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Clinical Research Coordinator

vor 3 Monaten


Dortmund, Nordrhein-Westfalen, Deutschland Implantica Vollzeit

Implantica Group

Implantica is a pioneering medtech organization committed to integrating advanced technology within the human body. Our flagship product, RefluxStop, is a CE-marked implant designed to prevent gastroesophageal reflux, potentially revolutionizing anti-reflux treatment, as evidenced by successful clinical trial outcomes. Additionally, Implantica is dedicated to eHealth innovations and has developed a comprehensive, patent-protected product pipeline based on two core technologies: an eHealth platform for monitoring various health metrics, managing treatments internally, and facilitating remote communication with caregivers, alongside a wireless energizing platform that powers remote-controlled implants through intact skin.

We are currently looking for a Clinical Trial Specialist, 100% (m/f/n)

Key Responsibilities:

  • Conduct clinical activities, including initiation visits, monitoring, ongoing site training, and safety reporting, while preparing study sites for audits.
  • Provide hands-on support to study site personnel regarding study execution and adherence to protocols and relevant guidelines.
  • Prepare, submit, and manage clinical trial ethics and regulatory submissions and approvals.
  • Assist in the creation of study documentation, such as Clinical Investigation Plans (CIP) and Informed Consent Forms (ICF).
  • Oversee study progress and compliance, reporting status updates to management.
  • Establish and maintain strong relationships with Key Opinion Leaders (KOLs) and other personnel at study sites.

Your Qualifications:

  • A Bachelor's degree in life sciences or a related discipline.
  • A minimum of 3 years in a clinical project management role or at least 5 years as a Clinical Research Associate (CRA) in the EU, preferably with experience in Medical Devices.
  • In-depth knowledge of ISO 14155, MDR, and other relevant regulations and clinical trial processes.
  • Fluency in both German and English is essential; proficiency in Italian or French is advantageous.
  • Willingness to travel to study sites up to 60%, which may include overnight travel within Europe.

What We Offer:

  • An engaging and stimulating role within a dynamic and open organization.
  • A dedicated, motivated, and international team.
  • Modern working conditions and competitive compensation.

For further information, please visit our website.