Regulatory Affairs Manager

Jun 20, 2017
Institution Type
Four-Year Institution
About The Unit: The University of Chicago Medicine Comprehensive Cancer Center (UCCCC) is an integral component of the University of Chicago Medicine and the Biological Sciences Division (BSD), the largest of four Divisions of the University that also includes the Pritzker School of Medicine. The UCCCC administers 6 established scientific programs, and the Cancer Center Support Grant from the National Cancer Institute provides funding for 11 Shared Facilities. The Center comprises over 215 faculty members from over 20 departments, with members being awarded over $60 million Direct Costs in peer-reviewed cancer research grants, and $17 million in non-peer reviewed grants and contracts. The activities of the Center are broad and varied including research, patient education and support, fundraising, marketing, clinical trials management, community outreach, and grant administration. The UCCCC facilitates interactions between laboratory, clinical and population scientists to foster discovery and its translation into direct benefit to patients and the general public. The Cancer Center has an extremely active clinical trials research program with over 900 clinical trials, many of which are also conducted at UCCCC affiliate institutions (approximately 40). Community researchers also strive to eliminate health disparities among ethnic or social groups. The Regulatory Affairs Manager (RAM) will work in the Cancer Clinical Trials Office (CCTO), an existing centralized support office within the Cancer Center 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 CCTO is responsible for establishing standards, operating procedures, policies and practices, for coordinating system changes, implementing educational and training programs, developing communication tools, and managing the administrative functions that impact individuals involved in cancer clinical research.

Unit Job Summary: 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.

Unit Education: Bachelor's degree or a combination of education and related experience required (one year of education equals one year of experience). Bachelor's degree in a health related or relevant field preferred. Certification in clinical trials management preferred. Human subjects training preferred.

Unit Experience: A minimum of one year of regulatory compliance or directly related experience required. Two years of regulatory compliance or directly related experience preferred.

Unit Job Function Competencies: Good understanding of clinical trials management systems' main features, study management, patient management preferred. Solid knowledge and experience on Clinical Trials regulatory policies preferred. Experience in NCI, and other federal agencies, reporting policies preferred. Previous experience in implementing training programs preferred. Good computer, documentation, organization, and interpretational skills required. Excellent written and interpersonal skills required. Ability to effectively present oral and written information required. Analytical, problem solving, and decision making skills required. Attention to detail required. Ability to multitask required. Good interpersonal skills and ability to work independently and as part of a team required.

Similar jobs

Similar jobs