Req #: 230017

　　Department: DEPARTMENT OF MEDICINE: HEMATOLOGY & ONCOLOGY

　　Posting Date: 01/10/2024

　　Closing Info: Open Until Filled

　　Salary: $5,645 - $5,835 per month

　　Shift: First Shift

　　Notes: As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230701_a11y.pdf )

　　As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills and dedication to build stronger minds and a healthier world.

　　UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty.

　　POSITION PURPOSE

　　The purpose of this position is to promote the research objectives of the Melanoma, Renal Cell Carcinoma, and Merkel Cell Carcinoma Program (MEL/RCC/MCC) in the Division of Oncology. This position works with program faculty to facilitate MEL/RCC/MCC and other early development pharmaceutical-sponsored and investigator-initiated clinical trials, identify research problems and design hypotheses to be tested. This position is responsible for implementing multiple research projects to test the hypotheses in human subjects.

　　This position requires the ability to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor. With guidance this position develops procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the MEL/RCC/MCC Program. There are multiple resources available within the University system (e.g. Grant and Contract Services, Institutional Review Board, Office of Industry Relations) to help in this process, but ultimately, the work must be done with limited assistance and in a resourceful manner to expedite the MEL/RCC/MCC Program's research objectives. This position is also responsible for participating in and facilitating sponsor-initiated, FDA-initiated, and institution-initiated audits of study data. Finally, this position interacts with representatives from pharmaceutical companies, health care providers and terminally ill patients in a manner that well-represents the University of Washington and its associated institutions (FHCRC and SCCA).

　　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 contributions to research development and implementation for the Division of Oncology. It is responsible for overseeing the management 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,II and III oncology trials will be enrolled on these clinical trials.

　　This position must be able to work independently on multiple research projects with minimal written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, physicians, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. Up to 10 projects will be in progress simultaneously, with the expectation of additional projects in the future.

　　DUTIES AND RESPONSIBILITIES Protocol Management – 50 %

　　With minimal guidance implement research project procedures 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).

　　Develop, document and maintain procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.

　　Work with Data Coordinator, Research Manager, and Regulatory Coordinator to design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that satisfies research objectives. Assist data coordinators to resolve data queries. Provide source documentation to data coordinator in a timely manner.

　　Work with Regulatory Coordinator to ensure that reporting to the Institutional Review Board and study sponsors are timely, accurate and satisfy applicable regulation. With minimal guidance, develop and implement corrective action plans to ensure protocol adherence and data integrity.

　　Work collaboratively with team members to ensure that projects are executed successfully and completed within required time frames to meet research objectives.Patient Management - 40%

　　Advise clinical staff which tests and procedures are needed during each research visit to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection.

　　Work closely with clinical providers to ensure that study therapy is administered in accordance with the clinical protocol (e.g. dose modifications are implemented when required by the protocol).

　　Communicate with outside physicians who are interested in referring patients to UWMC/SCCA for oncology clinical trials.

　　Understand clinical trial budget and billing plan for patients enrolled on clinical trials. Work with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance. Assist in financial audits as necessary.

　　Communicate with sponsor to give patient status updates, and get approval for unplanned protocol procedures.

　　Communicate with patients to schedule study visits in accordance with research projects.Analysis and Reporting – 10 %

　　Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion.

　　This position will work with clinical research involving human subjects within UW Medicine and therefore clinical Research Study Coordinator (RSC) training is required. The training requirement for this position include UW Medicine-specific as well as general training.

　　Other duties as assigned. MINIMUM REQUIREMENTS

　　Bachelor's Degree in life sciences.

　　A minimum of 1 year experience in human subjects research.

　　Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. ADDITIONAL REQUIREMENTS

　　Experience in research implementation or data analysis and entry

　　Excellent written and verbal communication skills

　　Experience with Microsoft Office.Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete it within 90 days of hire. DESIRED QUALIFICATIONS

　　Previous experience working with oncology patients.

　　Previous experience conducting research in a hospital or academic setting. CONDITIONS OF EMPLOYMENT

　　This position requires a flexible work schedule. Stringent deadlines from pharmaceutical companies for protocol implementation and data collection may require overtime. Integrating required elements of research into complex patient schedules (e.g collecting and processing multiple blood specimens for pharmacokinetic sampling) may also require occasional overtime.

　　Occasional evening and weekend travel to study meetings is required. Application Process: The application process 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 your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are access 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.

　　University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.