CoMind

• Design, build, and configure clinical study databases (EDC, CTMS, eTMF), including eCRF design and annotation, database design specifications, and data validation (edit check) specifications. • Execute and document user acceptance testing (UAT) of clinical databases, including edit check testing, and manage database amendments and version control across the study lifecycle. • Develop and maintain SOPs governing data entry screen design, edit check testing, validation approval, and database configuration workflows. • Serve as the primary point of contact for site users on EDC and eCRF issues, providing troubleshooting, guidance, and escalation support throughout study conduct; provide equivalent support for eTMF access and issues. • Manage user account provisioning, role-based access, and timely deprovisioning across the EDC/CDMS and eTMF, maintaining access logs and audit trails in accordance with 21 CFR Part 11 access-control requirements. • Develop and maintain data management plans, CRF completion guidelines, data review plans, and protocol deviation specifications, ensuring data quality and integrity from source through to submission. • Conduct ongoing data review for quality issues and data trends; generate and manage queries, perform discrepancy management, and drive query resolution to clean files. • Generate and review data listings, summaries, and reports to support ongoing data review by the DSML team and clinical study reports. • Define data transfer specifications for external data sources (e.g., device, imaging) and perform reconciliation of external data with the clinical database, including SAE reconciliation. • Execute database lock activities, including final data review, clean file declaration, and lock documentation in support of regulatory submissions. • Serve as the organization's subject matter expert on regulatory expectations for clinical trial data, ensuring compliance with GCP (ICH E6(R3)), CDISC standards, 21 CFR Part 11, 21 CFR Part 812, ISO 14155, and applicable FDA guidance; maintain inspection-ready documentation in the eTMF and support internal audits and FDA inspections. • Manage data management vendor and CRO relationships, including review of proposals, budgets, and scopes of work, and ongoing tracking of deliverables, metrics, and timelines. • Contribute to the evaluation, validation, and continuous improvement of data management software tools and systems. • Partner closely with the Data Science & Machine Learning (DSML) team to ensure clinical data assets are structured and maintained to support regulatory submissions, clinical decision-making, and advanced analytics; provide input to protocols and other clinical study documents, and serve as data management liaison across DSML, Quality, Regulatory, and Medical Affairs. • 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.

Role 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 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. - 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. Qualifications - 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 Requirements - Experience with early feasibility studies, NSR studies, or IDE-regulated frameworks (nice to have) - Familiarity with neurology, neurocritical care, TBI, or ICU-based clinical settings (nice to have) - Experience coordinating IRB submissions and managing regulatory documentation at a sponsor level (nice to have) 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

• Develop and maintain clinical project plans, timelines, and budgets; lead site feasibility assessments, selection, and CTA negotiations for assigned studies • Prepare and review key study documents including protocols, ICFs, CRFs, and study manuals in accordance with ISO 14155, FDA/ICH guidelines, and CoMind SOPs • Oversee site initiation, monitoring, and close-out visits, ensuring protocol adherence and data quality; track enrollment and KPIs and proactively mitigate risks to study timelines • Review monitoring reports and drive timely resolution of site issues, deviations, and CAPA activities • Manage clinical data activities including CRF completion, query resolution, and data cleaning in collaboration with data management • Ensure study conduct compliance with 21 CFR Parts 812, 50/56, ISO 14155, and GCP; support internal and external audits and FDA inspections as required • Author and review clinical study reports, periodic safety reports, and clinical evaluation reports; provide regular study status updates to senior management and cross-functional stakeholders • 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.