Senior Clinical Research Associate

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

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 fondamental

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