Job Title: Clinical Study Monitor – Companion Diagnostics (CDx)
Company: Natera
Location: San Carlos, CA, USA (Remote)
Compensation: $98,400 to $123,000 per year
Benefits Offered: Dental, Life, Medical, Retirement, Vision
Position Summary:
The Clinical Study Monitor for Companion Diagnostics (CDx) is responsible for managing and overseeing the day-to-day execution and monitoring of clinical studies related to in vitro diagnostic (IVD) devices, particularly companion diagnostics developed with pharmaceutical and consortia partners. This role ensures clinical performance studies are conducted per the protocol, applicable regulations (e.g., IVDR, GCP, FDA), and company SOPs. The position requires collaboration with cross-functional teams to support study site compliance and data quality.
Key Responsibilities:
Serve as the primary point of contact for assigned study sites, ensuring study compliance, subject safety, and high-quality data collection.
Oversee monitoring activities at diagnostic laboratories, including review of essential documents and source data verification (SDV).
Monitor adherence to clinical protocols, regulatory requirements (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 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 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:
Education: Bachelor's degree in life sciences, nursing, or related field (advanced degree preferred).
Experience: 3–5 years in clinical research, with at least 2 years in IVD or CDx studies.
Regulatory Knowledge: Strong knowledge of GCP, ISO 20916, IVDR, and FDA regulations (21 CFR Part 812).
Specialization: Experience in oncology, molecular diagnostics, or precision medicine preferred.
Travel: 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.
Clinical research certification (ACRP-CP, CCRA, CCRP).
Prior experience in regulated diagnostic or medical device environments.
Knowledge, Skills & Abilities:
Strong organizational and project management skills.
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 documents, and laboratory procedures.
Comfortable in a cross-functional, fast-paced, and regulated environment.
Compensation and Benefits:
Natera offers competitive benefits, including comprehensive medical, dental, vision, life insurance, and retirement plans. Additional benefits include free testing for employees and their immediate families, fertility care benefits, pregnancy and baby bonding leave, and more.
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full-time
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