Located in the University of Washington School of Medicine Office of Research and Graduate Education (RGE) with essential responsibilities in the Institute for Translational Health Sciences (ITHS), the Director will establish and lead a joint CTO to sustain and strengthen clinical research at the University of Washington. RGE and ITHS house complementary resources with an outstanding opportunity to unify and synergize services to clinical researchers.
UW Medicine is the home of biomedical research at the University of Washington, with nearly 1,900 active clinical trials and clinical studies. UW is the largest publicly funded research university in the United States and second in the nation in total federal research grants and contracts. We are ranked second in the world for the impact of our clinical medicine and pharmacy research. Eight healthcare entities comprise UW Medicine including the School of Medicine (SOM), four hospitals and medical centers, a regional network of primary care clinics, a physician practice group and Airlift Northwest.
RGE promotes and facilitates responsible research, teaching and training. RGE builds and enhances infrastructure, provides UW Medicine and University leadership with strategic information and analysis, fosters an open and collaborative environment, streamlines processes, and maximizes opportunities for achievement in research.
ITHS is a $70M health research institute based at the University of Washington, with integrated partnerships with Seattle Children’s and Fred Hutchinson Cancer Research Center, and more than 20 other organizations engaged in health research in five states in the Pacific Northwest region. The mission of ITHS is to accelerate the translation of scientific discoveries to the clinic to improve the health of people in our region and beyond.
The Clinical Trials Office (CTO) Director is a new position requiring strong navigational abilities to work successfully with numerous stakeholders, an understanding of researchers’ needs and responsibilities, and knowledge of the full range of both investigators’ and institutional clinical research regulations and compliance requirements. The Director develops goals and action plans in partnership with the Vice Dean and the Director of the Office of Research and Graduate Education, the ITHS Principal Investigator and ITHS Executive Director. This position actively collaborates with research leaders across UW Medicine, Fred Hutch, Seattle Cancer Care Alliance (SCCA) and Seattle Children's, serving as UW's lead operational role in integrating clinical research support infrastructure.
The ability to think strategically about programmatic and financial solutions is critical for this position, as are advanced skills in organizational design and management of teams. The CTO Director leads a matrixed set of functions and teams spanning the RGE and ITHS service operations, whose leadership work together regularly and closely. Installation of a tri-institutional Clinical Trials Management System software solution and continuing growth in clinical facilities requires consistent attention to integration needs.
The CTO Director is the senior administrator responsible for developing and overseeing services to all clinical research at the University of Washington, including nearly 1,900 active clinical studies each year utilizing UW Medicine's and Seattle Cancer Care Alliance's medical facilities and physician services. The Director brings together historically separate service areas and staff to achieve systematic support and new efficiencies for grants and the academic departments which administer them. Resources in the CTO are housed in both SOM's Office of Research and Graduate Education and the Institute for Translational Health Sciences. The position has direct impact on policy making, research and Medicare compliance, training and education, administrative and financial planning for clinical scientists across all Health Sciences schools, and partner institutions in the Puget Sound and Pacific Northwest region.
Leadership and Planning
Under the direction of the Directors of RGE and ITHS, and working closely with the Vice Dean and Associate Dean, oversee operations of the Clinical Trials Office (CTO) and all subsidiary functions and teams. Provide leadership, support and guidance to CTO units, assure alignment with institutional priorities and regulatory requirements.
Direct core services supporting the full life cycle of clinical trials, including the development of protocols, IRB assistance, budget negotiations, study start-up, participant recruitment and on-study support, research billing, FDA submissions and audit support.
Develop strong, collaborative working relationships intra- and inter-institutionally to ensure shared standards, unified approaches, and ample and effective communication among stakeholders and across research partner institutions.
Develop and implement strategic plans, policies and processes for business development and growth of clinical trials.
Develop and implement process improvements and initiatives to enhance the overall effectiveness of the CTO. Engage stakeholders, capitalize on opportunities, identify high-level barriers to program success and propose solutions.
Serve as a knowledgeable resource about the clinical trial process and procedures at the University of Washington and provide education resources for study staff and investigators.
Manage data systems, metrics and reporting. Work closely with ITHS Evaluation Program to ensure the collection and reliability of key data for grant submissions and program evaluation.
Maintain knowledge of current and emerging best practices and regulatory changes. Represent the CTO with institutional administrators, inter-institutional leadership and collaborative groups, and national research networks. Write reports and communications, present at meetings, and communicate effectively.
Assure strong performance and service orientation across all units through resource allocation, team development, clear objectives and timelines, analysis, and the use of project management tools and methodologies.
Provide proactive financial management, including planning, analysis and reporting. Ensure cost center performance. Provide forecasts and identify resources required.
Recruit, direct and manage CTO staff. Assure compliance with University HR policies, build organizational capacity and oversee professional development.
Lead the planning and completion of projects to achieve priority goals and objectives.
Establish and sustain a culture of collaboration within and beyond CTO operations.
Represent CTO in meetings with investigators, study coordinators, academic department directors, and other customers.
Implement marketing and communication plans to promote services, gain feedback, and improve customer service.
Manage scope and priorities to meet key deliverables.
Other duties as assigned.
Master’s degree in Business Administration, Health Care Administration or related field; plus 4-5 years of relevant experience. Equivalent experience can substitute for degree requirement.
Strong background in Good Clinical Practice (GCP) implementation and training.
Skill to plan, direct, and manage within a complex organizational structure.
Experience in clinical trials management and policy.
Strong analytical skills to solve complex problems and situations.
Demonstrated skill to independently develop business, fiscal, and project plans.
Ability to communicate effectively with a variety of constituencies.
Skill to collaborate and succeed in a consensus environment.
Demonstrated skill to build, lead, and serve on outstanding teams.
Ability to manage demanding workflow and competing deadlines.
Skill to efficiently learn.
Skilled development of reports, graphs, charts, and other visuals as required.
Proficiency in MS Word, Access, Excel, and PowerPoint.
RN or Masters in scientific or educational field.
Experience in academic health sciences area.
Experience developing policy and regulatory guidance.
The University of Washington (UW) is proud to be one of the nation’s premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research and community service. Our staff not only enjoys outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement, artistic pursuits, and natural beauty.