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

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

Required Education

Required Experience

Five (5) years related experience.

Additional Qualifications Considered

Physical Requirements / Work Environment

Compensation and Benefits

UC offers an exceptional benefits package designed to support your well-being, financial security, and work-life balance. Highlights include :

Comprehensive Tuition Remission

UC provides tuition remission for you and your eligible dependents, covering tuition costs for nearly all undergraduate and graduate programs offered by the university.

Robust Retirement Plans

As a UC employee, you won't contribute to Social Security (except Medicare). Instead, you'll choose between state pension plans (OPERS, STRS) or an Alternative Retirement Plan (ARP), with UC contributing 1418% of your salary based on position.

Real Work-Life Balance

UC prioritizes work-life balance with a generous time-off policy, including :

Vacation and sick time

11 paid holidays and additional end-of-year paid time off (Winter Season Days)

6 weeks of paid parental leave for new parents

Additional Benefits Include :

To learn more about why UC is a great place to work, please visit our careers page at https : / / www.uc.edu / careers.html

UC is an E-Verify employer. If hired into this position, you will be required to provide satisfactory proof of employment eligibility by providing acceptable, original forms of identification for employment verification via the Federal I-9 employment verification process. A list of acceptable documents can be seen here : https : / / www.uscis.gov / i-9-central / form-i-9-acceptable-documents

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