Clinical Research Project Manager

About the Role The Department of Neurology and Rehabilitation Medicine at the University of Cincinnati College of Medicine is seeking a full-time Clinical Research Project Manager to coordinate a single-site clinical trial repurposing sacubitril/valsartan for dementia. The role requires extensive clinical trial coordination and regulatory experience, including IND work with the FDA, and will oversee study startup, regulatory oversight, and site closure activities.

What You'll Do

• Coordinate study startup activities, regulatory oversight, and site closure for a single-site dementia trial.
• Work closely with clinical research coordinators and data manager to manage study operations.
• Assist investigators with administrative aspects, including IRB/FDA communications, training, and educational materials.
• Lead site readiness calls, plan investigators' meetings, monitor recruitment and retention, and manage communications with collaborators.
• Create the trial manual of procedures and coordinate safety monitoring with the data management center.
• Track trial costs and allocate resources across vendors and teams.
• Ensure IRB compliance; manage delegation of authority logs; assist with eConsent; facilitate changes to the PI and site regulatory documents; assist with the site regulatory and trial agreement processes.
• Oversee safety surveillance and CAPA processes; report adverse events and protocol deviations as required.

What We're Looking For

• Bachelor’s Degree.
• Nine (9) years of relevant work experience or equivalent training.
• Five (5) years of related experience.
• Experience in an academic or clinical setting in clinical specialization.
• SoCRA or ACRP certification.
• Extensive clinical trial coordination and regulatory experience, including IND studies with the FDA.

Nice to Have

• SoCRA or ACRP certification.

Compensation & Benefits

• Salary is commensurate with the role.
• UC offers an exceptional benefits package including Comprehensive Tuition Remission for employee and eligible dependents.