Clinical Research Professional, Regulatory Affairs, UC Cancer Center

Clinical Research Professional, Regulatory Affairs, UC Cancer Center

Founded in 1819, the University of Cincinnati puts education into action, ranking 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, 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 $1.8 billion.

At UC, today's possibilities spark tomorrow's reality.

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 College of Medicine, Cancer Programs is looking for a Clinical Research Professional or Senior 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
The UCCC Start Up Coordinator will be responsible for overseeing a study from initial interest through opening to accrual at UC. Responsibilities include:

• 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.

Required Education

• 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.

Required Experience
1 year of relevant experience, preferably 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

• Office environment/no specific unusual physical or environmental demands.

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.

To apply, please go to https://bit.ly/3Qtub0Q

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.