Director of Regulatory Affairs
The University of Kansas Cancer Center
The University of Kansas Cancer Center is seeking an individual to serve 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.
· Direct daily administrative activities of the regulatory staff of 20-25 within the Clinical Trials Office, establish priorities, monitor work, assign and track tasks, responsible for direction of the staff in terms of selection, performance management and appraisals and discipline. Develop and recommend short and long-term program objectives and strategies for implementation. Develop and implement strategies to increase functionality within the regulatory unit of the Clinical Trials Office.
· Direct scope of work, objectives, quality of deliverables, and other project management activities of regulatory projects, which may be local or multi-regional in scope.
· Proactively track and monitor study specific trial management activities and systems. Direct the maintenance related to accurate study administration information (trial activity) and regulatory tracking systems in the Comprehensive Research Information System (CRIS). Direct and lead activities for regulatory coordinators related to their project-oriented tasks and disease working group assignments, to ensure that the regulatory program milestones are met as well as milestones related to the strategic plan on the KUCC are met. Responsible for ongoing individual and group training and development of staff, mentoring and coaching, and adherence to organizational policies and procedures.
· Promote a positive work environment that is maintained through open and effective communication. Oversee the regulatory compliance functions and continually review and ensure adequate resources are available to meet project deliverables and milestones. Identify project issues and suggests possible solutions; manage problem resolution through expedient and corrective means. Takes leadership role in the coordination of products and resources. Provide leadership through the continuous develop and implementation of improvement related to the regulatory program. Establish, direct and monitor regulatory group compliance of SOPs.
· Establish and ensure proper processes for compiling/collecting, distributing, and tracking regulatory documents and that all e-files, CRIS and/or hard-copy files are maintained. Ensure the effectiveness of the Regulatory Affairs Office of the KUCC by establishing and fostering strong relationships and efficient interactions with KU Cancer Center investigators, Clinical Program Management, study coordinators, the KUMC community and sponsors.
· Ensure quality of deliverables for projects of assigned investigators/clients. Participate in proposal and budget development, as needed Oversee regulatory/study administration education activities within the KUCC and other relevant university research groups to ensure that educational programs reflect current trends and regulatory guidelines, as well as, sound educational methods.
· Participate in and serve as senior member in Regulatory meetings, making reports and providing training as required. Participates on behalf of the Regulatory group in various site feasibility meetings with potential sponsors.
· Meet with the Clinical Trials Office Senior Executive Director on a weekly basis to provide updates. Provide monthly and yearly operational reports, as necessary, describing details of activity regarding studies and regulatory operations. Prepares written reports and memoranda as needed.
· Bachelor’s degree or higher in a scientific or healthcare related field. Master’s Degree in a scientific discipline preferred.
· 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.
KU Medical Center and the University of Kansas Cancer Center are Equal Opportunity/Affirmative Action employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disability status, or genetic information.
To apply, please go to: https://jobs.kumc.edu/
and reference Position number: J0083930.