Req #: 234311

Department: DEPARTMENT OF MEDICINE: HEMATOLOGY AND ONCOLOGY

Job Location Detail: This recruitment may be used to fill multiple openings.

Posting Date: 05/17/2024

Closing Info: Open Until Filled

Salary: $5,750 - $6,781 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.

The University of Washington's Division of Hematology and Oncology includes 130+ faculty members located at the UW Medical Center (UWMC), the Fred Hutchinson Cancer Center (FHCC), and the VA Puget Sound Health Care System. Over the past 40 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 Hematology and Oncology has an outstanding opportunity for a full-time Clinical Research Coordinator. The purpose of this position is to promote the research objectives of UW Lymphoma & Myeloma Research Program in the Division of Hematology and Oncology. This position works with faculty, staff, and departments across multiple institutions to implement and coordinate multiple investigator-initiated and pharmaceutical-sponsored clinical trials.

Position Complexities This position is required to use independent judgment, leadership and expert knowledge of the academic clinical trial healthcare operations to effectively facilitate the work flow and promote a collaborative work environment. The position will maintain dynamic communication with the study investigators, research staff, numerous UW, and FHCC departments, federal agencies and industry partners.

This position is supervised by and reports to the Clinical Research Program Manager of the UW Lymphoma & Myeloma Research team.

This position is constantly required 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. This position develops and implements procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the UW Lymphoma & Myeloma Research team. 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 independently and in a resourceful manner to expedite the Division's research objectives. This position also supports the conduct of pharmaceutical 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 (FHCC).

Position Dimensions and Impact to the University 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 and compliance for clinical trials and research studies for the UW Lymphoma & Myeloma Research Program in the Division of Hematology and Oncology. This individual will be responsible for overseeing the management of up to 10 clinical trials of varying complexities, the majority of which provide significant financial support for the Division of Hematology and Oncology.

DUTIES AND RESPONSIBILITIES This position must be able to work independently under administrative direction on multiple clinical trials without benefit of written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, providers, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. This position will manage multiple clinical trials, including out-patient and in-patient elements, with the expectation of additional projects in the future.

Protocol, Patient, and Data Management - 85%

• Independently develop and implement research project policies and procedures that meet research objectives and that ensure compliance with all aspects of Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects.

• Design, develop, document and maintain policies and procedures for protocol implementation to ensure research execution meets good clinical proactive guidelines.

• Design, create, revise, and complete research instruments (e.g. protocol visit checklists, and subject trackers) as necessary to ensure quality data that correlates with research objectives.

• Assist with implementing procedures for protocol audits to assure protocol compliance and research data quality.

• Take action to correct problems such as deviations from protocol requirements to ensure research quality. Assist with creating and implementing CAPA plans.

• Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.

• May process labs for clinical trials, including centrifuging and aliquotting specimens, and ship specimens in accordance with federal and institutional biologics shipping regulations.

• Ensure protocol compliance by managing patient appointments, including proposing research specific orders within the EMR, and coordinating with patient's clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data.

• Support and ensure complete protocol compliance and data collection in clinic. This includes collection of adverse events, concomitant medications, administering quality of life questionnaires, or other procedures required by protocol.

• 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 investigators and fiscal staff when financial milestones have been met.

• Record and track patient protocol visits, including procedures in the CTMS system.

• Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patients' clinical providers and care team.Analysis and Reporting - 10%

• Prepare interim reports for the research program and sponsors to ensure that each project is moving toward timely completion.

• Attend sponsor and research program meetings and report on progress of each project.

• Assist Regulatory Coordinators by preparing reports to support annual FDA submissions and IRB Continuing Review Reports.

• May perform other duties as assigned. The needs of the Research Program and clinical trial/research portfolio will inform primary allocation of above tasks.Protocol Development - 5%

• May assist in reviewing clinical research protocols in development to ensure research objectives and procedures necessary to test the hypothesis of the research project are clearly described.

• May work with multiple UW and FHCC groups (e.g. FHCC Clinical Research Support - Clinical Readiness, IDS Pharmacy, Clinical Trials Unit) to help identify operational issues and implement a research project compliantly. MINIMUM REQUIREMENTS

• Bachelor's Degree in Life or Social Sciences or related field

• A minimum of 2 years clinical research project coordination experience or equivalent. Sound knowledge of FDA, GCP, and NIH requirements relating to research involving human subjects. Experience using electronic data capture software.

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

• Strong computer skills and competency with Microsoft Office software.

• Strong attention to detail and ability to multi-task, organize and prioritize multiple projects.

• Experience in clinical trial processes, implementation of research protocols.

• Excellent written and verbal communication skills.

• Demonstrated ability to work independently, under supervision, and be a team player.

• Should be highly motivated and flexible, with the ability to adjust to rapidly changing priorities and new projects.

• Maintain positive vision, sense of humor, and professional demeanor under potentially stressful situations.

• Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete this training. DESIRED QUALIFICATIONS

• Oncology clinical trial coordination experience.

• Knowledge of University of Washington and Fred Hutchinson Cancer Center processes. CONDITIONS OF EMPLOYMENT

• Ability to multi-task and be flexible while maintaining a professional demeanor is crucial as priorities change throughout each day.

• May have to respond to multiple requests for information (e-mail, voicemail, fax, verbal), determining priorities.

• Work hours frequently exceed 40 hours per week and may be deadline dependent.

• There may be deadlines over which an individual has no control that require a flexible schedule in order to accommodate, such as patient coordination needs, study sponsor deadlines, research program needs, grant deadlines, and faculty needs.

• This position is located in a clinical and research environment that is located on the Fred Hutchinson Cancer Center campus.

• Frequent travel/to and from office and clinic.

• Occasional evening and weekend work (e.g. to meet deadlines; potential travel to study meetings) may be 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 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 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.