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CoMind is developing non-invasive neuromonitoring technology to advance clinical brain monitoring and improve diagnosis and treatment of brain disorders.
As Senior Clinical Research Associate (CRA), you will lead site monitoring across CoMind's clinical program, serving as the primary relationship owner at investigator sites while managing both on-site and remote monitoring activities. This is a hands-on role with significant breadth of responsibility spanning clinical trial execution, regulatory coordination, and operational support.
Key Responsibilities:
- Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in accordance with GCP, ICH, study protocol, and company SOPs
- Perform source data review and verification, manage data query resolution, and evaluate site performance, protocol adherence, and enrollment progress
- Identify and escalate site issues, deviations, and risks; support CAPA development and inspection/audit readiness
- Build and maintain strong relationships with investigator sites, providing training, guidance, and support
- Prepare, submit, and track IRB maintenance submissions including continuing reviews, amendments, and safety updates; coordinate with central IRBs
- Maintain Trial Master File quality, support regulatory submissions and site activation, manage IP logistics and accountability documentation
- Embrace AI as a core tool for collaboration and innovation in daily work
Note: This role requires approximately 50% travel depending on study needs and is based remotely in the US with expectation to work East Coast hours. CoMind can only accept applications from residents of Colorado, Florida, Missouri, Texas, Washington State, and Wisconsin.
Requirements:
- Substantial clinical research experience with background in medical devices preferred
- Extensive on-site and remote monitoring experience as a sponsor-side CRA
- Strong working knowledge of GCP, ICH, FDA, and applicable global clinical research regulations
- Proven organizational and documentation skills with ability to manage multiple site relationships simultaneously
- Proficiency with EDC, eTMF, CTMS, and standard office software
Nice to Have:
- Experience with early feasibility studies, NSR studies, or IDE-regulated frameworks
- Familiarity with neurology, neurocritical care, TBI, or ICU-based clinical settings
- Experience coordinating IRB submissions and managing regulatory documentation at sponsor level
