The University of Kansas Cancer Center is seeking a Director of Quality Assurance for the Clinical Trials Office (CTO) to be responsible for managing a quality assurance system and team that promotes customer satisfaction in accordance with the KUCC strategic plan related to all phases of clinical and translational research for internal investigators, the Midwest Cancer Alliance (MCA), Children’s Mercy Hospital, (CMH) and in collaboration with outside clients. Champion continuous improvement efforts and ensure all clinical trials office effort is completed in accordance with SOPs, policies, practices and state and federal guidelines.
- Provide leadership for research operations and conduct research studies in accordance with FDA guidelines, GCP and SOPs. Primary areas of responsibilities focus on auditing, monitoring, quality assurance, process improvement, staff education and training.
- Initiate and implement quality improvement activities as appropriate to raise the performance of the CTO, including establishing and implementing metrics for monitoring process effectiveness. Provide monthly and yearly operational reports, as necessary, describing details of activity regarding quality assurance operations. Prepare written reports and memoranda as needed.
- Establish, direct and monitor Clinical Trials Office compliance of SOPs. Provide monthly and yearly operational reports, as necessary, describing details of activity regarding quality assurance operations. Prepare written reports and memoranda as needed.
- As assigned by CTO Executive Director, serve as main point of contact on behalf of CTO during external audits and serve as the CTO team lead to develop correction action plans, as needed. Identify project issues and suggest possible solutions; manage problem resolution through expedient and corrective means.
- Responsible for ongoing individual and group training and development of staff, mentoring and coaching, and adherence to organizational policies and procedures. Use monitoring and audit findings as retraining tool in order to clarify processes, best practices, GCPs and protocol compliance.
- Work with CTO Team Managers to identify educational needs and develop educational plans. Identify learning needs for re-education and conduct training on these topics as needed. Work with CTO Team Managers to oversee planning and implementation of new staff orientation. Serve as mentor. Perform and/or oversee new employee quality data checks and communicate findings to management.
- Assist study team with study planning/preparation/management of IIT studies as needed.
- Direct the daily administrative activities of the Quality Assurance unit 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. Oversee the Quality Assurance functions and continually review and ensure adequate resources are available to meet project deliverables and milestones.
- Bachelor's and/or Nursing degree.
- 7 or more years of clinical research management experience in an academic setting, pharmaceutical company environment or in a regulatory agency.
- Minimum of 5 years of management level experience.
- Extensive knowledge of FDA regulations relevant to drugs, devices, biologics. Previous experience hosting and responding to FDA inspections. Previous working knowledge and experience with the FDA and Pharmaceutical sponsors.
- Attention to detail with excellent analytical and problem-solving skills. Thorough knowledge and understanding of medical, laboratory, and clinical trial concepts and terminology.
- Ability to manage multiple tasks, set priorities and meet deadlines. Engaged team member 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 applications. Minimal travel to attend national meetings.
- Master’s degree Advanced certifications in the areas of quality assurance preferred.
KU Medical Center is an Equal Opportunity/Affirmative Action employer. 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: M0204696