Apply on Employer Site

University of Cincinnati · 3 weeks ago

Clinical Research Project Manager, Department of Neurology & Rehabilitation, StrokeNet MINUTE trial

Cincinnati, OH

Full-time

Onsite

Senior Level

5+ years exp

The University of Cincinnati is a leading urban public research university committed to student success and community transformation. They are seeking a Clinical Research Project Manager to coordinate the NIH-funded MINUTE trial across 40 US sites, ensuring regulatory compliance and effective communication with performance sites.

AdviceConsultingFinancial ServicesTraining

Responsibilities

Work closely with NIH StrokeNet national leadership from the clinical and data management centers and share responsibilities for site management of the 40 StrokeNet performance sites

Assist the Trial Contact PI in broad oversight of all administrative aspects of the trial such as communication with the single Institutional Review Board and the NCC Contracts Team

Specific jobs will include assistance with the coordination and delivery of site protocol training for trial specific procedures, collaborate on the development of related educational materials, facilitate scheduling and leading site readiness calls, help with planning national investigators’ meetings, contribute to the ongoing monitoring of recruitment and retention, and assist with other ongoing communication with sites including newsletters and webinars

Share responsibility for creation of the trial manual of procedures and work with the data management center to implement the safety monitoring tasks of the study

Ensuring IRB compliance across all sites; reviewing site regulatory and staff documents; overseeing the delegation of authority log process; assisting with REDCap eConsent management; facilitating IRB approvals for site Principal Investigator changes; tracking and assisting with the clinical trial agreement process, including any modifications throughout the study; and participating in site readiness calls. Oversee safety surveillance throughout the study, including prompt reporting of unanticipated problems, non-compliance and/or serious protocol deviations to the single Institutional Review Board and Data Coordinating Center if applicable, and drive the Corrective Action and Preventive Action (CAPA) process

Perform related duties based on departmental need. This job description can be changed at any time

Qualification

Clinical trial coordinationRegulatory oversightSite managementSoCRA certificationACRP certificationCommunication skillsTeam collaborationProblem-solving skills