Clinical Research Associate I (CRA I) – Italy

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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

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- 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 escalation 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

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- 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?

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- 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. xysqume

- Build a long-term career within clinical research.

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📌 Clinical Research Associate I (Bologna)
🏢 Warman O'Brien
📍 Bologna