comind - Senior CRA
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT
Requirements
• 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 • 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.
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. • Proficiency with EDC, eTMF, CTMS, and standard office software
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
No credit card. Takes 10 seconds.