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Senior Clinical Research Associate

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Lazio

Ibrido

EUR 40.000 - 60.000

Tempo pieno

Ieri

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Descrizione del lavoro

A global clinical research organization seeks a Clinical Research Associate to manage sites across Italy. This remote/hybrid role involves conducting site visits and ensuring compliance with regulatory standards. Candidates should have a relevant Bachelor's degree, CRA experience, and strong organizational skills.

Servizi

Very competitive salary and benefits package

Flexible, remote/hybrid work structure

Exposure to complex studies in high-impact therapeutic areas

Supportive team culture with close collaboration

Tools, training, and operational support for quality monitoring

Competenze

Need at least 3 years of CRA experience, ideally with exposure to oncology.
Fluency in Italian and English is necessary.
Strong knowledge of Italian regulatory requirements and ICH-GCP guidelines.

Mansioni

Conduct pre-study, initiation, monitoring, and close-out visits to ensure compliance.
Manage site staff training and site documentation oversight.
Ensure SAE and safety compliance while maintaining site adherence to protocols.

Conoscenze

Independence

Communication

Regulatory Knowledge

Organizational Skills

Proactivity

Formazione

Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline

Direct message the job poster from AL Solutions

Clinical Operations Specialist at AL Solutions

Clinical Research Associate – Italy

Location: Rome or Bologna (Field-based with flexibility)

Chloe O'Shea is partnering with a mid-sized, global clinical research organization (CRO) known for its hands-on, personalized approach to trial delivery. This CRO supports a wide range of complex and innovative studies, offering CRAs the chance to work closely with both cross-functional teams and sponsors in a collaborative and agile environment.

We’re currently looking for an experienced Clinical Research Associate (CRA) to join an established Italian team, supporting studies across oncology and rare diseases. This is a home-based role (with flexibility for hybrid) requiring around 6–8 site visits per month, offering balance, autonomy, and meaningful involvement in impactful trials.

The Role

As a CRA, you’ll play a critical role in managing and monitoring clinical sites across Italy. Working with a supportive international team and local colleagues, you’ll ensure compliance with regulatory standards and protocols, while maintaining strong relationships with site staff and sponsor partners.

Key Responsibilities

Conduct pre-study, site initiation, monitoring, and close-out visits, ensuring compliance with protocols, SOPs, and regulatory requirements.
Support site staff training, manage site documentation, and oversee completeness and accuracy of site files.
Perform SDV, review informed consent, monitor drug accountability, and ensure SAE and safety compliance.
Track eCRF entries, follow up on queries, and monitor site adherence to protocol and GCP standards.
Maintain oversight of study supplies and documentation, and follow up on quality findings and audit responses.

Requirements

Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline.
Minimum 3 years of independent CRA experience, ideally with exposure to oncology; rare disease experience is a plus.
Strong knowledge of Italian regulatory requirements and ICH-GCP guidelines.
Ability to manage sites across multiple phases and therapeutic areas.
Fluent in Italian and English (written and spoken).
Proactive, well-organized, and comfortable working independently and within a team.

What’s in It for You?

Very competitive salary and benefits package
Work within a flexible, remote/hybrid structure
Exposure to complex studies in high-impact therapeutic areas
Supportive team culture with close collaboration across functions
Tools, training, and operational support to perform high-quality monitoring

If you're an experienced CRA based in Rome or Bologna and looking for a fresh challenge within a CRO that values quality, ownership, and flexibility, we’d love to speak with you.

Apply now or reach out directly to discuss this role in more detail.

Seniority level

Associate