Clinical Research Manager, Department of Surgery, Division of Transplantation

Job Overview

As one of the oldest medical schools in the country, the University of Cincinnati College of Medicine (COM) has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients. In partnership with the UC Health academic healthcare system, the College of Medicine’s doctors and faculty are transforming the world of medicine every day. The Department of Surgery is a top-tier department with world-renowned faculty and staff. With world-class research, teaching and medical practice opportunities, why not choose the University of Cincinnati College of Medicine?

The University of Cincinnati College of Medicine, Department of Surgery, Section of Transplant Surgery is seeking a Clinical Research Manager to plan, organize, and execute multiple interdisciplinary clinical research programs. Duties are primarily focused within one or more areas of the clinical research spectrum.

Essential Functions

• Oversee the implementation of clinical research studies, including adherence to SOPs, Good Clinical Practice, and FDA regulations as applicable. Work on contracts. Assist leadership in developing strategic planning goals and initiatives for clinical research. Contribute to protocol design and logistics. Work with study sponsors, IRB, and other regulatory offices for timely submission of relevant documents.
• Interact on a daily basis with the research team and principal investigator to ensure all protocol requirements are met.
• Liaise and work efficiently in collaboration with the other research and business personnel in the Department to ensure adequate financial accounting regarding clinical research projects, including invoice submission, budget development, and fiscal reconciliation.
• Provide daily management/supervision to the clinical research staff to promote maximum enrollment, safe participation and exemplary conduct, and generation of accurate and complete data of the clinical research activities.
• Serve as an informational and referral resource for the research community.
• Continually evaluate research processes for compliance and efficiency within the department and the university and contribute ideas for improvement.
• Mitigate risk through working with physicians/faculty, business analysts, legal and the Office of Clinical Research. Work with necessary parties to identify compliance, legal, IP and business/financial risk.
• Provide direct and/or indirect supervision to exempt and non-exempt research staff (i.e., hiring/firing, performance evaluations, disciplinary action, approve time off, etc.).
• Perform related research duties based on departmental need. This job description may be modified based on Department need.

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 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.
• Masters in Clinical Research.
• IRB and Regulatory submission experience.

Physical Requirements/Work Environment