Clinical Research Associate

Heads, a global CRO and part of Veeda Lifesciences, is seeking a Clinical Research Associate (CRA) based in Italy for its expanding international hematology/oncology clinical trials program.

This is a full-time position.

Job overview :

The CRA is responsible for ensuring that the conduct of a clinical trial at selected investigational sites complies with the approved protocol/amendments, ICH GCP guidelines, SOPs, and applicable laws and regulations.

He/she is the primary contact for operational study activities between the Sponsor, Investigators, and study personnel, fostering successful relationships.

The key responsibility is to ensure subjects’ rights are protected and that all clinical trial data are accurate, complete, and source-verifiable.

Main responsibilities :

• Ensure compliance with the company’s Quality and Information Security Management Systems, ICH GCP, local and international legislation, including data protection laws, and update adherence accordingly.
• Report deviations from protocols, GCP guidelines, or legislation to the Line Manager and relevant roles per SOPs.
• Conduct pre-study visits to evaluate investigational sites’ resources and facilities.
• Collaborate with Regulatory Affairs and Clinical Operations for submissions, contracts, and approvals, including hospital IEC submissions and study contracts.
• Explain study purposes and procedures to Investigators, providing training and support.
• Maintain and update clinical trial files, ensuring proper documentation and collection of essential documents.
• Supply sites with study medication, verify drug accountability, and oversee proper shipment, storage, dispensing, and disposal.
• Monitor clinical trial conduct through site visits, verifying investigator qualifications, data accuracy, and compliance with protocols and GCP.
• Verify informed consent procedures, monitor recruitment timelines, and ensure proper storage of trial supplies.
• Maintain Investigator Files, report safety information, and ensure timely submissions to IEC/IRB or regulatory authorities.
• Manage drug accountability, prepare monitoring reports, and participate in study meetings.
• Assist in audits or inspections, preparing sites and facilitating corrective actions.
• Support feasibility assessments, site selection, and study enrollment management.
• Participate in planning, SOP development, and provide coaching to less experienced CRAs.

Job Requirements :

• Bachelor’s or Master’s degree in Health Sciences preferred.
• Certified CRA.
• 6-12 months’ CRA experience.
• Fluent in English and Italian, both oral and written.
• Experience with ICH GCP training (desirable).
• Proficient in computer skills and good communication, organizational, and interpersonal skills.
• Ability to work independently and as part of a team.
• Effective communication skills, diplomatic and clear.
• Ability to handle stressful situations, flexible timelines, and multitask.
• Ability to adhere to SOPs, guidelines, and ethical principles.
• Willingness to travel domestically and internationally, including overnight stays.

Join our multidisciplinary team of skilled scientists and healthcare professionals in a friendly environment.

Competitive remuneration package available.

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