Clinical Research Associate
Terumo EuropeAbout the role
At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations.
Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for
Department Info
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.
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
Contact Person
Jan Swinnen
Working at Terumo means advancing healthcare with heart. Here, you are empowered to grow your own way, inspired to create to innovate, and supported as we get there together. Join us in shaping a healthier future for our patients, society, and each other.
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