Clinical Research Coordinator

This position is located in Richmond VA (must be onsite 2-3 days a week)

Anticipated Start Date: Immediately

About the Company:

NIRSense is a medical technology company focused on developing world-leading wearable systems. Our tools measure blood 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 Clinical Research Coordinator to work alongside our growing scientific and clinical team in its Richmond, VA office. This person will coordinate with a wide range of physicians, patients, and company stakeholders as we explore our systems’ capabilities and grow the company towards a commercial launch. 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.

Salary: Compensation package will be commensurate with the successful applicant’s experience. Anticipated hiring range: $70,000-90,000.

Hours: Full time

Travel: Up to 25%

Minimum Qualifications:

• Undergraduate degree in Biomedical Engineering or the life sciences required
• Five years or more experience coordinating Clinical Research activities for medical technologies
• Experience writing and editing clinical protocols, scientific papers, and case studies
• Proficient in clear and succinct communication of scientific and research data
• Experience with literature searches and reference software
• Working 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 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
• Certification in Clinical Research coordination (CCRC, CCRP, or similar) a plus
• 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
• Lead the writing and editing of protocols, amendments, informed consents, study reports, monitoring plans, and other related clinical and regulatory documentation
• Train, remotely or 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 as needed
• Report to the Lead Scientist