Asks for

The ad says“Identify and escalate site issues, deviations, and risks; support CAPA development and inspection and audit readiness activities”
The ad says“Identify and escalate site issues, deviations, and risks; support CAPA development and inspection and audit readiness activities”
The ad says“Strong working knowledge of GCP, ICH, FDA, and applicable global clinical research regulations”
The ad says“Proficiency with EDC, eTMF, CTMS, and standard office software”
The ad says“Perform source data review and verification, manage data query resolution, and evaluate site performance, protocol adherence, and enrollment progress”
The ad says“Proficiency with EDC, eTMF, CTMS, and standard office software”
The ad says“Proficiency with EDC, eTMF, CTMS, and standard office software”
The ad says“Strong working knowledge of GCP, ICH, FDA, and applicable global clinical research regulations”
The ad says“Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in accordance with GCP, ICH, the study protocol, and CoMind SOPs”
The ad says“Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in accordance with GCP, ICH, the study protocol, and CoMind SOPs”
The ad says“Maintain Trial Master File quality, support regulatory submissions and site activation activities, and manage IP logistics and accountability documentation”
The ad says“Prepare, submit, and track IRB maintenance submissions including continuing reviews, amendments, and safety updates, coordinating directly with central IRBs to ensure timely approvals”
The ad says“Extensive on-site and remote monitoring experience as a sponsor-side CRA”
The ad says“Proficiency with EDC, eTMF, CTMS, and standard office software”
The ad says“Maintain Trial Master File quality, support regulatory submissions and site activation activities, and manage IP logistics and accountability documentation”
The ad says“Perform source data review and verification, manage data query resolution, and evaluate site performance, protocol adherence, and enrollment progress”
The ad says“Maintain Trial Master File quality, support regulatory submissions and site activation activities, and manage IP logistics and accountability documentation”

This job is based remotely in the US, and is expected to work East Coast hours. CoMind can only accept applications residing in the current states: Colorado, Florida, Missouri, Texas, Washington State, Wisconsin.

At CoMind, we are developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring. In joining us, you will be helping to create cutting-edge technologies that will improve how we diagnose and treat brain disorders, ultimately improving and saving the lives of patients across the world.

The Role

The Clinical Team leads the deployment of CoMind's technology into hospital environments for the first time, managing clinical sites, supporting device installations, and ensuring the smooth execution of clinical studies in partnership with clinicians.

As Senior CRA, you will own site monitoring across CoMind's clinical programme, with responsibility spanning on-site and remote visits, in-house operations support, and study oversight. This is a hands-on role with real breadth: you will be the primary relationship owner at investigator sites while also contributing to trial management and IRB coordination internally.

Please note that this role will require approximately 50% travel, depending on study needs.

Responsibilities:

Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in accordance with GCP, ICH, the study protocol, and CoMind 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 and audit readiness activities
Build and maintain strong relationships with investigator sites, providing training, guidance, and support to ensure study quality and continuity
Prepare, submit, and track IRB maintenance submissions including continuing reviews, amendments, and safety updates, coordinating directly with central IRBs to ensure timely approvals
Maintain Trial Master File quality, support regulatory submissions and site activation activities, and manage IP logistics and accountability documentation
AI is fundamental to our culture -- it's not just a tool, but a core part of how we work, collaborate, and innovate. We expect all team members to embrace AI in their daily work and continuously find new ways to use it effectively.

Skills & Experience:

Substantial clinical research experience, with a 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 organisational and documentation skills, with the ability to manage multiple site relationships and responsibilities 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 a sponsor level.

Benefits:

Company equity plan
Annual Unlimited PTO
Health insurance plan - CoMind contributes 50% to the monthly premium (with the Blue Cross Network)
Dental insurance (50% Employer Contributions to individual policy)
Vision insurance (50% Employer Contributions to individual policy)
401k plan with an employer match up to 3%
Mental health resources

Asks for

Values