Clinical Research Project Manager, Department of Neurology & Rehabilitation, StrokeNet CLARITY Trial

Clinical Research Project Manager, Department of Neurology & Rehabilitation, StrokeNet CLARITY Trial

The University of Cincinnati, College of Medicine, Department of Neurology and Rehabilitation Medicine is seeking a full-time Clinical Research Project Manager. As the StrokeNet National Clinical Coordinating Center (NCC) Project Manager of this NIH-funded study, the candidate will facilitate the coordination of CLARITY (Cilostazol for Prevention of Recurrent Stroke) multicenter trial. There will be 100 US sites. The appropriate candidate will have extensive clinical trial coordination experience. The project manager will work directly with performance sites in the clinical trial, including the coordination of site startup activities, regulatory oversight, and overseeing the site closure process. The appropriate candidate will have extensive clinical trial / large observational study coordination and regulatory experience. Salary is commensurate with the role.

Essential Functions

• Work closely with NIH StrokeNet national leadership from the clinical and data management centers and share responsibilities for site management of the 100 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.

Required Education

Required Experience

Five (5) years related experience.

Additional Qualifications Considered

Physical Requirements / Work Environment