Senior Clinical Research Associate
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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
- 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
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