Jobs at Poste Italiane in United States

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.

The CRA is responsible for ensuring that the conduct of clinical trials at selected investigational sites complies with the approved protocol, ICH GCP guidelines, SOPs, and applicable laws and regulations. The CRA acts as the primary communication link between the Sponsor, Investigators, and study personnel, maintaining successful working relationships. The key responsibility is to protect subjects' rights and ensure that collected data are accurate, complete, and verifiable from source documents.

• Ensure compliance with the company's Quality and Information Security Management Systems, ICH GCP, local and international legislation, including data protection laws.
• Report deviations from protocols or regulations to the Line Manager and relevant roles.
• Conduct pre-study visits to evaluate investigational sites' resources and facilities.
• Collaborate with Regulatory Affairs and Clinical Operations for submissions and contracts.
• Explain study purposes and procedures to Investigators; train and assist them in trial conduct.
• Maintain and update clinical trial documentation and ensure proper collection of essential documents.
• Manage study medication supplies, verify drug accountability, and oversee safe shipment, storage, and disposal.
• Perform monitoring visits to ensure Investigator compliance, verify data accuracy, and confirm informed consent is obtained.
• Ensure proper reporting of safety information and AE/SAE training for Investigators.
• Coordinate submissions to IEC/IRB and regulatory authorities.
• Manage drug accountability and proper dispensing.
• Document monitoring activities and communicate with Investigators.
• Participate in study meetings, provide feedback, and prepare for audits or inspections.
• Assist in site feasibility, screening, and selection.
• Support financial aspects, including Investigator payments.
• Manage subject enrollment and data quality.
• Evaluate patient recruitment and operational procedures.
• Close study sites after trial completion.
• Participate in departmental planning and SOP development.
• Provide coaching and mentorship to new or less experienced CRAs.

• Bachelor’s and/or Master’s degree, preferably in Health Sciences.
• Certified CRA.
• 6-12 months of CRA work experience.
• Fluent in English and Italian (oral and written).
• Attendance at an ICH GCP training course (desirable).
• Good computer and communication skills.
• Strong organizational skills and ability to work independently and in teams.
• Effective communication skills, diplomatic and clear.
• Ability to handle stressful situations, manage multiple issues, and work within SOPs and regulations.
• Willingness to travel frequently, including international trips, evenings, and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals at the forefront of clinical research in a friendly environment. We offer a competitive remuneration package.

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