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 quality and compliance. You’ll collaborate with cross-functional groups across the US and EU to address site questions, support recruitment, and train sites. The role blends hands-on monitoring with guidance on budgets, visits, and regulatory documentation, contributing to trial success in a fast-paced environment. This position offers impact in a global, collaborative culture that values courage, accountability, honesty, inclusivity, and elevating others. Responsabilità
* Provide guidance and oversight to the CRA team to ensure adherence to scope, SOPs, timelines, and budgets
* Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed
* Coordinate with cross-functional departments for issue resolution in monitoring activities
* Assist in development of study-specific Monitoring Plans and training materials
* Support site ethics documents setup and site contract negotiations
* 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 accurate monitoring visit reports detailing site issues, resolutions, and progress
* Ensure data integrity through source document verification and eTMF/TMF quality checks
* Conduct investigational product accountability and review regulatory binders
* Maintain site contact to ensure protocol/GCP compliance and patient accrual monitoring
* Ensure compliance with ICH GCP, FDA regulations, and SOPs
* Participate in meetings and training activities; mentor new CRAs and support onboarding
* Collaborate on CTMS development and maintenance
* Prioritize conflicting demands to meet commitments
* Perform additional duties as assigned Requisiti fondamentali
* EU: ≥4 years of clinical monitoring experience in pharma/biotech/CRO
* Ability to travel in Italy
* Oncology experience
* Strong command of English (written and verbal) and local language proficiency in country of monitoring
* Permanent work authorization in the US; valid in EU Italy
* Graduation in a scientific health field
* Experience with regulatory/ethical requirements and ICH GCP
* Quality-focused and detail-oriented
* Strong organizational and multitasking abilities
* Problem-solving under pressure
* Clinical trial management systems (CTMS)
* Electronic data capture (EDC)
* eTMF/TMF document handling

📌 Senior Clinical Research Associate (Verona)
🏢 Alira Health
📍 Verona