Job Overview

As one of the oldest medical schools in the country, the UC College of Medicine 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.

The University of Cincinnati Cancer Center (UCCC) Clinical Trials Office is an institutional resource within the University of Cincinnati 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). S/he provides expert level knowledge in clinical trial practices and regulations and ensures compliance. The incumbent will work under the direct supervision of the UCCC CTO Administrative Director and CTO Medical Director as well as Principal Investigators to ensure safe implementation of oncology clinical trials.

Essential Functions

• Guide and directs a team of clinical research coordinators, clinical research assistants, and office-based coordinators assigned to the disease team(s) of oversight within the Clinical Trials Office.
• Provides support, direction and coaching to staff during the hiring process, training, disciplinary action, problem resolution, planning, and work assignment delegation.
• Provides daily management/supervision to the clinical research team 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 and provides guidance related to all relevant internal/external SOPs, policies, and workflows, 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 Assistant Director and with other departments at the University to ensure adequate financial accounting regarding clinical research projects, including budget development and reconciliation.
• Interacts daily with the CTO Regulatory Manager, CTO Data and Quality Assurance Manager, CTO 
• Assistant Director to ensure all protocol requirements are met.
• Works with study sponsors, IRB, and other regulatory offices as needed.
• Provide coverage as part of the research team as needed, including research participant visits and study-related data, in order to maintain compliance and/or meet deadlines.

Minimum Requirements

• Bachelor’s degree, ideally in a health-related or scientific field.
• Nine (9) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.
• Minimum of 5 years of clinical research experience.
• 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).

Additional Qualifications Considered

• Master’s degree with at least 3 years of supervisory experience.
• Nursing Degree and experience with management of oncology trials.
• Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRP) certification.

Physical Requirements/Work Environment