Research - Laboratory/Non-Laboratory, Staff/Administrative
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The Division of Medical Oncology in the Department of Medicine has an outstanding opportunity for a full-time Research Coordinator.
The purpose of this position is to promote the research objectives of the Division of Oncology in the Thoracic, Head & Neck Oncology Clinical Trials Research Program. This position works with Division of Medical 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 independently designing and implementing multiple research projects to test the hypotheses in human subjects. In collaboration with the Research Manager and Physician Leadership, identify and implement initiatives in support of the Program Strategic Plan. Assist with organized improvement efforts and use problem solving and interpersonal skills to resolve bottlenecks in research implementation.
The research projects managed by this position are complex. 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 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 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 significant contributions to research development, implementation and analysis 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.
Research Patient Management
Communicates with external patients and/or physicians who are interested in thoracic, head & neck clinical trials. Works with internal and external physicians to screen patients and identify therapeutic pathways that optimize patient's clinical trial participation opportunities.
Reviews and comprehends complex protocols. Reviews and develops a familiarity with the protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, schedule of assessments, etc. Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, etc.
Manages the day to day activities of the protocol including problem solving, communication and protocol management. Manages complex protocol appointments, orders tests and procedures to facilitate protocol adherence, billing compliance, and accurate and reliable data. Participates in consenting of patients with providers. Escorts patients to protocol appointments. Educates patients about study requirements and visit schedule. Oversee that clinic tests are done per protocol (e.g. vital signs, EKG’s, research samples). Conducts interviews with patients to collect research data per protocol. Assists in monitoring patient toxicities and interacts closely with clinical providers to ensure patient safety and protocol adherence. Communicates protocol requirements for treatment modifications to providers.
Coordinates with multiple departments and organizations to ensure that clinical research and related activities are performed in accordance with federal regulations and University and sponsoring agency policies and procedures. Cooperates with University and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
Understands clinical trial budget and billing plan for patients enrolled on clinical trials. Works with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance. Assists in financial audits as necessary. Communicates with investigators and research staff when financial milestones have been met.
Independently develops and implements 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 (e.g. investigator financial disclosure requirements of the FDA).
Designs, develops, documents, and maintains policies and procedures for protocol registration and implementation to ensure that research execution meets good clinical practice guidelines. Designs, creates, and revises research instruments (e.g. case report forms) as necessary to ensure quality data that correlates with research objectives. Designs, documents, and implements procedures for protocol audits to assure protocol compliance and to ensure research data quality. Takes action to correct problems such as deviation from protocol requirements to ensure research quality. Works with departments outside of the Division of Oncology (e.g. Radiology, cardiology, Anatomic Pathology, etc.) to ensure that projects are executed successfully and completed within required time frames to meet research objectives.
Communicates with sponsor to give patient status updates, and get approval for unplanned protocol procedures.
Analysis and Reporting
Prepares interim reports for principal investigators, industry sponsors, and Institutional Review Board to ensure that each project is moving toward timely completion. Assists with data analysis and manuscript preparation.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Bachelor's Degree in life sciences and minimum of 2 years experience in clinical research
Knowledge of FDA and NIH requirements relating to research involving human subjects, experience in research implementation and data analysis, 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.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Previous experience working with oncology patients.
Previous experience conducting research in a hospital or academic setting.
CONDITIONS OF EMPLOYMENT
Fast-paced office environment, with a high volume of often-complex projects. The work is deadline driven and requires rapid and frequent communications, not only between individuals, but also by computer and/or telephone for much of the day. Projects may require travel between affiliate locations. Work week regularly exceeds 40 hours per week.
The position is located in a clinical and research environment that is located at the Seattle Cancer Care Alliance on the Fred Hutchison Cancer Research Center. Travel to/from campus buildings is required. Position requires the ability to lift study binders and materials as needed as they may be stored away from immediate desk.
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 Workforce 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.
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