Clinical Research Coordinator / Clinical Study Lead

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

A company specialized in infant nutrition is currently conducting several Phase III clinical studies evaluating the efficacy and tolerability of formulations based on natural ingredients.

To support this growing clinical activity, the organization is seeking an Clinical Research Associate capable of coordinating clinical studies and ensuring strict operational and regulatory compliance.

Main Responsibilities

1. Study Documentation & Preparation

• Contribute to writing the study synopsis, protocol, and all study‑related documents (CRF, patient information sheet, informed consent form, safety reports, clinical reports).
• Prepare and supervise regulatory submissions to competent authorities (ANSM, CPP, CNOM, and international equivalents).

2. Clinical Study Conduct

• Coordinate key trial milestones, including site selection, site initiation visits, monitoring visits, and close‑out visits in France and abroad.
• Oversee study progress, recruitment tracking, and adverse event reporting.
• Prepare periodic progress reports for internal and external stakeholders.

3. Vendor & Partner Management

• Select and manage vendors involved in study activities (logistics, coordination, data management, biostatistics, etc.).
• Coordinate contracts and payments for investigators and service providers.

4. Documentation & Data Oversight

• Manage all trial documentation and maintain study information in relevant databases (e.g., clinicaltrials.gov).
• Contribute to drafting Credit Impôt Recherche (CIR) dossiers.
• Participate in the development and update of internal SOPs.

Requirements:
About You

• Experience: Experienced as a Clinical Research Associate, preferably with experience in nutrition or related therapeutic areas.
• Skills: Able to combine operational CRA duties with project management.
• Strong understanding of clinical trial methodologies and ICH-GCP guidelines. Excellent communication and organizational skills are essential.
• Education: Bachelor’s degree in Nutrition, Life Sciences, Pharmacy, or a related field. A Master's degree or expertise in clinical nutrition is a plus.
• Languages: Proficiency in both French and English.

Benefits:
Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique—

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.