- The UCCC Start up Coordinator will be responsible for overseeing a study from initial interest through opening to accrual at UC.
- Work to support feasibility and scientific review processes.
- Complete initial IRB submission.
- Assist in preparation of site adapted ICF according to local requirements.
- Collect and complete essential regulatory documentation for start-up.
- Coordinate contract and budget submissions.
- Provide ongoing status reports about studies in start-up process.
- Interact daily with sponsors, CROs, and internal UC staff.
- Related, other duties as assigned.
- Bachelor's degree in related discipline or equivalent education/experience.
- 1-3 years of relevant experience, ideally in an academic, clinical, or laboratory setting.
- 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.
- Experience in an academic or clinical setting in the area of clinical specialization.
- 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.
- Sitting - Continuously
- 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.
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Clinical Research Professional, Regulatory Affairs, Start Up Coordinator - Cincinnati, United States - University of Cincinnati
Description
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 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.
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.
This position will support the University's mission and commitment to excellence 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
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.
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 atFor 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.
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Clinical Research Professional, Regulatory Affairs, Start Up Coordinator
Date:
May 7, 2024
Location:
Cincinnati, OH, US
Facility:
Main Campus
