Clinical Research Associate

Clinical Research Associate.

Clinical Research Associate

Eindhoven

|

€55000 - €65000 per year

|

Permanent

|

Clinical Research/Operations

Title: Clinical Research Associate

Reporting To: CMO

Industry: Life Sciences - Medical Devices

At Darwin Recruitment, we are excited to be partnered with a leading medical technology company focused on cutting-edge neuro therapies. Recognized by the United States Food and Drug Administration (FDA) with Breakthrough Device Designation, they are committed to accelerating access to life-changing treatments.

Position Overview:

We are helping this company recruit an experienced Clinical Research Associate who will be part of the clinical team. You will be working on clinical studies and the various stages of these. Your role is crucial to ensuring successful conduct of clinical trials and youll be required to maintain high standards of quality, compliance and the safety of patients.

Your Responsibilities:

Your responsibilities include but not limited to the following:

  • Develop and/or review study documents to ensure compliance with local and national clinical study requirements.
  • Support regulatory submissions and site start-up activities, including preparing study materials.
  • Monitor the study throughout its duration, conducting regular visits to study sites.
  • Review completed study case report forms (CRFs) and validate source documentation for accuracy.
  • Maintain accurate and up-to-date study documentation, including trial master files (TMF) and study binders.
  • Ensure timely and compliant documentation and reporting to Regulatory Authorities and Ethics Committees/Institutional Review Boards (e.g., adverse event and device deficiency reporting).
  • Ensure compliance with applicable local and national regulations, including GDPR, GCP, company SOPs, study protocols, and relevant manuals.

Your Profile:

  • Bachelors or Masters Degree in Life Sciences
  • Have a minimum of 2 years of experience in a similar role
  • Fluent in English and Dutch
  • Knowledge of GCP (ICH and ISO14155) and Clinical Research laws and regulations
  • Ideally knowledge of Clinical Research projects with medical devices
  • Excellent communicator and happy communicating with a range of stakeholders

Please apply or email james.allen@darwinrecruitment for more information.

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

James Allen

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