Our in-house Clinical Research Associate (CRA) is responsible for document development, ethics committee and regulatory authority submissions in the Netherlands and Belgium, (limited) on-site and remote monitoring and site management of the clinical studies we execute for our clients; the study Sponsors. Our CRO is fully medical device dedicated, which offers a very interesting, quickly changing working environment. In collaboration with the Clinical Project Manager (CPM) you develop fully ISO 14155 (GCP) and EU-MDR compliant essential study documents. You qualify, initiate and monitor sites located in the Netherlands and Belgium (limited traveling). You collaborate with and support remotely, other CRAs located all over the EU, in alignment with the CPM. You support our CTA in keeping Investigator Site Files, Trial Master Files, and other required documents compliant with applicable guidelines.
Are you an experienced, self-starting, accurate CRA, who aspires an in-house role with limited traveling obligations?
Are you interested in EU-MDR, ISO 14155 (GCP) and like to work in the medical device industry?
Then we would be pleased to receive your application!
What you’ll bring to the team
Bachelor of Science in health/medical-related field
Previous experience as a CRA
Fluent in English, German is a plus;
GCP knowledge is a must, ISO14155 is a plus;
Medical device experience and EU-MDR knowledge are a plus
Accurate, independent, pro-active team player with good communication skills
Getting excited about a career in the dynamic and innovating world of medical devices? Then please submit your resume and motivation!