Clinical Study Monitor

Natera

2h • $108,200 - $140,000 • Remote

About The Position

The Clinical Study Monitor oversees day-to-day execution and monitoring of clinical studies involving in vitro diagnostic (IVD) devices, with a focus on companion diagnostics (CDx) developed with pharmaceutical and academic partners. The role ensures studies comply with protocols, company SOPs, and applicable regulatory requirements, including ICH-GCP, FDA, and IVDR, while prioritizing data quality, subject safety, and inspection readiness.

The position works closely with Clinical Affairs leadership and cross-functional teams to drive study site compliance. It calls for a strong understanding of diagnostic laboratory operations and CDx studies, along with the ability to move work forward in a fast-paced environment where processes may still be developing. This remote USA role involves up to 40% travel and duties in a hybrid or office setting when applicable, including computer use, video conferencing, and occasional non-standard hours.

Requirements

• BA/BS degree in life sciences, nursing, or a related field.
• At least 4 years of clinical research experience, including at least 2 years monitoring IVD and/or CDx studies.
• Strong knowledge of GCP, ISO 20916, IVDR, and/or FDA regulations (21 CFR Part 812) relevant to diagnostic studies.
• Working knowledge of diagnostic laboratory operations.
• Ability to travel up to 40% for site visits, audits, and investigator meetings.
• Must pass a post-offer criminal background check.
• Strong project management skills and ability to coordinate and execute multiple studies.
• Clear, direct communication skills for building trust and alignment with clinicians, partners, and internal teams.
• High attention to detail and a problem-solving mindset to proactively mitigate study risks.
• Ability to interpret clinical protocols, regulatory guidance, and laboratory procedures.
• Ability to write clear, defensible monitoring findings and reports.
• Ability to adapt quickly and maintain rigorous quality standards in a fast-moving, mission-driven environment.
• Familiarity with biosample management and biobanking best practices.
• Proficiency in MS Word, Excel, and PowerPoint.

Nice To Haves

• Advanced degree such as an MS or MPH.
• Experience in oncology, molecular diagnostics, or precision medicine.
• Experience supporting CDx studies, including pharmaceutical co-development or bridging studies.
• Familiarity with EDC systems, CTMS, sample tracking platforms, and electronic records requirements (21 CFR Part 11).
• Clinical research certification such as ACRP-CP, CCRA, or CCRP.
• Prior experience in a regulated diagnostic or medical device environment.

Responsibilities

• 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 according to study-specific plans, including source data verification, essential document review, specimen tracking, and resolution of sample handling issues.
• Drive clinical study operations from start-up and site qualification through routine monitoring and close-out.
• Prepare objective monitoring visit reports and track site findings, protocol deviations, and CAPAs through resolution.
• Develop study-related documents and use sound judgment to advance work when standard processes are still being established.
• Collaborate with Clinical Operations, Regulatory Affairs, and Quality Assurance on study execution and quality expectations.
• Support IRB/EC submissions and ongoing ethical compliance.
• Prepare, review, file, and archive study documentation in the Trial Master File (TMF).
• Support audit readiness by preparing monitoring summaries and participating in internal audits or regulatory inspections.
• Identify, escalate, and resolve study risks, protocol deviations, and reportable events such as adverse events in accordance with regulations.
• Address problems beyond the immediate scope of the role when needed by the team or study.
• Work regularly with PHI and maintain current HIPAA, Human Subjects Protection, and GCP training.

Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.
• Free testing for employees and their immediate families.
• Fertility care benefits.
• Pregnancy and baby bonding leave.
• 401k benefits.
• Commuter benefits.
• Employee referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level