The Regulatory Affairs Manager (RAM) will have specialized detailed knowledge of regulatory requirements for conducting human subjects research; will be responsible for management and oversight of regulatory processes for specialized clinical research programs and projects; and will actively participate as a member of the research team in coordination, implementation and conduct of these studies. The research projects may involve multi-centered cooperative group studies, single site studies, inter-group studies, industry studies, and investigator initiated studies that are synchronized in the Cancer Center and implemented in Departments and Sections conducting cancer research. The RAM will be expected to participate in established and future research programs and will serve as liaison requiring interaction with principal investigators, co-investigators, internal review committees, affiliate institutions, sponsoring agents, the National Cancer Institute (NCI), the Food and Drug Administration (FDA), the Institutional Review Board (IRB), and other regulatory bodies. The RAM will ensure the highest level of quality by keeping abreast of new guidelines, regulatory changes, policies and procedures to ensure that all guidelines (governmental as well as institutional) are met on a consistent basis. The RAM will play a central role in implementing a training program for clinical research staff. The responsibilities will include refining existing training modules and developing new training for clinical research staff across departments, and working with departmental management staff to monitor compliance and the effectiveness of the training.Specific tasks include:- Regulatory Management: With respect to each research project, the work to be accomplished will be delineated by the processes and procedures defined by the University of Chicago's IRB and other regulatory agencies including the FDA, as well as study sponsor requirements.- Industrial, Institutional and Federal Interface: Liaison between the Principal Investigator and external sponsor and funding source representatives to provide required regulatory documents and coordinate responses to the Institutional Review Committee (IRB) and external agencies (including NCI and the FDA).- Education: The RAM will refine existing training procedures and develop additional training for the clinical research staff across departments.- Quality Assurance/Quality Control: The RAM will implement quality control procedures for review and preparation of accurate regulatory documents for submission to the Institutional Review Board (IRB), the Clinical Trials Review Committee (CTRC), NCI, FDA, and other external sponsors.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or status as an individual with disability.The University of Chicago is an Affirmative Action / Equal Opportunity / Disabled / Veterans Employer.Job seekers in need of a reasonable accommodation to complete the application process may contact Human Resources by calling 773-834-1841 or by emailing firstname.lastname@example.org with their request.
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