Research - Laboratory/Non-Laboratory, Staff/Administrative
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The University of Washington's Division of Medical Oncology's 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 for a full-time Lead Research Coordinator. This position will provide research coordination and clinical trials management to the Sarcoma Research Program. At any given time, there will be approximately 30 active clinical research trials and anywhere from 5 to 10 trials in the process of being activated. This position will oversee all aspects of study coordination, including assisting with informed consent, order placement, protocol compliance, patient visits, and billing compliance. This position will be responsible for management of multiple comprehensive trials, and the mentorship of junior staff. In addition, this position will have knowledge of and represent the assigned clinical trials to the three Cancer Consortium partner institutions: the Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, and the University of Washington. This position will include management of phases I-IV industry, investigator-led, and NIH sponsored research studies.
This position is required to use independent judgement, leadership, and knowledge of the academic clinical trial operations processes to effectively facilitate work flow, and promote a collaborative work environment. This position will maintain dynamic communication with study investigators, research staff, numerous University departments, clinical trial participants, SCCA departments, FHCRC departments, federal agencies, and industry partners. This position may be responsible for independently designing and implementing multiple research projects to test the hypotheses in human subjects and facilitate laboratory correlative work.
This position is supervised by and reports to the Research Manager for the Sarcoma Program.
This position will work with minimal supervision in performing assignments, and will work closely with the Research Manager, Research Coordinators, Regulatory Coordinators, and Fiscal Analysts in making decisions within University Guidelines, and ensuring that all work is carried out in a timely and efficient manner.
This position is constantly required to integrate information from multiple sources to ensure that all clinical trials are maintaining appropriate conduct, and meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor. This position requires independent decision making on all aspects of clinical trial management. This position is required to coordinate efforts across the Alliance partners, including UWMC, FHCRC, SCCA, and Harborview, as needed.
This position will have consistent contact and interactions with clinical trial participants. 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. This position is also responsible for, in collaboration with the Research Manager, organizing and facilitating sponsor-initiated, FDA-initiated, and institution-initiated audits of study data.
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 analysis for the Sarcoma Program in the Division of Oncology. It is responsible for overseeing the management of up to 15 clinical trials, the majority of which provide significant financial support for the Division of Oncology.
Duties & Responsibilities:
This position must be able to work independently on multiple research projects without benefit of written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, physicians, the U.S. Food and Drug Administration, 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
Communicate with external patients or external physicians who are interested in referring patients to UWMC/SCCA for Sarcoma oncology clinical trials. Work with internal and external physicians to screen patients and identify therapeutic pathways that optimize patient's clinical trial participation opportunities. Communicate with sponsors to get approval to enroll patients.
Manage complex study appointments, ordering tests and procedures to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection. Participate in consenting of patients with providers. Escort patients to study appointments. Educate patients about the trial requirements and visit schedule. Conduct interviews with patients to collect research data per protocol. Assist in monitoring patient toxicities and interacting closely with clinical providers to ensure patient safety and protocol adherence. Communicating protocol requirement for treatment modifications to providers.
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 research staff when financial milestones have been met.
Clinical Research Development and Leadership
This position will have a high degree of independence in research-related administration of the program, soliciting direction from the Research Manager and the Principal Investigator(s) as required, and collaborating with a wide range of program staff in developing and implementing processes. This position will be involved in complex activities to ensure that the numerous research studies and programs simultaneously progress in a satisfactory manner. Responsibilities will include strategic planning, communications, coordination of resources across multiple projects; adherence to regulatory requirements for human subject’s research; and development/maintenance of timely and meticulous record keeping systems.
Specific activities associated with the clinical research and development management include:
Implement clinical trial initiatives in support of the strategic plan surrounding overall research in the sarcoma setting.
Oversee and assist with supervision of the day-to-day operations of investigator-initiated and industry-initiated research studies and research coordinators and research assistants.
Assist research management with clinical trial protocol development assessing and advising PIs on protocol feasibility and staff efforts. Manage successful research clinical trials and meet all regulatory and compliance guidelines.
Maintain direct communication with faculty members, UW departments, funding sponsors, and research collaborators in support of the overall research plan.
Oversee clinical trials activity in accordance with FDA regulations, ICH GCP compliance, and institution and SOPs.
Provide staff training and development opportunities during regularly occurring staff meetings and act as a liaison between study team and internal clinical groups.
Assist with the staffing and workload needs, developing feasibility reports for incoming projects, and monitoring the overall workflow of the team.
Strategize with Sarcoma program management regarding trial planning, enrollment, and effort associated with trial management.
Make recommendations on financial and operational feasibility of new research endeavors based on collaborative review with unit partners.
Evaluate existing operational procedures across regulatory, pre- and post-award activity; devise and implement new procedures as needed to ensure operational efficiency, transparency, communication and collaboration across all areas of the Sarcoma Research program.
Serve as program representative in meetings.
Protocol Development and Management
Develop and implement research project policies and procedures that meet research objectives and 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).
Design, develop, document and maintain policies and procedures for protocol registration and 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 correlates with research objectives. Design, document and implement procedures for protocol audits to assure protocol compliance and to ensure research data quality. Take action to correct problems such as deviation from protocol requirements to ensure research quality. Work with departments outside of the Division of Oncology (e.g. Radiology) to ensure that projects are executed successfully and completed within required time frames to meet research objectives.
Oversee some aspects of study start up, including but not limited to study feasibility, pharmacy integration, and site initiation/implementation.
Analysis and Reporting
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
Although not responsible for the direct supervision of staff, this position is expected to oversee day to day clinical research activities, serve in a team lead capacity, and mentor less experienced staff within Sarcoma Program as directed by Sarcoma management.
Conduct complex clinical research protocols successfully and meet all regulatory and compliance guidelines.
Develop training and educational programs for onboarding of junior staff. Participate in development and implementation of research guidelines and procedures.
Mentor and assist less experienced staff, serving as a subject matter expert for clinical research conduct.
Maintain direct communication with faculty members within and external to the Division of Oncology, UW departments, funding sponsors and research collaborators in support of individual studies and the entire research program.
This position is not directly responsible for the supervision of staff. This position is expected to mentor and oversee the day to day clinical research work of less experienced staff within Sarcoma Program. This position will contribute to the interview process for new Sarcoma research staff.
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 science or health-related field plus four or more years experience in clinical trial management in an oncology medical research setting or an equivalent combination of education/experience.
Thorough knowledge of IRB, HIPAA, and FDA regulatory requirements for the conduct of research.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Experience in working within the UW/FHCRC/SCCA/CMC settings.
Strong collaborative skills and leadership skills.
Excellent organizational skills and attention to detail.
Knowledge of clinical trials budgeting.
Ability to prioritize competing demands to successfully meet deadlines and project milestones.
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 to facilitate study start-up communication or grant funded projects. 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 Hutchinson Cancer Research Center.
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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