Clinical Research Associate
Vor 5 Tagen
We are Una Health, a mission-driven health tech startup tackling the growing challenge of metabolic dysfunction. Our innovative approach combines cutting-edge medical research, AI, biosensor technology, and user-centered design to develop the first digital therapy to sustainably resolve metabolic disorders.
We are seeking a highly motivated Clinical Research Associate (CRA) to join our team on a freelance basis in Bavaria, North Rhine-Westphalia, or Hesse, with travel to study centers. The project is limited to September 2025. As a CRA, you will work closely with our Medical Team and Study Coordination at the Technical University of Munich.
Key Responsibilities- Monitor and manage study centers, ensuring compliance with study protocols, GCP, and regulatory requirements.
- Conduct Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV).
- Perform Source Data Verification (SDV) and ensure accurate data collection and documentation.
- Provide ongoing support to study centers, manage inquiries, and ensure timely problem-solving.
- Assist in training study personnel on study protocols and completing CRFs.
- Prepare and submit monitoring visit reports and other study-related documentation.
Qualifications:
- Degree in Life Sciences, Medicine, or a related field.
- GCP certification (Good Clinical Practice).
Experience:
- At least 5 years of experience as a CRA (preferably in diabetes and/or digital health).
- Proven experience in managing clinical studies from initiation to completion.
Language: Excellent German and English skills in writing and speaking.
Passion: Strong motivation to drive digital health forward and contribute to innovative clinical research.
Skills and Knowledge:
- Experience with EDC systems and knowledge of CRF design and completion.
- Excellent organizational and communication skills.
- Ability to work independently and manage time effectively.
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