Clinical Research Associate

Terumo Europe; Leuven; Hybrid; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Professional growth opportunities

Collaborative team environment

Flexibility in work

Job summary

A global healthcare leader is seeking a Clinical Research Associate (CRA) in Leuven. In this role, you will oversee clinical trials and ensure compliance with protocols. The ideal candidate holds a Master's degree in Life Sciences and has proven experience in clinical trials, preferably in medical devices. Flexibility and autonomy are offered within a mission-driven organization focused on patient outcomes.

Qualifications

• Proven experience in clinical trials, preferably in medical devices.
• Experience in Oncology, Cardiology, or Peripheral Vascular Disease.
• Fluency in English; knowledge of another European language preferred.
• Willingness to travel up to 50%.

Responsibilities

• Ensure compliance with clinical study protocols.
• Conduct site management and monitor data integrity.
• Prepare documentation and reports for clinical trials.

Skills

Attention to detail

Communication skills

Integrity

Team collaboration

Education

Master’s degree in Life Sciences

Job description

Join to apply for the Clinical Research Associate role at Terumo Europe.

Overview

At EMCD, we are a dynamic, integrated scientific team committed to generating, interpreting, and sharing high-quality clinical evidence. Our mission is to support both internal and external stakeholders with the ultimate goal of improving patient outcomes. As part of a global leader in healthcare, we operate from the EMEA headquarters of a prominent Japanese corporation, bringing innovation and excellence to every clinical endeavor.

Job Summary

As a Clinical Research Associate (CRA), you will play a pivotal role in the execution and oversight of clinical trials. Acting as the bridge between the study sponsor and clinical sites, you will ensure the ethical and efficient conduct of studies, safeguard patient safety, and uphold data integrity and regulatory compliance. From study start-up to close-out, your contributions will be vital to the success of our clinical programs. This position reports to the Clinical Program Manager IO, Florence Chow.

Job Responsibilities

• Study Preparation & Conduct: Support documentation, contribute to protocol and plan development, manage CTMS entries, and assist in audit readiness.
• Site Management & Monitoring: Conduct feasibility, initiation, follow-up, and close-out visits; ensure protocol adherence and subject safety.
• Regulatory Compliance: Ensure compliance with MDR, ISO-14155, GDPR, GCP, and local regulations; assist with submissions to Ethics Committees and Authorities.
• Data Integrity & Safety Monitoring: Perform source data verification, track discrepancies, and monitor adverse events.
• Communication & Collaboration: Liaise with sponsors, sites, and regulatory bodies; foster strong site relationships and collaborate with cross-functional teams.
• Documentation & Reporting: Maintain essential documents in eTMF, prepare visit reports, and contribute to clinical investigation reports.
• General: Adhere to SOPs, represent the company professionally, and provide periodic updates to management.

Profile description

• Master’s degree in Life Sciences or equivalent experience in a CRA role.
• Proven experience in clinical trials; medical device experience is a strong plus.
• You have worked on studies in Oncology, Cardiology, or Peripheral Vascular Disease.
• Strong integrity, attention to detail, and understanding of data protection regulations
• Comfortable working in an international environment, able to navigate the complexity of a multinational organisation.
• Fluent in English; knowledge of an additional European language is preferred
• Self-directed with the ability to work independently, combined with good communication skills to keep your internal stakeholders updated.
• Willingness to travel up to 50%
• Located in Belgium, able to come to the office in Leuven at least 2 days per week.

We offer

• A meaningful role in a mission-driven organization focused on patient outcomes
• The opportunity to work on impactful clinical studies in a global setting
• A collaborative and supportive team environment
• Professional growth and development opportunities
• Flexibility and autonomy in your work