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

About the role

The University of Cincinnati College of Medicine, Department of Neurology and Rehabilitation Medicine is seeking a full-time Clinical Research Project Manager. The ideal candidate will have extensive clinical trial coordination experience and regulatory experience, including IND studies with the FDA.

Responsibilities

• Work closely with the clinical research coordinators and data manager and share responsibilities for study management.
• Aid 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.
• Create the trial manual of procedures and work with the data management center to implement the safety monitoring tasks of the study.
• Manage trial cost tracking and resource allocation across vendors and operational teams.
• Ensure IRB compliance throughout the study; review site regulatory and staff documents; oversee the delegation of authority log process; assist with 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; and 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, and drive the Corrective Action and Preventive Action (CAPA) process.

Qualifications

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

Benefits

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

• Comprehensive Tuition Remission
• Roth 403(b) Retirement Plan
• Flexible Spending Accounts & Wellness Programs
• Professional Development & Mentorship Opportunities

Pay

Salary is commensurate with the role.

Schedule

Full-time position.

Skills

Extensive clinical trial coordination experience and regulatory experience, including IND studies with the FDA.

Benefits

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

• Comprehensive Tuition Remission
• Roth 403(b) Retirement Plan
• Flexible Spending Accounts & Wellness Programs
• Professional Development & Mentorship Opportunities

Benefits

To learn more about why UC is a great place to work, please visit our Careers Page. 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. Click here for a list of acceptable documents.