Senior Clinical Research Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8hqacd

OverviewAs 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.
ResponsabilitàProvide 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 fondamentaliEU: ?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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8hqacd