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Clinical Study Monitor
@Natera
[Hiring] Clinical Study Monitor @Natera
Apr 15, 2025 - Natera is hiring a remote Clinical Study Monitor. 💸 Salary: $98,400 - $123,000 usd. 📍Location: USA.
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Role Description
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.
- 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.
Requirements
- 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.
Benefits
- Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- 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.
- Generous employee referral program.
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
All others
All others
|
Salary
💸
$98,400 - $123,000 usd
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Apr 15, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
