Clinical Research Professional - Department of Obstetrics and Gynecology

Company: University of Cincinnati
Location: Cincinnati
Posted on: January 15, 2021

Job Description:

Current UC employees must apply internally via SuccessFactors > http://bit.ly/UCEMPLUC 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, Department of Obstetrics and Gynecology is looking for a Clinical Research Professional. Duties focus on regulatory affairs. This position will support the University's mission and commitment to excellence and diversity in our students, faculty, staff and all our activities.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 and procedures and Good Clinical Practice guidelines for the conduct of clinical research.* Prepare and submit research documents and reports, such as FDA Forms 1572, start-up regulatory packets, initial IRB submissions, safety letters, Serious Adverse Events (SAEs), protocol amendments and annual continuing reviews. * Assist in preparation of FDA audits, internal audits and monitoring visits.* Prepare and maintain study regulatory binders to include all IRB approved study documents, correspondence and other required documentation. This includes maintaining study training, Delegation of Authority logs and study certificates for research staff.* Experience developing and maintaining record management systems. Strong administrative and organization skills, experience prioritizing assignments when faced with a heavy workload and competing deadlines.* Draft Informed Consent Documents that comply with 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.* Maintain knowledge of UC Human Research Protections Program (HRPP/IRB) policies and procedures and Central IRB policies and procedures. * Related other duties, as assignedMinimum Requirements:Bachelor's degree in related discipline, or equivalent, preferred.One-year related experience, preferably in an academic or clinical seng.For nursing-focused role, current/valid RN license to pracce in the State of Ohio required,, appropriate clinical procedural experience required.Preferred Qualifications:For nursing-focused role, CR cerficaon preferred.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: 57821SF:LJN (OMJ) SF:RM SF:HEJ SF:INS SF:HERC SF:DIV

Keywords: University of Cincinnati, Cincinnati , Clinical Research Professional - Department of Obstetrics and Gynecology, Other , Cincinnati, Ohio