Current UC employees must apply internally via SuccessFactors > http://bit.ly/UCEMPL
Founded in 1819, the University of Cincinnati embarks upon its third century - building on the past and defining the future by leading urban, public universities into a new era of innovation and impact through its strategic direction, Next Lives Here. Underscoring the power of creativity, ingenuity, invention and inclusion, what's Next will accelerate our unrivaled momentum, evidenced by eight straight years of record enrollment and rankings that include placement among America's top 100 public universities by U.S. News & World Report . Home to a diverse student body of nearly 47,000 and more than 4,200 distinguished faculty, the university combines its Research 1 (Very High Research Activity) Carnegie Classification with a physical setting that The New York Times recently acclaimed as "the most ambitious campus design program in the country".
As one of the oldest medical schools in the country, the University of Cincinnati College of Medicine (COM) 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. In partnership with the UC Health academic healthcare system and Cincinnati Children's Hospital Medical Center, College of Medicine's faculty are transforming the world of medicine every day.
The University of Cincinnati Cancer Center is looking to fill a regulatory position as either a Clinical Research Professional or Senior Clinical Research Professional. This position provides support and assistance for the University of Cincinnati Cancer Center. Duties focus on regulatory affairs. Essential Functions
Clinical Research Professional: 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
- Bachelor's Degree must be in a related field.
- Five (5) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.
- 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.
Additional Qualifications Considered
- One (1) year of related experience.
- For nursing focused roles, appropriate clinical procedural experience.
Physical Requirements/Work Environment
- Master's Degree
- Experience in an academic or clinical setting in the area of clinical specialization.
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
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.
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