Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care. Backed by Lightspeed and Sequoia.
About the role
Serve as the primary point of contact for testing sites, ensuring protocol compliance, subject safety, and data quality align with GCP, FDA, and IVDR requirements. Execute monitoring activities based on the study-specific plan, including source data verification (SDV), essential document review, specimen tracking, and resolving sample handling issues. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- BA/BS degree in life sciences, nursing, or a related field (advanced degree such as MS or MPH is a plus)
- Minimum of 4 years of clinical research experience, including at least 2 years monitoring IVD and/or CDx studies
- Strong knowledge of GCP, ISO 20916, IVDR, and/or FDA regulations (21 CFR Part 812) relevant to diagnostic studies
- Working knowledge of diagnostic laboratory operations
- Ability to travel up to 40% for site visits, audits, and investigator meetings
- Must pass a post-offer criminal background check
More about this role
Position Summary: The Clinical Study Monitor oversees the day-to-day execution and monitoring of clinical studies involving in vitro diagnostic (IVD) devices, focusing on companion diagnostics (CDx) developed with pharmaceutical and academic partners. You will ensure studies meet protocol, company SOPs, and regulatory requirements (ICH-GCP, FDA, IVDR) while prioritizing data quality, subject safety, and inspection readiness.
At Natera, we remember there is a person behind every sample . We operate with urgency and scientific rigor to get meaningful products into the hands of clinicians and patients . This role works closely with Clinical Affairs leadership and cross-functional teams to drive study site compliance. You need a deep understanding of diagnostic lab operations and CDx studies, and the urgency to drive quality data without waiting for perfect structure.
Serve as the primary point of contact for testing sites, ensuring protocol compliance, subject safety, and data quality align with GCP, FDA, and IVDR requirements.
Execute monitoring activities based on the study-specific plan, including source data verification (SDV), essential document review, specimen tracking, and...
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