Clinical Research Associate

Veeda Lifesciences; Frosinone; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A global CRO is seeking a Clinical Research Associate (CRA) based in Italy for its expanding clinical trials. This full-time role involves ensuring compliance with protocols, conducting site visits, and managing safety reporting. The ideal candidate will have a degree in Health Sciences, CRA certification, and 6-12 months of experience. Strong communication skills in English and Italian are essential. Competitive remuneration is offered.

Servizi

Competitive remuneration package

Competenze

• 6-12 months' experience as a CRA is required.
• ICH GCP training certification is desirable.
• Willingness to travel frequently, including evenings and overnight stays.

Mansioni

• Ensure compliance with quality systems and ICH GCP guidelines.
• Conduct pre-study visits for feasibility evaluation.
• Perform monitoring visits to ensure investigator compliance.

Conoscenze

Fluent in English

Fluent in Italian

Strong communication skills

Organizational skills

Ability to work independently

Diplomatic communication with site personnel

Multitasking abilities

Formazione

Bachelor’s and/or Master’s degree in Health Sciences

Certified CRA

Strumenti

Proficient computer skills

Descrizione del lavoro

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 clinical trials at selected investigational sites complies with the approved protocol/amendments, ICH GCP guidelines, SOPs, and applicable laws and regulations. They serve as the primary communication link between the Sponsor, Investigators, and study personnel, maintaining successful working relationships. A key responsibility is to ensure the rights of subjects are protected and that all clinical data collected are accurate, complete, and verifiable from source documents.

Main responsibilities:

1. Ensure compliance with the Company’s Quality and Information Security Management Systems, ICH GCP guidelines, and relevant legislation, including data protection laws.
2. Report deviations from protocols, guidelines, or legislation during study conduct to the Line Manager and relevant roles per SOPs.
3. Conduct pre-study visits to evaluate potential investigational sites for feasibility and resources.
4. Collaborate with Regulatory Affairs and Clinical Operations for clinical submissions, contracts, and study approvals.
5. Explain study purposes and procedures to Investigators, providing training and support in trial conduct.
6. Maintain and update Clinical Trial Files, ensuring proper collection of documents.
7. Supply sites with study medication, verify drug accountability, and oversee shipment, storage, and disposal.
8. Perform monitoring visits to ensure investigator compliance, verify data accuracy, and ensure proper consent procedures.
9. Manage safety reporting, including AE/SAE reporting and safety communication.
10. Ensure timely submissions to IEC/IRB and regulatory authorities.
11. Conduct drug accountability and proper dispensing.
12. Document monitoring activities and communicate findings.
13. Participate in meetings, provide feedback, and support audit and inspection readiness.
14. Assist in site selection, feasibility, and study planning.
15. Support financial processes, including investigator payments.
16. Manage subject enrollment and data quality.
17. Evaluate patient recruitment and operational feasibility.
18. Close down study sites post-trial completion.
19. Contribute to departmental planning and SOP development.
20. Mentor and coach new or less experienced CRAs.

Job requirements:

• Bachelor’s and/or Master’s degree, preferably in Health Sciences.
• Certified CRA.
• 6-12 months’ experience as a CRA.
• Fluent in English and Italian (oral and written).
• Desirable: ICH GCP training certification.
• Proficient computer skills.
• Strong communication and organizational skills.
• Ability to work independently and as part of a team.
• Diplomatic and effective communication with site personnel.
• Ability to handle stressful situations, flexible with timelines.
• Good multitasking and adherence to SOPs, guidelines, and ethical principles.
• Willingness to travel frequently, including evenings and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals in a supportive work environment. We offer a competitive remuneration package.

We prioritize Data Protection and respect your privacy. For details on data processing, please review our Privacy Notice to Candidates.