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The Division of Oncology has an outstanding opportunity for a Research Coordinator.
The purpose of this position is to promote the research objectives of the Genitourinary Medical Oncology (GUMO) Clinical Trials Core (CTC) in the Division. This position works with the GUMO CTC Research Manager, faculty, other research staff and clinical staff to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials. This position is responsible for the implementation and coordination of assigned research studies using Good Clinical Practices to test research hypotheses in human subjects and for the facilitation of laboratory correlative science work.
The Division of Oncology is physically located in the Seattle Cancer Care Alliance on the Fred Hutchinson Cancer Research Center campus. This position requires operational knowledge of the University of Washington, Fred Hutchinson Cancer Research Center, and Seattle Cancer Care Alliance.
A key mission of the GUMO CTC is the conduct of basic, clinical, and translational Genitourinary Oncology research. At any given time, multiple clinical treatment trials are actively accruing at the Seattle Cancer Care Alliance (SCCA) and the University of Washington Medical Center (UWMC). Under the direction of the GUMO CTC Director and Research Manager, this individual provides professional level support for clinical research studies involving human subjects.
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 includes UW Medicine-specific as well as Fred Hutchinson-specific and general training.
Protocol Management •Work with other team members to develop and 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). •Working with other team members, is responsible for the maintenance of study regulatory files and the timely completion of regulatory submissions to sponsor monitors, the FDA or other granting or contract entities to meet GCP and FDA laws and guidelines. •Design, develop, document and maintain policies and procedures for patient registration and protocol 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 satisfies research objectives. •Document and implement procedures for audits to assure protocol compliance and to ensure research data quality. •Develop and implement corrective action plans to ensure protocol adherence and data integrity. •Ensure that projects are executed successfully and completed within required time frames to meet research objectives.
Patient Management •Implement research protocols at SCCA and UWMC, integrating research and clinical requirements to ensure patient safety and protocol compliance. Communicate research requirements effectively with all providers involved in patient care. •Manage complex patient schedules. Align research requirements and clinical care to ensure collection of accurate and reliable data. •Communicate with outside physicians who are interested in referring patients to UWMC/SCCA for clinical trials. •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.
Data Management •Retrieves data from patient charts and/or source documents, abstracts information from complex medical records and reports for entry into sponsor provided case report forms. Case report form may be paper based or electronic. CRF completion and data entry responsibility may be shared with other team members, necessitating accurate and timely communication with all team members. •Prepares source data documents to collect/support all data associated with research protocols.
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. •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, and SCCA Clinical Trials Planning Committee) to ensure timely implementation of each research project
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.
Other •Promotes a proactive and professional relationship with internal and external staff and affiliates. •Maintains strictest confidentiality. •Actively participates in meetings and/or training as required. •Serves as subject matter and protocol expert for assigned studies. •Assists in the orientation and mentoring of new and existing staff in the Program. •Works with Manager and fellow team members to insure adequate staffing levels for Program, including helping to cover sick call, vacations, etc. •Additional duties as deemed qualified.
Requirements: •Bachelor's Degree in Biology or related field. •A minimum of 1 year experience in human subjects research.
Experience in research implementation or 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.
DESIRED: •Previous experience working with oncology patients. Previous experience conducting research in a hospital or academic setting.
Conditions of Employment:
•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 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 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 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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