Clinical Research Manager, UC Cancer Center
Current UC employees must apply internally via SuccessFactors > http://bit.ly/UCEMPL
Founded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to more than 50,000 students, 11,000 faculty and staff and 340,000 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, nine 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 tops $1.65 billion and its endowment totals $1.8 billion. The University's overall regional economic impact exceeds $10.6 billion, paving the way for the future of Cincinnati.
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. This position will support staff and clinical trials focused in malignant hematology.
Essential Functions
- Guide and direct 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.
- Provide support, direction and coaching to staff during the hiring process, training, disciplinary action, problem resolution, planning, and work assignment delegation.
- Provide 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.
- Oversee adherence and provide guidance related to all relevant internal/external SOPs, policies, and workflows, Good Clinical Practice, and FDA regulations.
- Ensure that accrual data and each subject data is entered into the Clinical Trial Management System (CTMS).
- Assist CTO leadership in developing strategic planning goals and initiatives for clinical research.
- Liaise and work 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.
- Interact daily with the CTO Regulatory Manager, CTO Data and Quality Assurance Manager, and CTO Assistant Director to ensure all protocol requirements are met.
- Work 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.
- 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
Compensation and Benefits
UC offers a wide array of complementary and affordable benefit options, to meet the financial, educational, health, and wellness needs of you and your family. Eligibility varies by position and FTE.
- Competitive salary range dependent on the candidate's experience.
- Comprehensive insurance plans including medical, dental, vision, and prescription coverage.
- Flexible spending accounts and an award-winning employee wellness program, plus an employee assistance program.
- Financial security via our life and long-term disability insurance, accident and illness insurance, and retirement savings plans.
- Generous paid time off work options including vacation, sick leave, annual holidays, and winter season days in addition to paid parental leave.
- Tuition remission is available for employees and their eligible dependents.
- Enjoy discounts for on and off-campus activities and services.
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).
To learn more about why UC is a great place to work, please visit our careers page at https://www.uc.edu/careers.html.
For questions about the UC recruiting process or to request accommodations with the application, please contact Human Resources at jobs@uc.edu.
The University of Cincinnati is an Equal Opportunity Employer.
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