18 set - Reggio Emilia
Warman O'Brien
Clinical Research Associate I (CRA I) – Italy
La descrizione completa del lavoro illustra tutte le competenze, l'esperienza pregressa e le qualifiche che i candidati dovrebbero possedere.
Location: Italy
Working arrangement: Home-based with travel to clinical trial sites
Employment type: Full-time, permanent
The Opportunity
We are partnering with an international clinical research organisation seeking a Clinical Research Associate I to support clinical trials across Italy.
This opportunity would suit an early-career CRA who has gained initial clinical research or monitoring experience and is now looking to develop their independent site-management capabilities within an international CRO environment.
Key Responsibilities
- Conduct site qualification, initiation, routine monitoring and close-out visits.
- Monitor assigned clinical trial sites in accordance with study protocols, ICH-GCP and applicable Italian and European regulations.
- Review source documentation and verify the accuracy and completeness of clinical trial data.
- Ensure investigator site files and essential study documentation remain complete, accurate and inspection-ready.
- Support investigative sites with patient recruitment, data entry and query resolution.
- Identify and escalate protocol deviations, compliance concerns and site-level risks.
- Prepare accurate monitoring visit reports and follow up on outstanding actions.
- Build effective relationships with investigators, study coordinators and other site personnel.
- Collaborate with Clinical Trial Managers and wider international project teams.
- Ensure assigned sites meet agreed quality standards, recruitment objectives and study timelines.
Candidate Requirements
- Previous experience within clinical research, ideally including exposure to clinical site monitoring.
- Experience as a Junior CRA, CRA I, In-House CRA, Clinical Trial Assistant or in a similar clinical research position.
- A good understanding of clinical trial processes and
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