Clinical Research Manager, UC Cancer Center

Current UC employees must apply internally via SuccessFactors 

 

Founded in 1819, the University of Cincinnati ranks among the nation’s best urban public research universities. Home to 53,235 students, more than 11,000 faculty and staff and 350,000+ living alumni, UC combines a Top 35 public research university with a physical setting The New York Times calls “the most ambitious campus design program in the country.”

 

With the launch of Next Lives Here, the Cincinnati Innovation District, a $100 million JobsOhio investment, three straight years of record enrollment, worldwide leadership in cooperative education, a dynamic academic health center and entry into the Big 12 Conference, UC’s momentum has never been stronger. UC’s annual budget stands at $1.85 billion, and its endowment totals nearly $1.8 billion.

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