Clinical Research Associate

vor 3 Wochen

Berlin, Berlin, Deutschland Una Health Vollzeit
About the Role

We are Una Health, a health tech startup on a mission to reverse metabolic dysfunction, which impacts 1 billion+ people globally, by using technology to understand our metabolism and behavior.

Key Responsibilities
  • Manage and oversee study sites, ensuring compliance with study protocols, GCP, and regulatory requirements.
  • Conduct Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV) to ensure study progress and quality.
  • Perform Source Data Verification (SDV) and ensure accurate data collection and documentation.
  • Provide ongoing support to study sites, manage queries, and ensure timely issue resolution.
  • Assist in training study personnel on study protocols and CRF completion.
  • Prepare and submit monitoring visit reports and other study-related documentation.
Requirements

Qualifications:

  • Bachelor's 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 language 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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