Clinical Research Professional, UCCC Regulatory
Job description
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 47,000 students, 10,500 faculty and staff and 330,000 alumni, UC combines a Top 35 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, eight straight years of record enrollment, worldwide leadership in cooperative education, a dynamic academic health center and entry into the Big 12 athletic conference, UC’s momentum has never been stronger. UC’s annual budget tops $1.6 billion and its endowment totals $1.9 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.
Essential Functions
Regulatory
- 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.
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.
Required Trainings/Certifications
- For nursing focused role, BSN in the area of clinical specialization, and RN License in State of Ohio.
- For social work focused role, licensure in the area of clinical specialization.
Required Experience
- One (1) year of related experience.
- For nursing focused roles, appropriate clinical procedural experience.
Additional Qualifications Considered
Experience in an academic or clinical setting in the area of clinical specialization.
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.
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 / Minority / Female / Disability / Veteran.
REQ: 92468
SF:OMJ SF:RM SF:HEJ, SF:INS SF:HERC SF:DIV SF:LJN
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