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Clinical Research Associate

Netherlands, Gelderland, ArnhemClinical Operations

Job description

What you'll do

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!

Job requirements

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

Interested?

Getting excited about a career in the dynamic and innovating world of medical devices? Then please submit your resume and motivation!

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How we hire

We have a thorough and flexible hiring process, to ensure we make the right decision and to help you to decide if we're the right fit for you.

Screening

First of all, thank you for your interest in a career at Qserve. All applications are reviewed by our HR department in close cooperation with the respective hiring manager. If we see a potential match, you will be invited for a first interview.

Interview(s)

At this stage, we would like to take a deeper dive into your experience and what you could bring to the team. Besides that, we would love to tell you more about our company and people. You can expect several interviews with different relevant stakeholders.

Employment conditions

Are you ready to sign your contract? Our HR colleague is looking forward to informing you about the employment conditions at Qserve, both primary and secondary. Your adventure at Qserve Group officially starts here!

Onboarding

We know how important it is to provide new hires with an engaging onboarding and warm welcome. As part of the structured program, you will be introduced to representatives of all our global teams and departments.