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. All of which has allowed the UW to be nationally recognized as a “Great College to Work For” for six consecutive years.
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 Phase 1 Program in the Division of Medical Oncology (www.seattlecca.org/research/phase1-program). This position works with the Phase I Program faculty to facilitate Phase 1 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 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 Phase I Program's strategic plan. Assist with organized improvement efforts and use problem solving and interpersonal skills to resolve bottlenecks in research implementation.
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 procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Phase 1 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 independently and in a resourceful manner to expedite the Phase 1 Program's research objectives. This position is also responsible for organizing 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 research projects managed by this position are complex. The Phase I Program first in human oncology trials enroll patients from multiple cancer areas who experience increased frequency of toxicity and require an extraordinary level of clinical knowledge as compared to most other oncology trials. In addition, these Phase I studies have extremely complex visit schedules which require a higher level of coordination skills.
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 Phase 1 Program in Division of Oncology. It is responsible for overseeing the management of up to 10 Phase I, first in human, oncology clinical trials.
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 Phase I Program first in human oncology clinical trials. Work with internal and external physicians to screen patients and indentify therapeutic pathways that optimize patient's clinical trial participation opportunities. Communicate with sponsors to get approval to enroll patients.
Manage complex Phase I 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. Perform clinical tests per protocol (vital signs, EKGs). Conduct interviews with patients to collect resarch data per protocol. Assist in monitoring patient toxicities and interacting closely with clinical providers to ensure patient safety and protocol adherence. Communicating protocol requirements 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.
Independently develop and implement Phase I first in human 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).
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, cardiology, otorhinolaryngology) to ensure that projects are executed successfully and completed within required time frames to meet research objectives.
Oversee processing of labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal and institutional biologics shipping regulations.
Communicate with sponsor to give patient status updates, and get approval for unplanned protocol procedures.
Ensure protocol compliance by managing patient appointments and coordinating with patient’s clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data.
Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patient’s clinical providers.
Initiate and maintain communication with outside physicians who refer patients to UWMC for Phase I Program oncology clinical trials.
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. Assist with data analysis and manuscript preparation.
This position will work with clinical research involving human subjects within UW Medicine and therefore clinical Research Study Coordinator training is required. The training requirements for this position include UW Medicine specific as well as general training
Assist in developing clinical research protocols that clearly describe the research objectives and procedures necessary to test the hypotheses of the research project.
Write informed consent documents that clearly describe the nature and risks of the research project in language that is easily understandable to the individual patient.
Work with multiple UW, SCCA, and Fred Hutchinson Cancer Research Center (FHCRC) groups (e.g. UW Grant and Contract Services, UW Human Subjects Review Committee, UW and SCCA Radiation Safety Committee, UW and FHCRC Biosafety Committee, SCCA Clinical Trials Planning Committee and UWMC General Clinical Research Center) to ensure timely implementation of each research project.
Manage complex clinical research protocols successfully and meet all regulatory and compliance guidelines. Develop key research collaborations with internal and external partners.
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.
Involve physician leadership as appropriate to identify and ameliorate bottlenecks with clinical trial implementation. Use problem solving and interpersonal skills to assist with organized process improvement efforts.
Although not responsible for the supervision of staff, this position is expected to mentor less experience staff within the Phase I Program as directed with the Phase I Program Research Manager.
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 related field plus three or more years of experience in clinical trial management in an oncology medical research setting or an equivalent combination of education and experience.
Thorough knowledge of IACUC, IRB, HIPAA, and FDA regulatory requirements for the conduct of research. Experience in working with UW/FHCRC/SCCA settings.
Strong collaborative 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.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
ACRP certification. Experience in Phase I oncology clinical trials.
Experience in Phase I oncology clinical trials.
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 or telephone for most 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.
This position is located in a clinical and research environment that is located at the Seattle Cancer Care Alliance and the Fred Hutch.
This position requires a flexible work schedule. Stringent deadlines from sponsor organizations to meet deadlines may require overtime. Occasional evening and weekend, as well as travel to study meetings are required.
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.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.