CRA Medical Device

Excelya; Boulogne-Billancourt; Sur place; EUR 40 000 - 70 000; Plein temps

Résumé du poste

An ambitious health company is seeking a Clinical Research Associate to join their dynamic team. This role offers a unique opportunity to contribute to innovative clinical research, collaborating with experts in a stimulating environment. You'll be responsible for site selection, monitoring, and ensuring data integrity while enjoying a culture that values audacity and personal growth. If you're ready to take bold steps and make a significant impact in the healthcare sector, this position is perfect for you.

Qualifications

• Proven ability to thrive in collaborative, fast-moving environments.
• At least 3 years of experience as a Clinical Research Associate (CRA).
• Regulatory knowledge in ISO 14155 and GCP.

Responsabilités

• Qualify, select, and initiate clinical investigation sites.
• Conduct on-site and remote monitoring visits for data accuracy.
• Collaborate with the Data Manager to ensure data integrity.

Connaissances

Organizational Skills

Problem-Solving

Communication Skills

Clinical Research Associate Experience

Regulatory Knowledge (ISO 14155)

Knowledge in Oncology

Knowledge in Cardiology

Formation

Knowledge in Oncology

Description du poste

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.

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.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main responsibilities :

• Qualify, select, and initiate clinical investigation sites in collaboration with the Clinical Project Manager(s).
• Perform site close-out activities in accordance with Clinical Project Manager(s)' recommendations.
• Conduct on-site and remote monitoring visits to ensure the scientific quality and accuracy of collected data.
• Serve as the primary point of contact for investigation sites regarding clinical-related inquiries.
• Collaborate with the Data Manager and clinical team to review patient data and ensure data integrity.
• Identify non-compliances and follow up on the implementation of corrective and preventive actions.
• Contribute to study start-up and close-out administrative tasks, including the preparation of monitoring reports in English.
• Participate in project meetings, clinical procedure writing and revision, and support audit and inspection readiness.

About You

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

• Experience: Proven ability to thrive in collaborative, fast-moving environments (talent matters most to us—minimum years are not required).
• Skills: Strong organizational abilities, problem-solving mindset, and excellent communication skills. At least 3 years of experience as a Clinical Research Associate (CRA). Regulatory knowledge: ISO 14155, European Medical Device Regulation 2017 / 745. Proficient in Good Clinical Practice (GCP).
• Knowledge in cardiology and cardiac surgery is an asset.
• Education: Knowledge in Oncology is mandatory.
• Languages: Fluency in French & good level in English.