Clinical Research Associate

1 day ago

United States Natera Full-time
  • Oversees day-to-day execution and monitoring of clinical studies for IVD devices focusing on companion diagnostics.
  • Ensures studies meet protocol, SOPs, and regulatory requirements while prioritizing data quality and subject safety.
Primary Responsibilities:
  • Execute monitoring activities including source data verification, essential document review, and specimen tracking.
  • Prepare clear monitoring visit reports and track findings through resolution.
  • Support IRB/EC submissions and manage Trial Master File documentation.
Qualifications:
  • BA/BS in life sciences or related field with 4+ years clinical research experience.
  • Strong knowledge of GCP, ISO 20916, IVDR, and FDA regulations.
  • Ability to travel up to 40% for site visits and audits.
Natera

Natera is a global leader in cell-free DNA testing dedicated to oncology, women's health, and organ health. The team consists of highly dedicated professionals from world‑class institutions who care deeply for their work and each other.

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