolve monitoring-related issues
• Assist in development of study-specific Monitoring Plans and training materials
• Support site ethics documents setup and site contract negotiation
• Provide monthly billing information to finance
• Manage study budget for monitoring stand-alone projects and act as sponsor referent
• Perform qualification, initiation, interim,



and close-out visits (remote and onsite) with proper documentation
• Prepare monitoring visit reports detailing problems, resolutions, and enrollment status
• Ensure CRF data integrity through source data verification and eTMF/TMF QA
• Conduct investigational product accountability and site regulatory binder reviews
• Maintain site relationships to ensure protocol/GCP compliance and address sponsor requests
• Ensure adherence to ICH GCP, FDA regulations, and SOPs
• Participate in meetings and support CRA onboarding and mentoring
• Collaborate on CTMS development/maintenance and manage prioritization of tasks
• Handle additional duties as assigned

Responsabilidades
• EU: minimum 3 years of clinical monitoring experience
• Oncology experience
• Availability to travel
• Strong command of English (US) and local language (EU)
• Permanent work authorization in the US or appropriate EU status
• Bachelor in a scientific health field (per regional requirements)
• Knowledge of ICH GCP and local regulatory requirements
• Experience with clinical trial management systems and eTMF processes

Requisitos principales
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📌 Senior Clinical Research Associate (Barcelona)
🏢 Alira Health
📍 Barcelona