Senior Trial Start-Up Analyst - Clinical Trials Office

**Job Description*****This recruitment offers a $8,000 recruitment incentive to eligible new employees***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 enjoy outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement, artistic pursuits, and natural beauty.UW Medicine works to improve the health of the public by advancing medical knowledge, providing outstanding primary and specialty medical care to people of the region, and preparing tomorrow’s physicians, scientists, and other health professionals. Within the large UW Medicine health system, the School of Medicine (SoM) is a world leader in biomedical research, with the largest biomedical research program at a public university based on National Institutes of Health funding and ranking among the top research universities internationally.The Clinical Trials Office (CTO) supports the clinical research mission of UW Medicine. The CTO is an operational unit within the SoM’s Office of Research and Graduate Education charged with providing multi-service support to clinical researchers bringing important new therapies to our patients in compliance with evolving regulatory requirements.**Position Summary**The Clinical Trials Office has an outstanding opportunity for a Senior Trial Start-up Analyst (Analyst). Reporting to the Trial Start-up and Special Projects Manager (Manager), this role will be a key contributor and facilitator of strategic initiatives to optimize clinical trial start-up and comprehensive clinical trial support for clinical departments and principal investigators across multiple therapeutic areas.As a subject matter expert, the Analyst serves as the liaison between the CTO trial start-up team, physician investigators and clinical research teams across UW, and industry sponsors. This position serves as a mentor to team members in integrating regulatory, financial, and contractual start-up processes, evaluating feasibility, and employing best practices in negotiations with industry biotech and biopharma sponsors. This position will support leadership in identifying and executing opportunities to enhance services to deliver on UW Medicine strategic goals. The Trial Start-up Analyst must have strong leadership skills and be able to work collaboratively in a fast-paced environment with internal and external stakeholders.This position is a part of the CTO Operations Leadership groups and reports to the Trial Start-up and Special Projects Manager.**Position Impact to the University**Clinical Trials Office is a central clinical research operation with compliance responsibilities and services across the vast portfolio of clinical trials in UW Medicine. The CTO operation has direct impact on UW reputation with major global biotech and biopharma sponsors, the availability of funded clinical trial opportunities in UW pipeline, and UW patients' access to novel therapies. In addition, the CTO plays a key role in mitigating institutional financial and reputational risks by ensuring strict compliance with the CMS and the FDA regulations and guidelines. The Trial Start-up Analyst is a key position in maintaining efficient, cost effective, and compliant clinical trial programs at UW Medicine.**DUTIES AND RESPONSIBILITIES****Trial Start-up Operations (50%)*** As part of strategic assessment, identify opportunities and recommend improvements to enhance services and support physician investigators and their clinical research teams.* Assist management in optimizing clinical trial start-up processes and services, from site selection to open to accrual, including, but not limited to trial feasibility, submission requirements, trial start-up meetings, financial, regulatory and contractual start-up.* Support the negotiation of industry-sponsored study budgets and contribute to strategic financial planning.* Maintain alignment between contractual terms, budgetary needs, and regulatory documents to ensure productive and efficient collaboration in alignment with CTO and UW Medicine goals and KPI targets.* In collaboration with the Manager, develop and implement strategies to achieve and maintain high quality service and goals.* Provide feedback to the Manager in the scaling, staffing, and performance evaluation processes.* Analyze clinical trial financial systems and operational workflows to optimize financial performance and productivity.* Support leadership in maintaining transparency regarding study status with study teams and internal partners throughout the start-up process.* Implement document version control to ensure maintenance of internal tools, guidelines, and work instructions needed to streamline integration and standardization of comprehensive start-up operations.* Serve on internal and external committees, both within UW and in collaboration with external partners.**Mentorship and Training (30%)*** Provide training and education to CTO colleagues, School of Medicine investigators, research staff and practice site staff on CTO services, clinical trial start-up, regulatory requirements, research budgeting, billing policies, procedures, and resources.* Mentor team members in best practices for evaluating clinical trial feasibility and clinical trial complexity, required engagement and communication with internal stakeholders, and appropriate effort budgeting.* Serve as resource and mentor while monitoring deadlines, promoting standardization, and providing clinical trial start-up best practices.* Provide training and mentorship to CTO Budget and Regulatory teams regarding procedures, policies, and trial budget negotiation processes.**Special Projects (20%)*** Support CTO leadership in developing strong and productive partnerships with industry sponsors.* Implement new strategic initiatives and support operationalization of new services.* Maintain efficiency and transparency with study teams while working on these special assignments.* Contribute to the development and maintenance of the CTO website content, training materials and SOPs.* Participate in internal and interdepartmental projects and working groups as assigned.**MINIMUM REQUIREMENTS*** Bachelor’s degree in science, business, healthcare administration or related field and at least four years’ experience with coverage analysis, clinical trial budget development and negotiation, clinical research study coordination or management, health system operations, or other related research or healthcare experience.* Demonstrated team leadership skills. Ability to make positive contributions and work effectively and efficiently in a group environment.* Budget development and negotiation expertise.* Experience managing clinical trial start-up teams and processes.* Working knowledge of the Medicare Clinical Trials Policy and other Federal, State, and institutional clinical research regulations.* Exceptional customer service skills.* Strong written and oral presentation skills. Ability to understand and convey complex policy, financial and scientific/technical information in a manner that is understandable to a wide audience.* Ability to teach and mentor others in group settings, in one-on-one sessions and remotely.* Ability to prioritize and organize work independently in a fast-paced, high-volume setting.* Demonstrated skill in using Microsoft Word, Excel, PowerPoint and OnCore CTMS.**DESIRED QUALIFICATIONS*** Master’s degree in healthcare, research sciences, business administration, or related field strongly preferred.* Experience working in UW systems, specifically, SAGE, Workday, and Zendesk.* Working knowledge of sponsor types and differing sponsor requirements.**Compensation, Benefits #J-18808-Ljbffr