Senior CRA

📋 Description

• • Be the founding Senior Clinical Research Associate (CRA) at CoMind, a venture-backed neurotechnology company that is redefining how clinicians monitor the human brain. You will sit at the intersection of cutting-edge hardware, regulatory science, and patient care, owning end-to-end site monitoring for first-in-human and pivotal studies that could change the trajectory of neurological diagnosis.
• • Own the full monitoring lifecycle—from pre-study qualification visits through close-out—ensuring every site operates at peak compliance with GCP, ICH, FDA 21 CFR Part 812, and internal SOPs. You will personally conduct on-site and remote visits, perform 100 % source-data verification, and drive real-time query resolution so that data integrity never becomes a bottleneck.
• • Act as the primary sponsor liaison for investigators, coordinators, and site management teams across the United States. You will deliver tailored training on protocol nuances, device handling, and eCRF completion, building trust that accelerates enrollment and reduces protocol deviations.
• • Continuously assess site performance through enrollment analytics, data-quality dashboards, and risk-based monitoring reports. When trends drift, you will craft corrective and preventive action plans (CAPAs) and shepherd them to rapid closure, protecting both timelines and patient safety.
• • Architect and refine clinical operations infrastructure. Because you are CoMind’s first CRA, you will co-author SOPs, work instructions, monitoring checklists, and CAPA templates that future team members will inherit. Your fingerprints will be on every process that scales our pipeline from one study to many.
• • Maintain an inspection-ready Trial Master File (TMF) in our eTMF system, ensuring every regulatory binder, CV, training log, and delegation log is contemporaneous and audit-proof. You will also shepherd IRB/EC submissions, amendments, and safety reports so that activation milestones are never delayed by paperwork.
• • Partner cross-functionally with Data Management, Regulatory Affairs, Quality Assurance, and Hardware Engineering to translate device specifications into feasible protocol designs, CRF structures, and data-validation rules. Your frontline feedback will directly influence next-generation sensor arrays and software algorithms.
• • Manage investigational product (IP) logistics, including temperature-controlled shipments, accountability logs, and reconciliation reports. You will coordinate with depots and sites to guarantee that every electrode set and calibration kit is where it needs to be, when it needs to be there.
• • Contribute to study-level strategy by drafting monitoring plans, risk-assessment matrices, and audit-readiness playbooks. During regulatory inspections, you will serve as a subject-matter expert, presenting source documentation and CAPA evidence with confidence and clarity.
• • Travel up to 40 % (primarily domestic, occasionally international) to academic medical centers and community hospitals, often on short notice, to rescue lagging sites or launch new ones. You will leverage remote-monitoring tools between visits to keep momentum high and costs low.
• • Champion a culture of continuous improvement. After every visit, you will debrief the Clinical Operations team, sharing best practices, lessons learned, and innovative tools that elevate the entire department. Your voice will shape how CoMind grows from a clinical-stage start-up into a global neurodiagnostics leader.