Req #: 236196

Department: DEPARTMENT OF MEDICINE: HEMATOLOGY AND ONCOLOGY

Posting Date: 07/01/2024

Closing Info: Closes On 07/07/2024

Salary: $4,054 - $5,500 per month

Limited Recruitment: Open to Department employees only

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 research program in the Division of Hematology and Oncology. This position works with Division of Hematology and Oncology faculty to facilitate investigator-initiated and pharmaceutical-sponsored 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.

Position Complexities The University of Washington, Division of Hematology and Oncology has an excellent position for a Clinical Research Coordinator in the Melanoma/Renal Clinical Trials Research Program.

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 Division of Hematology and Oncology. 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 Division’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 institution (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 contributions to research development and implementation for the Division of Hematology and Oncology. It is responsible for overseeing the management of clinical trials, the majority of which provide significant financial support for the Division of Hematology and 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.

DUTIES AND RESPONSIBILITIES

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.

Protocol Management – 20%

• 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 and Research Manager to design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that satisfies research objectives. • Complete source documents 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 research team (data coordinator, regulatory coordinator, research assistant) to ensure that projects are executed successfully and completed within required time frames to meet research objectives.

Research Study Subject Management - 20%

• 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. • Communicate timely and accurate information to research study subjects about study participation and visits. • 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.

Data Coordination, Abstraction and Analysis – 20%

• Work with study team members to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Code and record said information into various study-specific data-capture systems (both electronic and paper-based). • Resolve and answer data queries with minimal errors. • With other study team members make judgments about the relevance of the clinical data to the research for complicated oncology research subjects. • Responsible for maintaining computer spreadsheets and databases for research studies. • Develop study-specific or program data acquisition forms in conjunction with study staff.

Regulatory Coordination - 20%

• Assist research staff with ongoing IRB and other regulatory submissions. • Assist with maintaining regulatory files and tracking systems. • Assist with organizing and filing safety reports

Research Specimen Tracking and Coordination - 10%

• Independently maintain and track laboratory sample supplies, complete requisition forms, and assemble kits for upcoming research subject visits for assigned clinical trials with minimal supervision. • Independently track and process research subject blood, urine, and tissue samples following study specific guidelines for storage and/or shipping with minimal supervision. • File requisitions and other research documentation in each patients' research chart.

Administrative - 10%

• Assist with triaging emails from shared email accounts • Work with the Melanoma/Renal Program Manager to develop process improvement tools. Assist in the assessment and design of tracking tools with the manager to develop standard practices within the Melanoma/Renal Program. • Perform related tasks as assigned • Assist program as needed to support operations of overall research program.

MINIMUM REQUIREMENTS

• Bachelor's Degree in a science-related field • A minimum of 1 year experience in the medical field

ADDITIONAL REQUIREMENTS

• Demonstrated understanding of medical terminology • Strong computer skills and experience with data entry and databases • Strong attention to detail and ability to organize work • Ability to communicate effectively both verbally and in writing, to work effectively with colleagues, research subjects, and study sponsor representatives • Demonstrated ability to work independently and to carry out complex tasks • 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

• Knowledge of Oncology practice and terminology • Prior working experience at the UWMC and/or FHCC • Competency in Microsoft Office software • Knowledge of HIPAA regulations • Knowledge of GCP (Good Clinical Practice)

CONDITIONS OF EMPLOYMENT

• The position is located in a clinical and research environment that is located at Fred Hutchinson Cancer Center. Travel to/from campus buildings is required • 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 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.