Clinical Research Project Manager, Department of Neurology & Rehabilitation, Movement

Clinical Research Project Manager

The University of Cincinnati, College of Medicine, Department of Neurology and Rehabilitation Medicine is seeking a full-time Clinical Research Project Manager. The candidate will facilitate the coordination of a clinical trial repurposing sacubitril/valsartan for dementia. This is a single site clinical trial at the University of Cincinnati. The appropriate candidate will have extensive clinical trial coordination experience and regulatory experience, including investigational new drug (IND) studies with the Food and Drug Administration (FDA).

The project manager will work directly on coordination of study startup activities, regulatory oversight, and overseeing the site closure process. Salary is commensurate with the role.

Essential Functions:

• Work closely with the clinical research coordinators and data manager and share responsibilities for study management.
• Assist the trial investigators in broad oversight of all administrative aspects of the trial such as communication with the single Institutional Review Board, FDA, sponsor or other vendor.
• 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 investigators' meetings, contribute to the ongoing monitoring of recruitment and retention, and assist with other ongoing internal and external communication of collaborators.
• 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.
• Assist with trial cost tracking and manage resource allocation across vendors and operational teams.
• Ensuring IRB compliance throughout the study; reviewing site regulatory and staff documents; overseeing the delegation of authority log process; assisting with 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:

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

Required Trainings/

Certifications:

N/A.

Required Experience:

Five (5) years related experience. Additional Qualifications Considered:
Experience in an academic or clinical setting in the area of clinical specialization. SoCRA or ACRP certification.

Physical Requirements /Work Environment:
Sitting
- Continuously Hearing, listening
- Continuously Talking
- Continuously.

Compensation and Benefits: UC offers an exceptional benefits package designed to support your well-being, financial security, and work-life balance. Highlights include: salary/hourly pay rate information, comprehensive tuition remission, robust retirement plans, real work-life balance, and additional benefits including competitive salary based on experience, comprehensive health coverage, flexible spending accounts & wellness programs, professional development & mentorship opportunities.