Senior CRA

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

We are seeking a Senior CRA to lead site monitoring activities, while also supporting a broad range of clinical responsibilities, including process development, in-house operations, and study oversight. This role is ideal for an experienced clinical research professional who excels in on-site and remote monitoring but is also capable of contributing to operational infrastructure, documentation, and trial management activities within the Clinical department. As CoMind’s first ever CRA, you will help shape the role’s direction, structure, and long-term impact.

Please note that this role will require approximately 40% travel, depending on study needs.

Responsibilities:

• Lead engaging on-site monitoring visits—from qualification through close-out—ensuring excellence in execution and full alignment with GCP/ICH, protocol, and SOPs.

• Dive into source data review/verification and drive swift, accurate query resolution to keep studies moving seamlessly.

• Continuously evaluate site performance, compliance, enrollment trends, and data quality to safeguard study success.

• Proactively spot issues, deviations, and risks, escalating and supporting effective CAPAs before they impact timelines.

• Build strong, collaborative site relationships, providing clear communication, guidance, and hands-on training.

• Craft, refine, and elevate SOPs, WIs, and operational tools that empower teams and strengthen quality.

• Identify operational gaps and champion process improvements that boost efficiency, consistency, and regulatory readiness.

• Oversee IRB submissions and maintain a high-quality TMF, ensuring all essential documents are accurate, timely, and inspection-ready.

• Support key operational activities—including feasibility, regulatory submissions, site activation, IP logistics, and study tracking—to keep studies on course.

• Contribute to study planning and risk management, playing an active role in inspection/audit readiness and overall operational excellence.

Skills & Experience:

• Extensive experience in clinical research preferably in medical devices

• Extensive on-site and remote monitoring experience

• Experience developing or supporting SOPs, WIs, and process documentation.

• Strong understanding of GCP, ICH, FDA, and global clinical research guidelines.

• Proficiency with EDC, eTMF, CTMS, and standard office software.

• Strong communication and relationship-building skills at both site and sponsor levels.

• Ability to prioritize effectively and manage multiple responsibilities.

• Excellent organizational and documentation skills with attention to detail.

Travel Requirement:

Approximately 40% travel depending on study needs.

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