CRA - Site Start-Up Specialist (Italy)
📍 Remote | Full-time (1 FTE) | 1-year contract with possible renewal
About the Role
We are looking for an experienced Site Start-Up Specialist or Clinical Research Associate with expertise in Italian Ethics Committee submissions to join our multinational clinical operations team.
This position focuses on end-to-end start-up activities for clinical trials conducted in Italy. It is a remote, in-house role — no travel or on-site monitoring is required.
You will play a key role in ensuring efficient and compliant site activation, working closely with cross-functional and divisional study teams.
Key Responsibilities
1. Lead the end-to-end site start-up process for assigned studies in Italy.
2. Prepare, submit, and follow up on Ethics Committee (EC) submissions.
3. Customize and negotiate Informed Consent Forms (ICFs).
4. Manage essential regulatory and site documentation in compliance with GCP and local requirements.
5. Ensure timely site activation in alignment with global study timelines.
6. Collaborate closely with Clinical Trial Managers, Regulatory Affairs, and divisional study teams.
7. Maintain accurate and up-to-date tracking in systems such as Veeva CTMS and eTMF.
Requirements
8. Proven experience as a Site Start-Up Specialist or Clinical Research Associate with direct involvement in Italian EC submissions.
9. Strong understanding of Italian clinical trial regulations and documentation requirements.
10. Excellent organizational skills, attention to detail, and ability to manage multiple priorities.
11. Strong communication and collaboration skills in a cross-functional, multinational environment.
12. Fluency in Italian and English (mandatory).
13. A third European language will be considered a strong asset.
14. Availability to start as soon as possible.
Contract Details
15. Full-time (1 FTE) contingent position / B2B Contract
16. Remote work mode.
17. Duration: 1 year, with potential for renewal.
18. Multidivisional support across several therapeutic areas.
Why Join Us?
19. Opportunity to work on high-impact international studies.
20. Stable and long-term project involvement.
21. Collaboration within a global, professional clinical operations environment.
22. Remote flexibility combined with clear structure and support.