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Clinical Study Monitor
Natera Remote Posted 23 hours ago
About the 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.
What you'll do
- 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.
- Drive the operational execution of clinical studies, from start-up and site qualification through routine monitoring and close-out.
- Prepare clear, objective monitoring visit reports, tracking site findings, protocol deviations, and CAPAs through to resolution.
- Take ownership of developing study-related documents, relying on strong judgment to move work forward even when standard processes are still being built.
- Collaborate across Clinical Operations, Regulatory Affairs, and Quality Assurance to align on study execution and quality expectations.
What you'll need
Natera lists the full requirements on its posting.