Senior Regulatory Affairs and Research Systems Manager - Pediatrics

Department

BSD PED - Clinical Trials Office

About the Department

In the Department of Pediatrics at the University of Chicago, we strive to provide the highest level of complex care for children from diagnosis and treatment to conducting research to find promising new therapies with a focus on teaching. We are committed to advancing the frontiers of knowledge, and the education and training of future clinical pediatricians, subspecialists, educators, clinical investigators and physician-scientists. The Department of Pediatrics is a dynamic, stimulating place to work, and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles.      

The Pediatric Clinical Trials Office (Peds CTO) is an existing centralized support office that provides services and high-level guidance to individuals (faculty, investigators, research staff, and clinic coordinators from the University and Hospital) involved in human subjects research. The Peds CTO is responsible for establishing standards, operating procedures, policies and practices, implementing educational and training programs, developing communication tools, and managing the administrative functions that impact individuals involved in clinical research.   

Job Summary

The Senior Regulatory Affairs and Research Systems Manager functions as a leader in the Department’s dynamic clinical research program by managing regulatory and compliance functions for studies conducted in the Department of Pediatrics, overseeing Clinical Trial Management System functionality, and provide expertise in research study conduct. The Senior Regulatory Affairs and Research Systems Manager will have specialized knowledge of regulatory requirements for conducting human subjects research across local and central IRBs; will be responsible for management and oversight of regulatory processes for all Pediatric clinical research programs and projects; and will mentor, guide, and train staff using technical systems. The research projects involve multi-centered cooperative group studies, single-site studies, inter-group studies, grant application and funded studies, industry studies, and investigator-initiated studies. The Senior Regulatory Affairs and Research Systems Manager will be expected to participate in established and future research programs and will serve as the main contact for regulatory purposes requiring interaction with principal investigators, co-investigators, affiliate institutions, sponsoring agents, the Food and Drug Administration (FDA), the Institutional Review Board (IRB), and other regulatory bodies. This role will also be responsible for developing and implementing quality improvement initiatives within the Pediatric Clinical Trials Office. This role will also be the primary liaison with the Divisional Office of Clinical Research for Pediatric representation with Clinical Trial Management Systems.

Responsibilities

• Oversee Departmental Clinical Research Portfolio across the lifecycle for each protocol from feasibility, startup, recruitment, day-to-day conduct, follow up through study close out, including Institutional Review Board (IRB) submission and approval, specialty subcommittee reviews, as well as FDA, IND, and IDE submissions and maintenance. 

• Participates in planning, development, coordination, and implementation of studies that promote and enhance research collaboration with individuals/groups internal and external to the organization. 

• Serves as a liaison between principal investigators (PI), co-investigators, sponsoring agents, regulatory bodies, and other members of the research team, leading study teams in meeting internal and external regulatory compliance requirements and serving a vital role during study start-up, monitoring, and audits. 

• Partner with PI and study team regarding strategic planning around clinical research portfolios. Establish professional relationships with Contract Research Organizations, Pharmaceutical Sponsors, Funders and Grantors. 

• Uses specialized expertise to manage compliance documentation submission and maintenance, compliance training, compliance committee formation, and other programmatic functions. 

• Advises the development of a formalized training program for both