New · posted Nov 7
Natera · Medical Devices
Clinical Study Monitor
- Remote, US
- Remote
- Full-time
- Senior & Principal
The role
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.
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 management.
What you need
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.
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.
Familiarity with biosample management and biobanking best practices.
Proficiency in MS Word, Excel, and PowerPoint.
Nice to Havenice 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.
What you'll do
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.
Pay
$108,200 – $140,000 a year
Employer providedCompetitive 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!
For more information, visit www.natera.com.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page
Working conditions
Physical Demands & Work Environment
Duties are performed in a hybrid or office setting requiring computer use, video conferencing, and occasional work during non-standard hours to meet deadlines or coordinate with external partners.
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
$108,200—$140,000 USD
Equal opportunity, accessibility and legal noticesNatera's statements, word for word
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
Job intelligence
The context around this role
Live data · November 7, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Clinical Research roles at this level.
This roleEmployer provided
Senior & Principal roles in the US60 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $108,200 | — | $140,000 |
| All US (middle half) | $108,500 | $124,500 | $124,750 |
This role: Natera's own published range. Comparisons: the base pay employers published on open Clinical Research roles at the same level on Regulatory Jobs, November 7, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Research
The general path across 229 open Clinical Research roles on Regulatory Jobs, with the titles they carry most. Not Natera's own promotion track.
Career resources on Clinical Research
Skills DNA
What this role leans on
How many of the posting's 35 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct11
- GMP and compliance10
- Lab testing and methods9
- Documentation and SOPs8
- Collaboration and leadership8
- Regulatory submissions4
- Investigations and CAPA3
- Data and digital systems3
- Validation and qualification1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Research work in medical devices, led by the six this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devicesNamed in the posting
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigationsNamed in the posting
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signaturesNamed in the posting
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health informationNamed in the posting
- EUEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices RegulationNamed in the posting
- ISOISO 14155(official source, opens in a new tab)Good clinical practice for clinical investigations of medical devices
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
From Regulatory News
Company hiring pulse
Natera on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 3
- Locations
By discipline
- Quality2 40%
- Clinical2 40%
- Regulatory1 20%
By level
- Senior & Principal2 40%
- Director1 20%
- Manager1 20%
More roles at Natera
- View role
Associate Director, Clinical Science
Remote, USDirectorMedical Devices$172K
- View role
Commission, Qualification and Validation (CQV) Engineer II
Austin, TXAssociate & SpecialistBiotechnologySalary not listed
- View role
Manager QC Development
San Carlos, CAManagerBiotechnology$140K
- View role
Senior Regulatory Affairs Specialist
Remote, USSenior & PrincipalMedical Devices$83K
Similar Clinical Research roles elsewhere
- View role
Clinical Site Lead
AbbottRemote, US) - Indianapolis, Cincinnati, Columbus territoriesSenior & PrincipalMedical Devices$61K–$123K
- View role
Senior Clinical Site Lead
AbbottRemote, US) - Cleveland, OH / Buffalo, NY territorySenior & PrincipalMedical Devices$78K–$156K
- View role
Clinical Site Lead
AbbottRemote, US) - Houston, TX territorySenior & PrincipalMedical Devices$61K–$123K
- View role
Sr. Field Clinical Research Specialist
MedtronicRemote, USSenior & PrincipalMedical Devices$129K–$170K
Clinical Study Monitor at Natera
Open until filled. $108K–$140K a year, employer provided.