Job Description
Senior Clinical Research Professional, UC Cancer Center, Regulatory
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 over 50,000 students, 11,000 faculty and staff and 332,000 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, global 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.
Job Overview
UC is one of the largest employers in the Cincinnati region, employing over 15,000 full time and part time faculty, staff and student workers. The College of Medicine, Cancer Programs is looking for a Clinical Research Professional. This position will support the University's mission and commitment to excellence and diversity in our students, faculty, staff and all our activities.
This position provides support and assistance for the University of Cincinnati Cancer Center. Duties focus on regulatory affairs.
The UC Clinical Research Professional: Regulatory Affairs, Start up Coordinator will be responsible for overseeing a study from initial interest through opening to accrual at UC.
Essential Functions
Work to support feasibility and scientific review processes
Completing initial IRB submission
Assist in preparation of site adapted ICF according to local requirements
Collecting and completing essential regulatory documentation for start-up
Coordinating contract and budget submissions
Providing ongoing status reports about studies in start-up process
Interacting daily with sponsors, CROs, and internal UC staff
Related, other duties as assigned
Minimum Requirements
Bachelor's degree in related discipline or equivalent education/experience; 1-3 years of relevant experience, ideally in an academic, clinical, or laboratory setting.
Additional Qualifications Considered
Knowledge of medical and pharmaceutical terminology and concepts, as well as theoretical knowledge and/or bachelor's degree and/or equivalent education and/or experience in a field related to biological sciences as needed to work in Regulatory Affairs.
Excellent communication skills with sponsors, coworkers, and physicians.
Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
Experience preparing various forms, documents, and reports, such as Investigational Drug Fact Sheet, New Study Applications, Renewal Applications, IND Applications, etc.
Experience preparing, reviewing, and understanding clinical research protocols, and protocol amendments.
Experience developing and maintaining record management systems. Strong administrative and organization skills, experience prioritizing assignments when faced with a heavy workload and competing deadlines.
Experience creating Informed Consent Documents that comply with HRPP/UC IRB policies and procedures, FDA regulations, and sponsor requirements.
Experience using standard word processing and data management software programs, including Word and Excel, in order to develop and prepare reports.
Experience with editing, including summarizing information into concise and condense documents.
Proven ability to determine sources of information and data and to analyze the data and information obtained, in order to create documents and to propose solutions to issues. Detail oriented, logical, and methodological approach to problem solving.
Demonstrated knowledge or demonstrated related experiences to comprehend, interpret, and apply regulations and legislation regarding the protection of human subjects. These include regulations under federal policies, FDA, and other compliance agencies or directive.
Working knowledge of UC Human Research Protections Program (HRPP/IRB) policies and Procedures.
Physical Requirements/Work Environment
Sitting - Continuously
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 .
For questions about the UC recruiting process or to request accommodations with the application, please contact Human Resources at .
The University of Cincinnati is an Equal Opportunity Employer.
REQ:95359
SF:OMJ SF:RM SF:HEJ, SF:INS SF:HERC SF:DIV SF:LJN SF:IHE
Senior Clinical Research Professional, UC Cancer Center, Regulatory
Date:
Feb 20, 2024
Location:
Cincinnati, OH, US
Facility:
Main Campus
Nearest Major Market: Cincinnati
Job Segment:
Compliance, Regulatory Affairs, Medical Research, Clinical Research, Pharmaceutical, Legal, Healthcare, Science
The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / Minority / Female / Disability / Veteran.
