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Clinical Research Coordinator
vor 3 Monaten
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.