Clinical Study Monitor – Companion Diagnostics (CDx)

Clinical Study Monitor – Companion Diagnostics (CDx)
Position Summary
The Clinical Study Monitor – Companion Diagnostics (CDx) is responsible for overseeing the day-to-day execution and monitoring of clinical studies involving in vitro diagnostic (IVD) devices, with a focus on companion diagnostics developed in collaboration with pharmaceutical and consortia partners. This role ensures that clinical performance studies are conducted in accordance with the protocol, applicable regulations (e.g., IVDR, GCP, FDA), and company SOPs.
The Study Monitor will work closely with cross-functional teams including study team members, Quality and Clinical Affairs to support study site compliance and data quality. This position is ideal for a proactive, detail-oriented clinical professional with a strong understanding of CDx development and the workings of a diagnostic laboratory. 
Key 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.
Qualifications
•    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.
•    Experience in oncology, molecular diagnostics, or precision medicine is strongly preferred.
•    Ability to travel up to 25–40% for site visits, audits, and investigator meetings.
Nice to Have
•    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.
Knowledge, Skills & Abilities
•    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.

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$98,400—$123,000 USD

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease ma