Clinical Study Monitor - Companion Diagnostics

Summary

Join Natera as a Clinical Study Monitor – Companion Diagnostics (CDx) and oversee the day-to-day execution and monitoring of clinical studies involving in vitro diagnostic (IVD) devices, focusing on companion diagnostics. Ensure clinical performance studies adhere to protocols, regulations (IVDR, GCP, FDA), and company SOPs. Collaborate with cross-functional teams to maintain study site compliance and data quality. This role requires strong understanding of CDx development and diagnostic laboratory operations. The ideal candidate will be proactive, detail-oriented, and possess excellent communication skills. This position offers the opportunity to contribute to the advancement of personalized genetic testing and diagnostics.

Requirements

• Bachelor’s degree in life sciences, nursing, or a related field; advanced degree (e.g., MS, MPH) is a plus
• 3–5 years of experience in clinical research, with at least 2 years of experience in monitoring IVD or CDx studies
• Strong knowledge of GCP, ISO 20916, IVDR, and/or FDA regulations (21 CFR Part 812) relevant to diagnostic studies
• Ability to travel up to 25–40% for site visits, audits, and investigator meetings
• Strong organizational and project management skills with the ability to manage multiple studies or sites
• Excellent written and verbal communication skills, with the ability to build rapport with internal and external stakeholders
• High attention to detail and problem-solving mindset to proactively identify and mitigate study risks
• Ability to interpret complex clinical protocols, regulatory guidance documents, and laboratory procedures
• Comfortable working in a cross-functional, fast-paced, and highly regulated environment

Responsibilities

• Serve as the primary point of contact for assigned study sites to ensure study compliance, subject safety, and high-quality data collection
• Oversee monitoring of studies conducted at a diagnostic laboratory including the review of essential documents and source data verification (SDV)
• Monitor adherence to clinical protocols, regulatory requirements (e.g., IVDR, FDA 21 CFR Part 812), and Good Clinical Practice (GCP)
• Track and resolve protocol deviations, data queries, and sample handling issues, escalating as necessary
• Collaborate with Clinical Operations, Regulatory Affairs, and Quality Assurance to ensure alignment across all study activities
• Assist in the development and review of study documents, including protocols, monitoring plans, case report forms (CRFs), informed consent forms (ICFs), and site training materials
• Monitor sample logistics, including the collection, shipment, and processing of biological specimens for CDx testing
• Support audit readiness and contribute to regulatory submissions by providing monitoring summaries and site status reports
• Participate in vendor and CRO oversight activities, including performance tracking and issue resolution

Preferred Qualifications

• Familiarity with companion diagnostic co-development with pharmaceutical partners
• Experience with electronic data capture (EDC) systems, CTMS, and sample tracking platforms
• Certification in clinical research (e.g., ACRP-CP, CCRA, CCRP) is preferred
• Prior experience working in a regulated diagnostic or medical device environment
• Experience in oncology, molecular diagnostics, or precision medicine is strongly preferred

Benefits

• Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more
• We also offer a generous employee referral program!