Senior CRA II - Sponsor dedicated

FTFRA Fortrea France SARL; Paris; Hybride; EUR 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Office-based or remote position

Career growth environment

Résumé du poste

Fortrea is recruiting for a Senior Clinical Research Associate II (SCRA II) in Paris. The role focuses on monitoring, site management and SDV to ensure adherence to ICH GCP and regulatory standards.

You will train investigators, support site staff, and contribute to comprehensive trial documentation while working with a leading sponsor on innovative studies.

Qualifications

• Life Sciences degree or certification in a related allied health profession.
• Thorough understanding of ICH GCP Guidelines.
• Strong knowledge of monitoring procedures and clinical trial processes.
• Fluency in English, written and verbal.

Responsabilités

• Monitor Clinical Trials - conduct site visits to ensure compliance with protocols, regulatory requirements and GCP (National on sites visits in France, 40%).
• Site Management - serve as the primary point of contact for investigational sites, ensuring smooth study operations.
• Source Document Verification (SDV) - review and verify accuracy of clinical data from study sites.
• Investigator Training and Support - provide ongoing training to site staff on study protocols and regulatory requirements.
• Reporting and Documentation - prepare monitoring reports, maintain study records, and contribute to study documentation.

Connaissances

Monitoring procedures understanding

ICH GCP knowledge

Fluent English

Formation

Life Sciences degree or related certification

Description du poste

Fortrea is recruiting! Our FSP department in Paris is looking for a Senior Clinical Research Associate II (SCRA II).

Key Responsibilities

• Monitor Clinical Trials - conduct site visits to ensure compliance with protocols, regulatory requirements and Good Clinical Practice (GCP) - National on sites visits in France (40%).
• Site Management - Serve as the primary point of contact for investigational sites, ensuring smooth study operations.
• Source Document Verification (SDV)- Review and verify accuracy of clinical data collected from study sites.
• Investigator Training and Support - Provide ongoing training to site staff on study protocols and regulatory requirements.
• Reporting and Documentation - Prepare monitoring reports, maintain study records, and contribute to overall trial documentation.

Qualifications

• Life Sciences University degree or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
• Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
• Thorough knowledge of monitoring procedures and basic understanding of the clinical trial process.
• Fluency in English, written and verbal.

What We Offer

• Office based or remote position
• Career growth environment in a supportive environment
• Dedicated Line Manager
• Works directly with a leading sponsor on innovative studies
• Attractive salary and Fortrea benefits

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