Clinical Research Associate II (CRA II) - Late Phase

• Site Monitoring & Oversight: Conduct on-site and remote monitoring visits across late phase studies, ensuring compliance with protocols, ICH-GCP, regulatory requirements, and applicable device regulations
• Late Phase Study Delivery: Support execution of post-authorisation, observational, and interventional studies, ensuring high-quality data collection and real-world evidence generation
• Site Performance & Issue Resolution: Evaluate site performance, identify risks, and implement solutions to ensure studies are delivered on time and to quality standards
• Cross-Functional Collaboration: Partner with project teams, medical, data management, and commercial stakeholders to ensure efficient study delivery and reporting
• Training & Mentorship: Provide guidance and support to site personnel and junior CRAs, maintaining consistency and best practice, where applicable
• Stakeholder Engagement: Build strong relationships with investigators and site staff to drive engagement and successful study execution

• Advanced degree in Life Sciences, Nursing, Pharmacy, or Medicine and Certification for monitoring trials
• Experience as a Clinical Research Associate, ideally within late phase / Phase IV / real-world studies (1-2 years min)
• Experience across both investigational product (IP) and medical device trials is highly desirable
• Strong understanding of ICH-GCP, regulatory requirements, and post-marketing study environments
• Proven ability to manage multiple sites and competing priorities
• Expertise in site monitoring, data integrity, and risk-based monitoring approaches
• Proficiency in clinical systems (e.g., CTMS, EDC)
• Willingness to travel across Italy (~6–8 days per month)
• Excellent communication, stakeholder management, and influencing skills

Experience across both investigational product (IP) and medical device trials

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others