This position serves as the Director of the Regulatory Affairs Office of the Clinical Trials Office (CTO), providing regulatory expertise regarding all phases of clinical and translational research for both internal investigators, the Midwest Cancer Alliance (MCA) and in collaboration with outside clients. This position is responsible for the continued development of the regulatory office, its services and products in accordance with the KUCC strategic plan. As required, this position will also participate in project-related work. This position will direct and supervise functional service and collaborative projects ensuring the clients satisfaction, ensuring client relationship management and quality deliverables related to the regulatory program. This position is responsible for ensuring that all work is completed in accordance with SOPs, policies, practices and state and federal guidelines. This position is located at the Clinical Research Center in Fairway, Kansas.
Bachelor’s degree or higher in a scientific or healthcare related field. 5 or more years clinical research experience. Minimum of 3 years of management level experience. Previous working knowledge and experience with the FDA and Pharmaceutical sponsors Demonstrated leadership and administrative skills to properly manage project operations. Attention to detail with excellent analytical and problem-solving skills. Ability to work effectively under periodic stressful conditions. Thorough knowledge and understanding of medical, laboratory, and clinical trial concepts and terminology. Ability to manage multiple tasks and set priorities and meet deadlines. Work within a team approach and be motivated to work consistently in a fast-paced, “customer-focused” environment. Excellent organizational, managerial and communication skills. Ability to motivate staff with respect for team members. Computer literate including Microsoft Word, Excel and Access applications. Familiarity with management database systems utilizing tables, queries, etc. Minimal travel to attend national meetings, etc.
Master’s Degree in a scientific discipline. 7 or more years of research project management experience in an academic setting, pharmaceutical company environment or in a regulatory agency. 5 or more years management level experience. Extensive knowledge of regulations relevant to drugs, devices, or biologicals in the US.
Internal Number: J0083930
About University of Kansas Cancer Center
The University of Kansas Cancer Center (KUCC), through world-class research, partnerships and patient care, is working toward a world without cancer. Every day, KU Cancer Center doctors and scientists collaborate on new and more effective drug and treatment therapies to prevent, treat and, ultimately, end cancer.
The University of Kansas Cancer Center is the region's only National Cancer Institute-designated cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research. The University of Kansas Cancer Center is a world-class, community-based cancer research and care partnership spanning two states and involving collaboration among researchers, physicians and cancer support professionals. Our partnerships include cancer research and healthcare professionals associated with the University of Kansas Medical Center, the University of Kansas Health System, the University of Kansas in Lawrence, the Stowers Institute for Medical Research, Children’s Mercy Hospital and the members of the Midwest Cancer Alliance.