Senior Clinical Research Associate - Oncology, Hematology - Italy

Make An Impact As A Clinical Research Associate At Worldwide

As a Clinical Research Associate at Worldwide, you'll play a critical role in ensuring the quality, integrity, and success of clinical trials. By partnering closely with investigative sites, study teams, and sponsors, you'll help drive high-quality data collection while supporting patient safety and regulatory compliance throughout the clinical research process.

In this role, you'll take ownership of site management activities across the study lifecycle, from feasibility and site initiation through monitoring and close-out. Your expertise will contribute to the successful delivery of clinical research programs while building strong relationships with site personnel and cross-functional teams.

You'll also have the opportunity to provide guidance to colleagues, contribute to study planning activities, and support operational excellence across global clinical trials.

Where You'll Work

This is a home-based Clinical Research Associate role supporting sites across Italy. Candidates must reside within the territory to effectively support site visits and study activities. You will collaborate with sites, sponsors, and global study teams while traveling to investigative sites approximately 6-8 days per month.

To best support our sites, we're seeking candidates who are based in Italy. Travel will primarily be national, with occasional travel to support sites in other locations as needed.

What You'll Do

• Conduct site qualification, initiation, monitoring, and close-out visits in accordance with protocol requirements, GCP, and applicable regulations.
• Assess site performance and provide training and guidance to site personnel to promote protocol adherence, data quality, and patient safety.
• Perform source document verification and review study data to ensure accuracy, completeness, and compliance.
• Support regulatory and ethics documentation activities, ensuring study files remain inspection-ready and up to date.
• Partner with study teams and project management to track study progress, support milestones, and drive successful trial execution.
• Maintain strong relationships and regular communication with investigative sites, sponsors, and cross-functional stakeholders.
• Review and document site findings, support query resolution, and contribute to Trial Master File and Investigator Site File maintenance.
• Provide leadership and mentorship to less experienced CRAs and contribute to study-specific tools, training initiatives, and operational improvements.

What You'll Bring

• Medical Doctor (MD) degree or Pharmacy degree with a minimum of 3 years of Clinical Research Associate experience; OR a bachelor's degree in a life science or related field with a minimum of 5 years of CRA experience; OR a nursing/associate degree or equivalent with a minimum of 7 years of CRA experience.
• Strong clinical monitoring experience across the full study lifecycle, including site qualification, initiation, monitoring, and close-out activities.
• Thorough understanding of GCP, ICH Guidelines, FDA and/or EU regulations, and local regulatory requirements.
• Demonstrated knowledge of clinical research processes, site management practices, and regulatory documentation requirements.
• Experience working with EDC systems, IxRS platforms, and Microsoft Office applications.
• Ability to lead, mentor, and collaborate effectively with study teams, investigative sites, and cross-functional stakeholders.
• Proficiency in English and fluent Italian required, both written and spoken.
• Experience in full-service monitoring required.

Worldwide Clinical Trials