Clinical Research Regulatory and Operations Coordinator Inv

$65,000 - $120,744/Yr

Nuvance Health - Danbury, CT

Full-time

Danbury, CT

Nursing and Residential Care Facilities

About the position

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.

Responsibilities

• Collect, review and submit all documents required for initiating IIR.
• Coordinate study start-up documentation requests in an organized package and submit to the IRB.
• Compile documents, including CVs, licenses, certificates, training logs, and financial disclosures for all study staff involved in IIR.
• Ensure all documentation for active studies remains current and file appropriately.
• Support the daily operations of IIR by providing efficient administrative services, including maintaining IIR databases and study tracking spreadsheets.
• Handle invoicing, billing, and tracking payments and revenue for internal and external stakeholders.
• Attend onsite study initiation meetings with study teams.
• Prepare regulatory documents, safety reports, and serious adverse event submissions.
• Participate in internal and external regulatory quality assurance reviews and audits.
• Serve as a research coordinator for departmental IIR research projects as required.

Requirements

• Master's level education required.
• Clinical Research Coordinator certification preferred.
• 2 years experience in Clinical Research preferred.