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

University of Cincinnati • Cincinnati, OH

89d

About The Position

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 the Minimally Invasive Neuro-endoscopic Ultra-Early Targeted ICH Evacuation (MINUTE) multicenter trial. There will be 40 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.

Requirements

• Bachelor’s Degree.
• Nine (9) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.
• Five (5) years related experience.

Nice To Haves

• Experience in an academic or clinical setting in the area of clinical specialization.
• SoCRA or ACRP certification.

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.
• Assist 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.
• Assist with other ongoing communication with sites including newsletters and webinars.
• Share responsibility for creation of the trial manual of procedures.
• Work with the data management center to implement the safety monitoring tasks of the study.
• Ensure IRB compliance across all sites; review site regulatory and staff documents.
• Oversee the delegation of authority log process.
• Assist with REDCap eConsent management.
• Facilitate IRB approvals for site Principal Investigator changes.
• Track and assist with the clinical trial agreement process, including any modifications throughout the study.
• Participate 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.
• Drive the Corrective Action and Preventive Action (CAPA) process.
• Perform related duties based on departmental need.

Benefits

• Comprehensive Tuition Remission for you and your eligible dependents.
• Robust Retirement Plans with UC contributing 14–18% of your salary based on position.
• Generous time-off policy including vacation and sick time, 11 paid holidays, and additional end-of-year paid time off.
• 6 weeks of paid parental leave for new parents.
• Competitive salary based on experience.
• Comprehensive health coverage (medical, dental, vision, prescription).
• Flexible spending accounts & wellness programs.
• Professional development & mentorship opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree