Research Coordinator 2 - Department of Medicine, Division of Hematology & Oncology

Job Description The Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a Research Coordinator to join their Thoracic, Head, and Neck Oncology Research team. About this Opportunity Reporting to the Research Manager of the UW Thoracic, Head, and Neck Oncology (THOR) Research Team, the Research Coordinator 2 is responsible for promoting the research objectives of the Division of Hematology and Oncology in the THOR Clinical Trials Research Program. The Research Coordinator 2 will play a key role in implementing clinical trials that test new cancer therapies. This position is an intermediate level professional research coordinator and, working under moderate supervision, is required to use independent judgement, leadership and expert knowledge 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 as a member of the Clinical Research Team and with faculty, staff and departments across multiple institutions to implement and coordinate investigator-initiated and pharmaceutical-sponsored clinical trials. The Research Coordinator works on-site at the Fred Hutchinson Cancer Center (FHCC), and occasionally at the UW Medical Center, and may be eligible to be considered for a hybrid telework schedule. Key Responsibilities This position must be able to work independently under administrative direction on multiple clinical trials without benefit of written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, providers, other health care personnel (e.g., nurses, patient care coordinators, insurance companies), and patients. This position will manage multiple clinical trials, including out-patient and in-patient elements, with the expectation of additional projects in the future. Protocol Management 60% Collaborate 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). Design, develop, document and maintain processes for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines. Design, create, revise and complete research instruments (e.g., protocol visit checklists, subject trackers) as necessary to ensure quality data that correlates with research objectives. Assist with implementing procedures for protocol audit to assure protocol compliance and research data quality. Take action to correct problems such as deviations from protocol requirements to ensure research quality. Assist with creating and implementing CAPA plans. Work collaboratively with research team (data manager, regulatory coordinator, research assistant) to ensure that projects are executed successfully and completed within required time frames to meet research objectives. Patient Management - 25% Ensure protocol compliance by managing patient appointments, including proposing research specific orders within the EMR, and coordinating with patient's clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data. Support and ensure complete protocol compliance and data collection in clinic. This includes collection of adverse events, concomitant medications, administering quality of life questionnaires, or other procedures required by protocol. 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 fiscal staff when financial milestones have been met. Record and track patient protocol visits, including procedures in the CTMS system. Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patients' clinical providers and care team. Communicate with outside physicians who are interested in referring patients to UWMC/SCCA for oncology clinical trials. Analysis and Reporting 10% Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion. Attend sponsor and research program meetings and report on progress of each project. Work with the Regulatory Coordinator to ensure that reporting to Federal regulatory authorities, the Institutional Review Board and study sponsors are timely, accurate and satisfy applicable regulations. With minimal guidance, develop and implement corrective action plans to ensure protocol adherence and data integrity. Assist Regulatory Coordinator with maintaining current study documents. May perform other related duties as assigned. The needs of the Research Program and clinical trial/research portfolio with inform primary allocation of above tasks. Protocol Development 5% May assist in reviewing clinical research protocols in development to ensure research objectives and procedures necessary to test the hypothesis of the research project are clearly described. May work with multiple UW and FHCC groups (e.g., FHCC Clinical Research Support - Clinical Readiness, IDS Pharmacy, Clinical Trials Unit) to help identify operational issues and implement a research project compliantly. Required Qualifications To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration. Minimum Qualifications Applicants who do not meet these minimum qualifications WILL NOT be forwarded to the Hiring Manager Bachelor's Degree in Life sciences or related field and 2 years of experience in human subjects oncology research, research implementation, or data analysis and entry. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration. Additional Qualifications Experience in clinical trial processes, implementation of research protocols. Sound knowledge of FDA, GCP, and NIH requirements relating to research involving human subjects. Strong computer skills and competency with Microsoft Office software. Experience using electronic data capture software. Strong attention to detail and ability to multi-task, organize and prioritize multiple projects simultaneously. Excellent written and verbal communication skills. Demonstrated ability to work independently, under supervision, and be a team player. Demonstrated high motivation and flexibility, with the ability to adjust to rapidly changing priorities and new projects, while maintaining positive attitude and interactions and professional demeanor under potentially stressful situations. Preferred Qualifications Previous experience working with oncology patients Knowledge of University of Washington and Fred Hutch Cancer Center processes Previous experience conducting research in a hospital or academic setting Prior experience in solid tumor oncology research Working Conditions This position is in a clinical and research environment that is located on the Fred Hutch Cancer Center campus. Frequent travel is required to and from office, hospital, and clinic. This position requires a flexible work schedule. Work hours frequently exceed 40 hours per week and may be deadline dependent. There may be deadlines over which an individual has no control that require a flexible schedule in order to accommodate patient coordination needs, study sponsor deadlines, grant deadlines, research program needs, and faculty needs. Occasional evening and weekend work (e.g., to meet deadlines; potential travel to study meetings) may be required. This position requires frequent multi-tasking, responding and adapting to multiple requests for information (email, voicemail, fax, verbal), and triaging priorities. 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 general training. Applicants selected for this position who have not already completed training for clinical research involving human subjects or for whom certification(s) have expired will be required to complete this training. About the Team The University of Washington's Division of Hematology & Oncology includes 200+ staff members and 450+ faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Center (FHCC), and the VA Puget Sound Health Care System. As the premier hematology/oncology program in the Pacific Northwest, we balance the twin aims of innovative, life-saving research and knowledge-driven, patient-focused cancer care. Over the past 40 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. Compensation, Benefits and Position Details Pay Range Minimum: $55,944.00 annual Pay Range Maximum: $90,000.00 annual Other Compensation: - Benefits: For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/ Shift: First Shift (United States of America) Temporary or Regular? This is a regular position FTE (Full-Time Equivalent): 100.00% Union/Bargaining Unit: UAW Research About the UW Working at the University of Washington provides a unique opportunity to change lives on our campuses, in our state and around the world. UW employees bring their boundless energy, creative problem-solving skills and dedication to building stronger minds and a healthier world. In return, they enjoy outstanding benefits, opportunities for professional growth and the chance to work in an environment known for its diversity, intellectual excitement, artistic pursuits and natural beauty. Our Commitment The University of Washington is committed to fostering an inclusive, respectful and welcoming community for all. As an equal opportunity employer, the University considers applicants for employment without regard to race, color, creed, religion, national origin, citizenship, sex, pregnancy, age, marital status, sexual orientation, gender identity or expression, genetic information, disability, or veteran status consistent with UW Executive Order No. 81. To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or dso@uw.edu. Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law. 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