Position Summary: The Clinical Study Monitor oversees the day-to-day execution and monitoring of clinical studies involving in vitro diagnostic (IVD) devices, focusing on companion diagnostics (CDx) developed with pharmaceutical and academic partners. You will ensure studies meet protocol, company SOPs, and regulatory requirements (ICH-GCP, FDA, IVDR) while prioritizing data quality, subject safety, and inspection readiness.

At Natera, we remember there is a person behind every sample. We operate with urgency and scientific rigor to get meaningful products into the hands of clinicians and patients. This role works closely with Clinical Affairs leadership and cross-functional teams to drive study site compliance. You need a deep understanding of diagnostic lab operations and CDx studies, and the urgency to drive quality data without waiting for perfect structure.

Primary 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 based on the study-specific plan, including source data verification (SDV), essential document review, specimen tracking, and resolving sample handling issues.

Drive the operational execution of clinical studies, from start-up and site qualification through routine monitoring and close-out.

Prepare clear, objective monitoring visit reports, tracking site findings, protocol deviations, and CAPAs through to resolution.

Take ownership of developing study-related documents, relying on strong judgment to move work forward even when standard processes are still being built.

Collaborate across Clinical Operations, Regulatory Affairs, and Quality Assurance to align on study execution and quality expectations.

Support IRB/EC submission activities and ensure ongoing ethical compliance.

Manage study documentation, including preparation, review, filing, and archiving 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 (e.g., adverse events) in accordance with regulations.

Step in and solve problems outside your immediate scope when the team or the study needs it.

Work regularly with PHI, maintaining current status on all HIPAA, Human Subjects Protection, and GCP training requirements.

Qualifications:

BA/BS degree in life sciences, nursing, or a related field (advanced degree such as MS or MPH is a plus).

Minimum of 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.

Nice to Have:

Experience in oncology, molecular diagnostics, or precision medicine.

Experience supporting CDx studies, including pharmaceutical co-development or bridging studies.

Familiarity with electronic data capture (EDC) systems, CTMS, sample tracking platforms, and electronic records requirements (21 CFR Part 11).

Certification in clinical research (e.g., ACRP-CP, CCRA, CCRP).

Prior experience in a regulated diagnostic or medical device environment.

Knowledge, Skills, and Abilities:

Strong project management skills with the ability to coordinate and execute multiple studies.

Clear, direct communication that builds 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 complex clinical protocols, regulatory guidance, and laboratory procedures.

Capable of writing clear, defensible monitoring findings and reports.

Able to adapt quickly and maintain rigorous quality standards in a fast-moving, mission-driven environment where patient outcomes are the priority.