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The University of Washington's Division of Medical Oncology 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. 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 Research Coordinator. The purpose of this position is to promote the research objectives of the Sarcoma Program. This position works with Division of Medical Oncology faculty and staff to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials and research studies. This position is responsible for independently implementing and managing multiple aspects of clinical and research studies to test hypotheses in human subjects.
The Research Coordinator will provide research coordination efforts and clinical trials management for the Sarcoma Program. At any given time, there will be approximately 20 actively enrolling clinical research trials, and anywhere from 5-10 trials in the process of site activation. This position will oversee all aspects of study coordination, including subject identification and eligibility review, assisting with informed consent, order placement, protocol compliance, subject visits, billing compliance, regulatory affairs, and general clinical trial oversight. This position will be responsible for the management of several comprehensive trials. This position will be expected to have knowledge of and represent the assigned clinical trials to the Cancer Consortium partner institutions. This position will include management of Phases I-IV industry, investigator-sponsored, and NIH sponsored research efforts.
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 will work with minimal supervision in performing assignments, and will work closely with the faculty, research coordinators, regulatory coordinators, and data and finance staff in making decisions and completing work within Univeristy guidelines. All work will be carried out in a timely, efficient, and professional manner. This person requires independent decision making skils, and will coordinate efforts across all Alliance partners. This position will have consistent contact and interactions with clinical trial subjects. This position will interact with pharmaceutical companies, health care providers, and terminally ill patients in a manner that well-represents the UW and associated institutions.
This position is supervised by and reports to the Assistant Director of Clinical Research Operations for the Sarcoma Program.
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 many clinical trials, the majority of which provide significant financial support for the Division of Oncology.
This position must be able to work independently under administrative direction 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 15 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.
Protocol Management
Manage complex clinical research protocols successfully, ensuring all regulatory and compliance guidelines are met.
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 (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, complete 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.
Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.
Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal and institutional biologic shipping regulations.
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.
Protocol Development
Assist in developing clinical research protocols that clearly describe the research objectives and procedures necessary to test the hypotheses of the research project, as needed.
Other Projects As Assigned
Although not responsible for the supervision of staff, this position is expected to mentor less experienced staff within Sarcoma Program as directed by Sarcoma management.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
REQUIREMENTS:
Bachelor's Degree in a relevant field, and one year of experience in clinical research project coordination, laboratory research, regulatory affairs management, or other related project management role.
Additional Requirements:
Knowledge of FDA and NIH requirements
Demonstrated understanding of medical terminology.
Strong computer skills and competency with Microsoft Office software. Strong attention to detail and ability to multi-task, organize and prioritize multiple projects. Familiarity with clinical research. 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.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
DESIRED
2 years experience in clinical research project coordination, laboratory research, regulatory affairs management, or other related project management role
Oncology clinical trial coordination experience.
Knowledge of University of Washington/Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance processes.
CONDITIONS OF EMPLOYMENT
The 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.
There may be meetings or appointments 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 at the Seattle Cancer Care Alliance on the Fred Hutchinson Cancer Research Center campus. This position will include travel between affiliate sites such as UW Medical Center and Harborview Medical 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. |
