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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 ICH-GCP requirements.
A degree in life sciences, pharmacy, nursing, medicine or another relevant discipline.
Fluent Italian and strong professional English.
Currently based in Italy.
Willingness and ability to travel regularly to investigative sites across Italy.
Strong organisational, communication and report-writing skills.
Ability to manage multiple priorities and work effectively with limited supervision.
A valid driving licence is preferred.
Why Consider This Opportunity?
Develop your independent clinical monitoring experience.
Support clinical trials within an international CRO environment.
Work closely with experienced clinical operations professionals.
Vantaggi from ongoing training and professional development.
Build a long-term career within clinical research. xdwybme
If you are based in Italy and would be interested in developing your career as a Clinical Research Associate, please apply or get in touch for a confidential discussion.
📌 Clinical Research Associate I (Roma)
🏢 Warman O'Brien
📍 Roma
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