Regulatory Affairs Manager

Department BSD MED – Administration – CRSO About the Department The mission of the Clinical Research Support Office (CRSO) is to promote and facilitate the conduct of clinical research in the Department of Medicine. The Department of Medicine has a long tradition of conducting original and rigorous biomedical and clinical research of fundamental significance. The CRSO assists in the expansion of this remarkable research program by providing centralized support services for our faculty. These services include protocol development, study planning, research staff planning, compliance consultation, and outsourced regulatory support in the form of IRB and FDA submission and ongoing management. Job Summary Regulatory Affairs Managers function as essential members of our dynamic clinical research teams by managing regulatory functions for studies conducted in the Department of Medicine. These clinical research studies may involve various areas of medicine and modalities of treatment. Research projects include investigator authored studies, as well as industry sponsored research. Responsibilities Regulatory Affairs Managers handle all regulatory functions for a large portfolio of studies. This includes Institutional Review Board (IRB) approval, all specialty subcommittee reviews, and FDA IND and IDE submission. Regulatory Affairs Managers serve as liaisons between principle investigator, co-investigators, sponsoring agents, regulatory agencies, and other members of the research team. Regulatory Affairs Managers lead PI’s and study teams in meeting internal and external regulatory compliance requirements, and serve a vital role during study audits. Partner with PI study team to maximize clinical research efficiency and progress. Consult with PI team regarding strategic planning around clinical research portfolios. Participate in protocol writing. Facilitate study initiation through thoughtful and timely preparation of IRB, sub-committee and FDA submissions. Prepare and maintain all materials related to IRB and FDA approvals. Ensure successful monitoring and auditing of studies including FDA, sponsor and/or internal study audits. Present research portfolio progress during research team meetings. Provide guidance to faculty regarding compliance, funding and research support resources. Maintain a high level of self-education to include review of articles related to clinical research; attend multi-disciplinary conferences; attend workshops specific to clinical research. Assist in the orientation and training of new and current Clinical Research Support Office staff and/or staff in the various sections of the Department of Medicine. Plans and executes internal and external audits and activities to support regulatory agency inspections. Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings. Performs other related work as needed. Minimum Qualifications Education: Minimum requirements include a college or university degree in related field. Work Experience: Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline. Certifications: (none specified) Preferred Qualifications Experience: Project management. Regulatory compliance. Clinical research and/or data management. Experience at a large academic or medical institution. Technical Skills or Knowledge: Proficiency with Microsoft Word and Excel. Proficiency with Adobe Acrobat. Preferred Competencies: Outstanding project management. Excellent verbal and written communication skills. Ability to manage stressful situations. Analytical thinking and problem-solving. Attention to detail. Strong organizational skills. Strong Interpersonal skills. Work independently with a high degree of initiative. Work as part of a team. Ability to maintain confidentiality. Job Details Job Family: Legal & Regulatory Affairs Role Impact: Individual Contributor FLSA Status: Exempt Pay Frequency: Monthly Scheduled Weekly Hours: 37.5 Benefits Eligible: Yes Drug Test Required: No Health Screen Required: No Motor Vehicle Record Inquiry Required: No Posting Statement The University of Chicago is an affirmative action/equal opportunity/disabled/veterans organization and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University’s Notice of Nondiscrimination. Staff Job seekers in need of a reasonable accommodation to complete the application process should call View phone number on click.appcast.io or submit a request via Applicant Inquiry Form. We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange. All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position. #J-18808-Ljbffr