Clinical Research Associate (CRA)

Clinical Research Associate (CRA)

VCLS - Voisin Consulting Life Sciences

Boulogne-Billancourt, France

We are looking for a dynamic and motivated junior CRA/Clinical Study coordinator to fill a hybrid position, combining responsibilities of a Junior Clinical Research Associate (CRA) (60%) and a Clinical Trial Site Coordinator (40%). The ideal candidate will support clinical trial activities across multiple sites, ensuring compliance with GCP and study protocols, while providing hands-on coordination and data entry support at the site level.

Junior CRA position:

• Conduct feasibility and site qualification visits;
• Prepare and conduct site initiation visits, monitoring, site closure in accordance with GCP and study procedures;
• Write visit reports and contribute to study progress reports for project team and sponsor;
• Train the principal investigator and the investigational team on the study protocol, documentation, and study procedures;
• Ensure investigator adherence to GCP standards;
• Ensure adequate filing and maintenance of documents in the Investigator Site File;
• Retrieve the essential documents required for the Trial Master File;
• Monitor patient enrollment progress and follow up on site performance and inclusions;
• Oversee materials and products in the sites, including returns of materials;
• Perform source data verification and ensure the accuracy and quality of collected data;
• Support regulatory document reviews as part of EU legal representation activities.

Clinical trial site coordinator position:

• Act as the primary contact between the Sponsor or CRO and the site;
• Track patient enrollment and actively support the site in achieving enrollment goals;
• Perform accurate and timely data entry into study specific eCRF and address queries promptly;
• Maintain study specific and general tracking of documents at the site level;
• Manage site-specific documentation and maintain regulatory compliance at the site level;
• Assist in scheduling and preparing for monitoring visits, audits, and inspections.

Requirements

• Bachelor’s degree in Life Sciences/Health/Pharmacy;
• Mastery of GCP/ISO14155 (valid certification required) and regulations in force;
• Operational field experience: At least 1-year experience as CRA or combination of CRA and other clinical research relevant experience;
• Excellent organizational and multitasking abilities;
• Strong interpersonal and communication skills to engage with site staff and sponsors effectively;
• Proficiency in data entry and familiarity with eCRF systems;
• Problem-solving mindset and attention to detail.

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