Clinical Research Professional, College of Medicine

Location
Ohio, United States
Posted
02 Jun 2019
End of advertisement period
02 Aug 2019
Ref
37703
Contract Type
Permanent
Hours
Full Time

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 Institute. Duties focus on regulatory affairs.

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

Minimum Qualifications:  Bachelor’s degree in related discipline or equivalent education/experience; 1 year of directly relevant experience, preferably in an academic, clinical, or laboratory setting.

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 / M / F / Veteran / Disabled.