Clinical Research Associate 2 – FSO Model – Home Based Italy

Be the connection between science and solutions. In this CRA position, you’ll help transform complex clinical protocols into real-world results, working alongside a team that values precision, integrity, and progress. This role will offer you the opportunity to directly influence the success of global clinical trials and the delivery of innovative therapies to patients worldwide. You would be involved in a variety of indications like Oncology, Dermatology, Respiratory, Cardiology, Diabetes and others.

Key Responsibilities:

• Manage clinical trial sites in alignment with Fortrea SOPs, ICH-GCP, project plans, and sponsor requirements, including oversight of training documentation and regulatory compliance.
• Conduct all phases of site monitoring visits (pre-study, initiation, routine, and close-out), ensuring subject safety, protocol adherence, and data integrity.
• Perform source data verification, query resolution, and eCRF review to ensure high-quality, audit-ready clinical data.
• Maintain and update essential documents in eTMF and sponsor systems, ensuring regulatory and documentation completeness throughout the study lifecycle.
• Monitor investigational product (IP) accountability, storage, and compliance with protocol and regulatory standards.
• Collaborate with cross-functional teams to align site performance with study timelines, metrics, and quality expectations.

Required Qualifications :

• University or college degree in life sciences, nursing, pharmacy, or a related allied health profession; equivalent relevant experience may be considered in lieu of formal education.
• CRA Certification as per Ministerial Decree of 15 November 2011.
• Solid understanding of ICH-GCP guidelines and local regulatory requirements governing clinical research.
• Working knowledge of clinical trial processes and monitoring procedures.
• Strong attention to detail and ability to follow complex protocols and documentation standards.
• Fluent in Italian and in English both written and verbal.
• Proficient in using clinical systems and tools; able to work independently and travel as required.

Why Join Us?

• Contribute to advancing innovative therapies and improving patient outcomes through meaningful clinical research on a global scale.
• Thrive in a collaborative environment that values continuous learning, mentorship, and professional development.
• Work with modern clinical technologies and streamlined systems that support efficiency, quality, and compliance.
• Benefit from a flexible work model, competitive benefits, and a strong commitment to employee well-being.

We invite qualified candidates who are committed to excellence in clinical research to apply and become part of Fortrea’s mission to advance healthcare worldwide. If you are seeking a rewarding opportunity within a globally respected organization, we encourage you to submit your application today.

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