Clinical Research Associate
1 day ago
United States
Natera
Full-time
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- 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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