AbbVie seeks a Clinical Research Associate II to oversee oncology clinical trial sites across Italy, ensuring protocol compliance, data integrity, and effective sponsor-site partnerships. The role involves monitoring activities, training site staff, managing regulatory readiness, and proactively addressing study performance and safety issues.
Responsibilities
Conduct site evaluations, training, routine monitoring, and closure activities in accordance with GCP and protocol requirements
Serve as primary sponsor contact for investigative sites, providing contextual trial information and connecting stakeholders
Assess site risks proactively and implement preventative and corrective action plans with central monitoring team collaboration
Evaluate recruitment and retention strategies, ensure data quality submission, and verify audit and regulatory inspection readiness




Mentor less experienced CRAs and identify qualified investigators and potential study sites through networking
Requirements
Bachelor's degree in health-related field (medical, scientific, nursing, pharmacy preferred)
Minimum 1 year clinically related experience; 6 months in clinical research monitoring of investigational trials
Valid driver's license
Advanced knowledge of ICH/GCP Guidelines and local regulatory requirements
Strong cross-functional collaboration and stakeholder engagement skills
Proficiency with technology tools and risk-based monitoring approaches
Excellent written, verbal, and interpersonal communication abilities

📌 Clinical Research Associate Ii Oncology (Field Role, Nationwide Coverage) (Lazio)
🏢 Abbvie
📍 Lazio