Senior Clinical Research Scientist (On-Site)

Job Description

Job DescriptionSalary:

Title: Senior Clinical Research Scientist

Location: Morrisville, NC (On-site)

Travel: Up to 10%

Reports To: Director of Research

About the Company

NIRSense is a cardiology company focused on developing world-leading noninvasive medical systems. Our tools measure oxygenation changes in the body 10x deeper than typical pulse oximetry and track the electrophysiological activity of muscles and the brain. We are a small, dedicated team of technology developers seeking candidates interested in helping advance our capabilities for a wide range of interested stakeholders who are driven to transform the way humans understand and interact with their own health.

Position Summary:

We are seeking a Senior Clinical Research Scientist to support the design, management, and analysis of human research studies focused on wearable medical devices. This role combines expertise in biostatistics, bioinformatics, data analysis, and clinical study operations to advance our device validation efforts. The ideal candidate will have experience coordinating clinical trials, preparing regulatory submissions, and performing in-depth analysis of physiological data. This is a fully on-site position based in Morrisville, NC, working closely with engineers, scientists, clinicians, and external research collaborators to generate high-quality data and impactful insights that support product development and regulatory approval.

Key Responsibilities:

• Design, coordinate, and manage human subject research studies involving wearable medical devices.
• Prepare IRB applications and maintain compliance with regulatory bodies (GCP, FDA, etc.).
• Analyze study data using advanced statistical methods including linear mixed-effects modeling and longitudinal data analysis.
• Collaborate with the Director of Research and cross-functional teams on clinical investigation plans, protocol development, and endpoint design.
• Write, edit, and review scientific and regulatory documents including protocols, informed consent forms, and study reports.
• Support internal and external teams with data interpretation, visualization, and statistical communication.
• Oversee data acquisition workflows, ensuring signal integrity and alignment with study goals.
• Engage with clinicians, researchers, and study coordinators to train on devices, troubleshoot study issues, and collect high-quality data.
• Contribute to FDA submissions and other regulatory documentation.
• Prepare datasets for publications and work with collaborators on conference and journal submissions.
  
  

Minimum Qualifications:

• Masters degree in Biostatistics, Bioinformatics, Biology, or related life sciences field.
• 3+ years of experience in clinical research, study coordination, or biostatistics within a medical device or academic research setting.
• Experience managing IRB submissions and clinical trial documentation.
• Strong background in statistical analysis of human research data (R, SAS, or Python preferred).
• Proficient in tools such as RedCap, Google Colab, Jupyter, and data visualization platforms.
• Experience analyzing physiological signals (e.g., EEG, EMG, pulse oximetry) or biomedical time series data.
• Experience in small companies or fast-paced startup environments.
• Excellent written and verbal communication skills for cross-disciplinary collaboration.
  
  

Preferred Qualifications:

• PhD in Biostatistics, Bioinformatics, or Clinical Research.
• Experience with clinical research tools and project management platforms (e.g., ClickUp, Monday.com).
• Experience with optical, electrophysiological, or wearable medical devices.
• FDA-facing experience a plus, including clinical work and documentation toward 510(k) clearances and/or in de novo applications.