Clinical Research Associate, Site Management - Italy

Experteer Overview

As a Clinical Research Associate, you monitor and manage study sites to ensure protocol adherence, regulatory compliance, and timely data reporting. You will work with sites to optimize recruitment, train investigators, and maintain essential study documentation. You ensure data quality, handle regulatory submissions, and support start-up activities as needed. This role sits within a broader team focused on delivering high-quality clinical research outcomes and patient-focused results.

Retribuzione / Benefits

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP/ICH guidelines
• Collaborate with sites to plan, drive, and track subject recruitment to meet project needs
• Administer protocol training and establish ongoing communication to manage expectations and issues
• Assess site practices for protocol compliance and regulatory adherence; elevate quality issues
• Track regulatory submissions, approvals, recruitment/enrollment, CRF completion/submission, and data queries; may support start-up
• Ensure site documents are filed in the Trial Master File (TMF) and ISF maintained per regulatory requirements
• Document site management activities, visit findings, and action plans; issue follow-up letters
• Collaborate with study team for project execution support; may contribute to recruitment plans and site-level financials when applicable

Responsabilità

• Master's Degree in Life Sciences
• CRA certification according to ministerial requirements
• Completion of CRA training program or prior monitoring experience
• Knowledge of GCP/ICH guidelines
• Good therapeutic and protocol knowledge as provided in company training
• Proficiency in Microsoft Word, Excel and PowerPoint; basic computer proficiency
• Strong written and verbal English communication; organizational and problem‑solving skills
• Effective time and financial management; ability to build relationships with stakeholders