Job Overview
Location
Remote, US
Job Type
Full-time
Category
DevOps
Date Posted
June 4, 2026
Full Job Description
đź“‹ Description
- • Lead the planning, execution, and oversight of clinical studies for CoMind’s non-invasive neuromonitoring technology, ensuring timely delivery, budget adherence, and regulatory compliance.
- • Develop and maintain detailed clinical project plans, timelines, and budgets, including site feasibility assessments, selection, and CTA negotiations for assigned studies.
- • Prepare and review critical study documents such as protocols, informed consent forms (ICFs), case report forms (CRFs), and study manuals in alignment with ISO 14155, FDA/ICH guidelines, and CoMind SOPs.
- • Oversee site initiation, monitoring, and close-out visits to ensure protocol adherence, data integrity, and timely resolution of site-level issues and deviations.
- • Track patient enrollment and key performance indicators (KPIs), proactively identifying and mitigating risks that could impact study timelines or outcomes.
- • Manage clinical data activities including CRF completion, query resolution, and data cleaning in close collaboration with the data management team.
- • Ensure full compliance with 21 CFR Parts 812, 50/56, ISO 14155, and Good Clinical Practice (GCP) standards throughout all phases of clinical trials.
- • Support internal and external audits and FDA inspections by preparing documentation and coordinating responses as required.
- • Author and review clinical study reports, periodic safety reports, and clinical evaluation reports to support regulatory submissions and post-market activities.
- • Provide regular, clear status updates on study progress to senior management and cross-functional stakeholders including regulatory, data science, and clinical operations teams.
- • Manage relationships with clinical sites and/or CROs, ensuring effective communication, performance, and alignment with study objectives.
- • Contribute to the integration of AI into daily workflows, leveraging AI tools to enhance efficiency, accuracy, and innovation in clinical project management.
- • Travel approximately 20% of the time to clinical sites and meetings, as required by study needs and operational demands.
- • Collaborate cross-functionally across departments to align clinical strategy with regulatory, technical, and business goals.
- • Maintain accurate and up-to-date electronic trial master files (eTMF) and clinical trial management systems (CTMS).
- • Ensure all clinical activities are conducted with the highest standards of patient safety and ethical conduct.
🎯 Requirements
- • 3-6 years of clinical research experience, with at least 2 years in medical device clinical trials
- • Demonstrated knowledge of FDA regulations (21 CFR 812), ISO 14155, and GCP guidelines
- • Hands-on experience managing clinical sites and/or CRO relationships
- • Proficiency with EDC, eTMF, CTMS, and standard office software
- • Strong communication, organizational, and documentation skills with the ability to manage multiple studies simultaneously
🏖️ Benefits
- • Company equity plan
- • Annual Unlimited PTO
- • Health insurance plan with CoMind contributing 50% to the monthly premium (Blue Cross Network)
- • Dental insurance with 50% employer contribution to individual policy
- • Vision insurance with 50% employer contribution to individual policy
- • 401k plan with employer match up to 3%
- • Mental health resources
Skills & Technologies
GCP
Remote
About CoMind Technologies Inc.
CoMind Technologies is focused on redefining how the brain is measured and treated. They are developing non-invasive neurotechnology with the goal of optimizing patient outcomes across the care continuum. Their technology aims to provide doctors with access to a wide array of critical neurophysiological signals through a single, simple bedside measurement. CoMind Technologies is working to improve patient outcomes through photonics technology. The company recently announced $102.5 million in funding to further its mission of redefining clinical monitoring of the brain.
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