What are the responsibilities and job description for the Senior Clinical Research Associate position at NIRSense Inc.?
Senior Clinical Research Associate
Location: Morrisville, NC
About the Company:
NIRSense is a medical technology company focused on developing world-leading wearable systems. Our tools measure oxygenation changes in the body 10x deeper than pulse oximetry and measure the electrophysiological activity of muscles and the brain. We are a small, dedicated team of technology developers seeking candidates interested in helping describe our capabilities to a wide range of interested stakeholders who are driven to transform the way humans understand and interact with their own health.
Job Summary:
NIRSense is seeking a Senior Clinical Research Associate to work alongside our growing research and clinical team in its Morrisville, NC office. This person will coordinate with a wide range of collaborators, including physicians, patients, and company stakeholders, as we advance our systems’ capabilities. The ideal candidate is an experienced professional looking to apply their skills toward clinical validation of NIRSense’s transformational capabilities. They work well in a fast-paced and high-performance team onsite in NC.
Travel: Up to 20%
Minimum Qualifications:
- Undergraduate degree in Biology, Clinical Research, Nursing, Biostatistics, or the life sciences required
- Three years or more experience with clinical research activities for medical technologies
- Experience with clinical study management tools such as RedCap
- Experience managing and preparing study documentation for IRB review
- Experience writing and editing clinical protocols, scientific papers, and case studies
- Proficient in clear and succinct communication of scientific and research data
- Experience with data acquisition and in performing basic data analysis on collected signals
- In-depth knowledge of medical concepts and terminology, particularly with experience describing medical devices, wearables, and/or optical systems
Preferred Qualifications:
- Graduate degree with a clinical focus preferred, including coursework in scientific writing and statistical analysis
- Experience with project management tools such as Microsoft Project, Monday.Com, ClickUp
- Experience coordinating clinical trials for human wearable medical devices
- Experience with physiological signals, including pulse oximetry, deep tissue oximetry, electrophysiological signals (ECG, EEG, EMG, etc.), or similar
- FDA-facing experience a plus, including clinical work and documentation toward 510(k) clearances and/or in de novo applications
- Prior experience working with small companies or startups
Roles & Responsibilities:
- Support NIRSense clinical strategy responsive to the company’s medical, military, and commercial goals
- Take on primary responsibility for clinical site liaising and management, ensuring compliance with Good Clinical Practices (GCP) and other applicable regulations
- Engage with internal and clinical teams to develop new clinical investigations, including clinical investigation plan (CIP) documentation, determine study endpoints and statistical power for clinical outputs, process cohort requirements per regulatory guidance, operate sensor systems in the clinical environment, and manage related study requirements
- Collect internal testing data from prototype devices to support development
- Lead the writing and editing of protocols, amendments, informed consents, study reports, monitoring plans, and other related clinical and regulatory documentation
- Prepare, clean, and analyze existing datasets for future scientific publications, reports, and presentations
- Prepare data upload, naming, and organizational protocols for new hardware development programs
- Train, on-site, study investigators, coordinators, and site personnel on system operation and troubleshooting
- Coordinate with institutional review boards (IRBs) to clearly explain the safety and efficacy of NIRSense products and clinical studies
- Perform study monitoring for compliance to protocols and to root cause testing issues
- Receive, upload, and aid processing of study data, including raw sensor outputs, processed data, clinical summaries, testing timelines, and related clinical reports
- Travel to clinical sites to foster clinician relationships and support study activities regularly
- Work closely with and report to the Dir. of Research on project deliverables
