Nuvance Health - Danbury, CT
posted 3 months ago
The Clinical Research Regulatory and Operations Coordinator is a full-time position based in Danbury, CT, responsible for overseeing the regulatory and operational aspects of investigator-initiated research (IIR) studies. This role reports directly to the VP of Research and Innovation and involves close collaboration with research leadership, staff, and investigators to ensure the smooth execution of IIR studies across various therapeutic departments, excluding the Cancer Center. The coordinator will manage all regulatory submissions, including those to the Institutional Review Board (IRB), and will be involved in billing, invoicing, and tracking of research activities. The coordinator will collect, review, and submit all necessary documents for initiating IIR studies, ensuring that all study staff documentation, such as CVs, licenses, and training logs, is current and properly filed. Daily operations support includes maintaining IIR databases, study tracking spreadsheets, and generating departmental minutes and agendas. The coordinator will also handle invoicing and billing, ensuring timely submission of paperwork for continuing reviews to the IRB. In addition to these responsibilities, the coordinator may serve as a research coordinator for departmental IIR research projects as needed, preparing regulatory documents, safety reports, and participating in internal and external regulatory quality assurance reviews and audits. The position requires a master's level education and a preference for candidates with Clinical Research Coordinator certification and at least two years of experience in clinical research.