The University of Cincinnati Cancer Institute (UCCI) Clinical Trials Office is an institutional resource within the College of Medicine and UC Health that provides administrative, nursing, and data management support for cancer clinical trials conducted by UC Investigators. The Clinical Research Manager oversees the implementation of clinical trials in the Clinical Trials Office (CTO).  The selected candidate will provide expert level knowledge in clinical trial practices and regulations and ensures compliance. Working under the direct supervision of the UCCI CTO Administrative Director and CTO Medical Director as well as Principal Investigators to ensure safe implementation of oncology clinical trials, the Clinical Research Manager has duties that include but are not limited to:

• Guides and directs a team of clinical research nurses and coordinators assigned to the various disease teams within the Clinical Trials Office.
• Provides support, direction and coaching to clinical research coordinators in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation.
• Provides daily management/supervision to the clinical research coordinators to promote maximum enrollment, safe participation and exemplary conduct, and generation of accurate and complete data of the clinical research activities within the Clinical Trials Office.
• Oversees adherence to SOPs, Good Clinical Practice, and FDA regulations.
• Ensures that accrual data and each subject data is entered into the Clinical Trial Management System (CTMS).
• Assists CTO leadership in developing strategic planning goals and initiatives for clinical research.
• Liaises and works efficiently in collaboration with the CTO Associate Director of Operations and with other departments at the University to ensure adequate financial accounting regarding clinical research projects, including budget development and reconciliation.
• Interacts on a daily basis with the CTO Regulatory Manager, CTO Data and Quality Assurance Manager, CTO Associate Director of Operations to ensure all protocol requirements are met.
• Works with study sponsors, IRB, and other regulatory offices as needed.

Minimum Qualifications:

• Bachelor’s degree, preferably in a health-related or scientific field
• 5 - 10 years of directly related clinical research experience, preferably in an academic or clinical setting

Preferred Qualifications:

• Knowledge of clinical research, human subjects research ethics, and IRB procedures
• Thorough understanding of Good Clinical Practice guidelines, Code of Federal Regulations, clinical trials monitoring, regulatory compliance. Strong qualitative skills and knowledge of study design.
• Knowledge of medical terminology as well as the policies and regulations relevant to oncology clinical trials
• Ability to build, lead, motivate, and assess a professional team
• Excellent verbal and written communication skills in daily interactions with the ability to interpret and apply University of Cincinnati, UC Health policies and federal, state, and local regulations
• Ability to manage multiple priorities, organize, and prioritize work to meet deadlines.
• Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies
• Knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook)

The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.

As a UC employee, and an employee of an Ohio public institution, if hired you will not contribute to the federal Social Security system, other than contributions to Medicare. Instead, UC employees have the option to contribute to a state retirement plan (OPERS, STRS) or an alternative retirement plan (ARP).

The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / M / F / Veteran / Disabled.