CLINICAL TRIAL BUDGET COORDINATOR (PROJECT/TEMPORARY)

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.

At the University of Washington, diversity is integral to excellence. We value and honor diverse experiences and perspectives, strive to create welcoming and respectful learning environments, and promote access, opportunity and justice for all.

The University of Washington Department of Medicine’s Division of Medical Oncology includes 41 faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Research Center, the Seattle Cancer Care Alliance, and the VA Puget Sound Health Care System. Over the past 25 years, members of the Division have developed the world's leading bone marrow transplant program. In addition, members of the Division have made substantial contributions to many other areas of cancer treatment, including the use of tumor vaccines, cellular therapy for cancer, antibody-based treatments, and novel forms of chemotherapy and hormonal therapy. Our Division is deeply committed to maintaining its position as one of the leading centers for research and treatment of cancer in the world.

The Division of Medical Oncology has an outstanding opportunity open for a Temporary Clinical Trial Budget Coordinator.

This position is responsible for clinical trial budget development for Phase 1 Program in the Division of Medical Oncology.  This position will accelerate clinical trial study start-up of new and amended clinical trial protocols by developing budgets and forecasts, pre-review evaluations, and development of clinical trial portfolio including both investigator-initiated and Sponsored trials. This position will ensure adherence to start-up processes and procedures among various UW, and FHCC departments, including the UW Clinical Trial Office, FHCC Clinical Operations Research Services and FHCC Clinical Research Support and Clinical Trial Management System.

This position is required to use independent judgment and knowledge of the academic clinical trial business to effectively facilitate the workflow and promoting a collaborative work environment.  The position will maintain dynamic communication with the study investigators, research staff, numerous University departments, FHCC departments, and other development partners (other universities, federal, and industry partners).  This position is supervised by and reports to the Phase 1 Program Business Manager.

This position is constantly required to integrate information from multiple sources to ensure that post award administration meets the requirements of the University and external agencies, institutions, and industry.  This position is required to coordinate efforts and provide information across the Alliance partners including UWMC, Fred Hutch Cancer Center, and Harborview departments and staff.

The mission statement of the University of Washington Medical Center states that the Medical Center serves as a research resource, providing an environment in which clinical research may be conducted.  This position is essential to that mission.  This position provides significant contributions to research development, implementation for the Division of Oncology.  It is responsible for overseeing the coordination of clinical trials, the majority of which provide significant financial support for the Division of Oncology.  Furthermore, at any one time up to 100 oncology patients from various Phase I oncology trials will be enrolled on these clinical trials.

Duties and Responsibilities

This position is key to the success of the Phase 1 Program and promotes timely study start-up oncology clinical trials.  It will require a strong partnership with faculty and staff within and external to the programs.

Clinical Trial Budget Development - 75%

• Establish and maintain methods to initiate study start-up budget planning
• Work with Lead Coordinator to develop and study budgets throughout the lifecycle of the clinical trial including budget and contract amendments
• Use knowledge of clinical research, medical terminology, and clinical processes to ensure clinical trial budget accurately reflects impact to UW and Fred Hutch Cancer Center departments.
• Identify protocol requirements that will impact clinical trial budgets.
• Working with the Research Manager and faculty, establish methods to translate study start-up pricing and budget efforts into study tracking tools, to streamline the invoicing of sponsors based on patient accrual and visits

Clinical Trial Start-up - 15%

• Assist with forecast, track and report study start-up timelines.
• Develop and track study start-up pieces and report progress to Research Managers, faculty, and study team members.
• Produce monthly and quarterly study start-up metric reports using established formats.

Protocol implementation - 10%

• With minimal guidance, develop and implement research project procedures and tools that meet research objectives and ensure compliance with all aspects of Institution, Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA). Communicate research requirements effectively with all providers involved in patient care.
• Design, develop, document and maintain policies and procedures for protocol implementation to ensure that research execution meets Good Clinical Practice guidelines. Design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that satisfies research objectives. Design, document and implement procedures for audits to assure protocol compliance and to ensure research data quality. Develop and implement corrective action plans to ensure protocol adherence and data integrity.
• Perform other duties as assigned.

Required

• Bachelor's Degree in Science-related field or Business or Data
• One year of experience with clinical research budget development, clinical research coordination, related research or healthcare experience
• Ability to work effectively and efficiently in a group environment
• Exceptional organizational and customer service skills
• Effective and professional oral and written communication skills
• Ability to communicate effectively with all levels of faculty, management and clinical research staff
• Thorough knowledge and ability to convey complex policy, financial and scientific/technical information in a manner that is understandable to a wide audience
• Outstanding attention to detail and problem-solving skills
• Maintain a high degree of confidentiality and professionalism
• Ability to prioritize and organize work independently
• Demonstrated skill in using Microsoft Outlook, Word, and Excel

Desired

• Experience in an academic medical center
• Experience in clinical or lab setting
• Familiarity with UW Financial Systems
• Familiarity with interpreting regulatory and contractual documents, identifying and resolving ambiguities, negotiating pricing and payment terms, and interpreting complex implications of research protocols
• Knowledge of the Medicare Clinical Trials Policy and other federal, state and institutional clinical research regulations
• Experience with using International Classification of Diseases, 10th Revision (ICD-10), Current Procedural Terminology (CPT), and Healthcare Common Procedure Coding System (HCPCS) billing codes in a clinical research environment
• Strong working knowledge of Microsoft Office Suite and Adobe Acrobat

Working environmental Conditions

• Fast-paced office environment with high-volume tasks. The work requires rapid and frequent communications, not only between individuals, but also by emails for much of the day and occasionally deadline driven.
• The position is located in a non-clinical building within the Fred Hutch Cancer Center campus.
• This position requires a flexible work schedule.  Stringent deadlines from sponsor organizations/companies to meet deadlines may require overtime including occasional evening and weekend overtime.

Application Process:

The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process.  These assessments may include Work Authorization, Cover Letter, and/or others.  Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.