Clinical Research Associate

Change people’s lives and love what you do Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives.

Location:
Mechelen, Belgium Help Bring the Gift of Hearing to More People Around the World We're looking for a Clinical Research Associate (CRA) to join our Clinical Operations team in Belgium. If you're passionate about clinical research, quality, and improving patient outcomes through innovative medical technology, this is an opportunity to make a real impact. As a CRA, you'll play a critical role in the successful delivery of clinical investigations that support the development of life-changing hearing solutions. You'll work alongside Clinical Project Managers, investigational sites, and global cross-functional teams to ensure studies are conducted with the highest levels of quality, compliance, and scientific excellence. What You'll Be DoingNo two days are the same in this role. You'll be involved in clinical studies from start-up through close-out, helping ensure every study is conducted safely, efficiently, and in compliance with global regulatory requirements. Lead Site Monitoring Activities* Conduct Site Initiation, Monitoring, and Close-Out Visits across clinical investigation sites.
* Partner with investigators and site teams to ensure study success.
* Deliver training on protocols, procedures, and Good Clinical Practice (GCP).
* Build strong, collaborative relationships with study sites and stakeholders.
* Support risk-based monitoring activities and drive timely follow-up on findings and actions. Drive Compliance and Quality* Ensure studies comply with ICH-GCP, ISO 14155, EU MDR, GDPR, 21 CFR, and internal quality standards.
* Review study documentation and verify adherence to protocols and regulations.
* Maintain accurate and inspection-ready Trial Master Files (TMF/eTMF) and Investigational Site Files (ISF).
* Support ethics submissions, regulatory reporting, audits, and quality reviews. Support Clinical Operations* Contribute to study start-up and ongoing operational activities.
* Coordinate with vendors, CROs, and internal teams.
* Support clinical systems, including EDC, CTMS, and eTMF platforms.
* Assist with study budgets, purchase orders, site payments, and project administration.
* Participate in data collection and post-market clinical follow-up activities where applicable. Contribute to Continuous Improvement* Participate in internal and external audits.
* Help identify opportunities to improve processes and ways of working.
* Share ideas that enhance quality, efficiency, and the overall clinical research experience. What You'll BringWe're looking for someone who combines scientific curiosity with strong organisation, attention to detail, and a passion for delivering high-quality clinical research. Essential* Bachelor's degree or higher qualification in Life Sciences or a related field.
* Understanding of clinical research processes and clinical trial operations.
* Knowledge of medical terminology.
* Strong Microsoft Office skills.
* Excellent communication and interpersonal skills.
* Ability to work independently while managing multiple priorities.
* Professional fluency in English.
* Willingness to travel locally and internationally as required. Nice to Have* CRA accreditation or certification.
* Experience within clinical research, medical devices, pharmaceuticals, CROs, or healthcare.
* Knowledge of ISO 14155, EU MDR, 21 CFR, ICH-GCP, and GDPR.
* Understanding of Ethics Committee or Institutional Review Board processes.
* Exposure to eTMF, CTMS, or Electronic Data Capture systems. Why Cochlear?At Cochlear, you'll do more than build a career. You'll help transform lives.

We offer
* Purposeful work that directly impacts people living with hearing loss.
* Exposure to global clinical research programs and cutting-edge medical technology.
* Opportunities to learn, grow, and develop within an international organisation.
* Flexible working arrangements and a collaborative team culture.
* A workplace that values innovation, inclusion, quality, and continuous improvement. Ready to Make a Difference?If you're excited by the opportunity to contribute to innovative clinical research and help bring life-changing hearing solutions to people around the world, we'd love to hear from you.Apply today and join us in helping people connect to a world of sound.

What we offer
An attractive remuneration package and flexible extra-legal benefitsAn extensive onboarding and training programAn enjoyable work environment with attention to life-work balance and homeworkingA stimulating environment with growth opportunities and opportunity to meet multi-disc