Clinical Study Monitor - Companion Diagnostics

Summary

Join Natera, a global leader in cell-free DNA (cfDNA) testing, as a Clinical Study Monitor – Companion Diagnostics (CDx). You will oversee the day-to-day execution and monitoring of clinical studies involving in vitro diagnostic (IVD) devices, ensuring compliance with protocols, regulations, and company SOPs. This role involves working closely with cross-functional teams, including study team members, Quality and Clinical Affairs, to support study site compliance and data quality. The ideal candidate is a proactive, detail-oriented clinical professional with a strong understanding of CDx development and diagnostic laboratory operations.

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

• Experience in oncology, molecular diagnostics, or precision medicine is strongly preferred
• 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

Benefits

• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Additionally, 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!