CoMind
Healthcare
SeniorCRA
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior CRA at CoMind. Skills: Site monitoring, Clinical studies, Regulatory compliance. Conduct qualification monitoring visits. Conduct initiation monitoring visits”
Industry & Context.
Issue identification; Deviation identification; CAPA development
50% travel
What They're Looking For.
Must Have
Substantial clinical research experience, Extensive on-site and remote monitoring experience, Working knowledge of GCP, Working knowledge of ICH, Working knowledge of FDA, Working knowledge of applicable global clinical research regulations, Proven organisational skills, Proven documentation skills, Ability to manage multiple site relationships, Ability to manage multiple responsibilities simultaneously
Nice to Have
Background in medical devices, Experience with early feasibility studies, Experience with NSR studies, Experience with IDE-regulated frameworks, Familiarity with neurology, Familiarity with neurocritical care, Familiarity with TBI, Familiarity with ICU-based clinical settings, Experience coordinating IRB submissions, Experience managing regulatory documentation at sponsor level
What You'll Do.
Conduct qualification monitoring visits
Conduct initiation monitoring visits
Conduct interim monitoring visits
Conduct close-out monitoring visits
Perform source data review
Perform source data verification
Manage data query resolution
Evaluate site performance
Evaluate protocol adherence
Evaluate enrollment progress
Support CAPA development
Support inspection readiness
Support audit readiness
Build relationships with investigator sites
Maintain relationships with investigator sites
Provide training to sites
Provide guidance to sites
Provide support to sites
Ensure study continuity
Prepare IRB maintenance submissions
Submit IRB maintenance submissions
Track IRB maintenance submissions
Coordinate with central IRBs
Maintain Trial Master File quality
Support regulatory submissions
Support site activation activities
Manage IP accountability documentation
Embrace AI in daily work
Find new ways to use AI
How You'll Work.
Team & Collaboration
Partnership with clinicians; Cross-functional coordination
Process & Methodology
Trial management, IRB coordination
Full Job Description
This job is based remotely in the US, but you should be based in an Eastern or Central Time zone. 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, sup
Applying for this Senior CRA role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Ashby
- Ashby is a fast modern ATS — most applications take under 3 minutes.
- The resume parser is strong; verify parsed experience dates and job titles.
- Custom screening questions are often scored algorithmically — answer completely.
- Location field affects geo-based screening; use your actual metro area.
ANONYMOUS · UNFILTERED
What do employees actually say about CoMind?
Real rants from real employees. Read before you apply.