Clinical Research Associate I

Warman O'Brien; Bologna; Ibrido; EUR 32.000 - 45.000; Tempo pieno

Descrizione del lavoro

Warman O'Brien is seeking a Clinical Research Associate I to support clinical trials across Italy. This home-based position involves regular travel to trial sites, with a focus on developing independent site-management capabilities within an international CRO.

The successful candidate will have initial clinical research exposure, a life sciences degree, fluent Italian and strong English, and the willingness to travel across Italy to monitor sites and ensure high-quality data and study execution.

Competenze

• Experience in clinical research, preferably with site monitoring exposure.
• Strong understanding of ICH-GCP requirements and regulatory expectations.
• Degree in life sciences, pharmacy, nursing, medicine or related field.

Mansioni

• Conduct site qualification, initiation, routine monitoring and close-out visits.
• Monitor sites per study protocols, ICH-GCP and Italian/European regulations.
• Review source data and ensure accuracy and completeness of trial data.
• Maintain investigator site files and inspection-ready documentation.
• Support sites with patient recruitment, data entry and query resolution.
• Identify protocol deviations, compliance concerns and site risks.
• Prepare monitoring visit reports and follow up actions.
• Build relationships with investigators, study coordinators and site staff.
• Collaborate with Clinical Trial Managers and international teams.
• Ensure sites meet quality, recruitment and timelines.

Conoscenze

Clinical Monitoring

ICH-GCP

Site coordination

Travel readiness

Formazione

Life sciences degree

Descrizione del lavoro

Clinical Research Associate I (CRA I) – Italy

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 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

• 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.