RESEARCH COORDINATOR - University of Washington

Req #: 237981 Department: DEPARTMENT OF MEDICINE: HEMATOLOGY & ONCOLOGY Appointing Department Web Address: https://hemonc.uw.edu/ Posting Date: 08/22/2024 Closing Info: Open Until Filled Salary: $5,417 - $7,084 per month Shift: First Shift Notes: As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230701\_a11y.pdf ) 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. **The Department of Hematology & Oncology has an outstanding opportunity for a Research Coordinator to join their team.** **POSITION PURPOSE** The University of Washington's Division of Hematology & Oncology includes 130+ faculty members located at the UW Medical Center, the Fred Hutchinson Cancer Center, and the VA Puget Sound Health Care System. 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. The Division of Hematology & Oncology has an outstanding opportunity for a full-time Clinical Research Coordinator. The purpose of this position is to promote the research objectives of the UW Hematology Clinical Research Program, which includes Acute Leukemia, Myeloid Neoplasms, and Classical Hematology disease indications. This position works with faculty, staff, and departments across multiple institutions to implement and coordinate multiple investigator-initiated and pharmaceutical-sponsored clinical trials. **POSITION COMPLEXITIES** This position is required to use independent judgment, leadership, and expert knowledge of the academic clinical trial healthcare operations to effectively facilitate the work flow and promote a collaborative work environment. The position will maintain dynamic communication with the study investigators, research staff, numerous UW and FHCC departments, federal agencies, and industry partners. This position is supervised by and reports to the Clinical Research Manager of the UW Hematology clinical research team. 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 and implements procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the UW Hematology Clinical Research 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 Division's research objectives. This position also supports the conduct of pharmaceutical sponsor-initiated, FDA-initiated, and institution-initiated audits of study data. Finally, this position interacts with representatives from federal and state agencies, foundations, pharmaceutical companies, health care providers, and hematology/oncology patients in a manner that well-represents the University of Washington and its associated institutions (FHCC). **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 compliance for clinical trials and research studies for the UW Hematology Clinical Research Program in the Division of Hematology & Oncology. This individual will be responsible for overseeing the management of up to 10 clinical trials of varying complexities, the majority of which provide significant financial support for the Division of Hematology & Oncology. **DUTIES AND RESPONSIBILITIES** This position must be able to work independently under administrative direction on multiple clinical trials; at times without benefit of written policies or procedures, while concurrently helping to create best practices moving forward. This position requires daily interaction with pharmaceutical sponsors, health care providers, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. This position will manage multiple clinical trials simultaneously, including out-patient and in-patient elements, with the expectation of additional projects in the future. Protocol, Patient, and Data Management - 75% + 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. + Design, develop, document and maintain policies and procedures for protocol registration and implementation to ensure research execution meets good clinical proactive guidelines. + Design, create, revise, and complete research instruments (e.g. case report forms, protocol visit checklists, subject trackers) as necessary to ensure quality data that correlates with research objectives. + Ensure that projects are executed successfully and completed within needed time frames to meet research objectives. + Prepare laboratory and specimen collection kits according to protocol and lab manual instructions. Work with different departments across UW and FHCC to collect, process, and transport specimen samples. + May process labs for clinical trials, including centrifuging and aliquoting specimens, and ship specimens in accordance with federal and institutional biologics shipping regulations. + 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. + Advise clinical staff which tests and procedures are needed during each research visit to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection. Work closely with clinical providers to ensure that study therapy is administered in accordance with the clinical protocol (e.g. dose modifications are implemented when required by the protocol). + 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. + Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patients' clinical providers and care team. + Timely and appropriate reporting of Adverse Events and Serious Adverse Events to sponsors and review boards to ensure compliance to protocol and FDA requirements. + 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 and assessments, including procedures in the Clinical Trial Management System. + Work with Regulatory Coordinator to ensure that reports to the Institutional Review Board, FDA, and/or study sponsors are timely, accurate, and satisfy applicable regulation. With minimal guidance, develop and implement corrective action plans to ensure protocol adherence and data integrity. + Assist with implementing procedures for protocol audits 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. + May initiate and maintain communication with outside physicians who refer patients to UWMC and/or FHCC for clinical trials. + Work independently and with study team members to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects. Code and record said information into various study-specific data-capture systems (both electronic and paper-based). + Prompt completion of electronic data capture systems and electronic case report forms. + Timely resolution of queries and questions from industry sponsors, contract research organizations, institutional groups and our affiliates with minimal errors. + With other study team members, make judgments about the relevance of the clinical data to the research for complicated oncology research subjects. + Responsible for maintaining computer spreadsheets and databases for research studies. + May develop study-specific or program data acquisition forms and data capture systems in conjunction with other study staff. + Request and appropriately distribute/abstract medical records from outside medical facilities. + Perform quality control activities to ensure accuracy of data collection.Protocol Development and Implementation - 15% + Use knowledge of clinical research, medical terminology, and clinical processes to interpret complex protocol requirements and identify protocol procedures that will impact clinic operations. + 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. + Work with multiple UW and Fred Hutchinson Cancer Center groups (e.g. FHCC Clinical Research Support - Clinical Readiness, IDS Pharmacy, Clinical Trials Unit, Translational Research Unit) to help identify operational issues and implement a research project compliantly. + May create informed consent documents that clearly describe the nature and risks of the research project in language that is easily understandable to the individual patient.Analysis and Reporting - 5% + Assist Investigators and study team with organization, preparation, and analysis of study data for publication and grant preparation. + Prepare interim reports for the research program and sponsors to ensure that each project is moving toward timely completion. + Attend sponsor and research program meetings and report on progress of each project. + Assist Regulatory Coordinators by preparing reports to support annual FDA submissions and IRB Continuing Review Reports.Miscellaneous/other - 5% + May develop training materials and standard operating procedures for the Research Program. + May assist in the training and onboarding of new research staff. + May perform other duties as assigned. The needs of the Research Program and clinical trial/research portfolio will inform primary allocation of above tasks. **MINIMUM REQUIREMENTS** + Bachelor's degree in life sciences or related field + A minimum of two years previous clinical research experience or equivalent working with human subjects. **Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.** **ADDITIONAL REQUIREMENTS** + Sound knowledge of FDA, NIH, GCP, and HSP requirements relating to research involving human subjects. + Experience using electronic data capture software. + Strong computer skills and competency with Microsoft Office software. + Strong attention to detail and ability to multi-task, organize and prioritize multiple projects. + 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. **DESIRED QUALIFICATIONS** + Experience or knowledge in hematology and/or oncology. + Experience or knowledge of University of Washington and Fred Hutchinson Cancer Center processes. + Experience or knowledge with Epic Systems (electronic health record). **CONDITITONS OF EMPLOYMENT** + 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. + 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, 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 on the Fred Hutchinson Cancer Center campus. Frequent travel to and from office and clinic/hospital. Sitting at a desk for majority of hours worked; working on a computer and on a telephone in a cubicle in a public area with little privacy. + Occasional evening and weekend work (e.g. to meet deadlines; potential travel to study meetings) may be required. **Application Process:** The application process 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 access 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.\#UWDeptMedicineJobs University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.