16 ott - Verona
Alira Health
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
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