Reporting to study leadership, this role provides study-wide project management and serves as the primary regulatory lead for the Tufts single IRB, coordinating across clinical operations, data management, laboratory operations, investigative project teams, documentation, training, and stakeholder communications. Serve as primary regulatory lead for the Tufts single IRB of record: prepare and maintain submissions, modifications, continuing reviews, reportable new information, consent revisions, reliance agreements, and the study regulatory binder; advise investigators and site staff on compliance strategy across sites.