Clinical Research Associate

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

As a Clinical Research Associate (CRA), you will be responsible for monitoring clinical studies and ensuring compliance with study protocols, ICH-GCP guidelines, and regulatory requirements. You will act as a key liaison between study sites and project teams, contributing to the successful execution of oncology clinical trials.solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

Key Responsibilities

• Review study protocols and provide operational feedback regarding site implementation and study feasibility.
• Contribute to the development of study documentation, including CRFs, monitoring guidelines, investigator brochures, and study materials.
• Collect and review all site documentation required for study start-up activities.
• Plan and perform site initiation, monitoring, and close-out visits, and prepare corresponding monitoring reports.
• Verify the accuracy and quality of clinical trial data and ensure compliance with study protocols and ICH-GCP requirements.
• Ensure proper management of investigator and pharmacy files, including filing and archiving activities within study documentation systems.
• Follow up on Serious Adverse Event (SAE) reporting and ensure site compliance with safety requirements.
• Communicate protocol-related information to investigational sites and support site teams throughout the study lifecycle.
• Act as a key liaison between study stakeholders, investigators, and clinical research teams while promoting Good Clinical Practices.
• Maintain study tracking tools and report site issues, risks, and improvement opportunities to the project team.
• Stay up to date with relevant medical, scientific, and pharmacological knowledge.
• Report regularly to the CRA Manager on study progress and site-related activities.

Requirements

• Strong experience in clinical trial monitoring.
• Significant experience in interventional clinical studies, preferably involving investigational medicinal products.
• Good understanding of the pharmaceutical industry environment and sponsor expectations.
• Experience in oncology and/or hematology is considered a strong asset.
• Experience working on complex clinical studies and/or high patient-enrollment studies is highly desirable.

Benefits

Why join us?

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

Here's what makes us unique:

We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience.

Our "one-stop provider" service model-combining full-service, functional service provider, and consulting-allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.

Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.