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

Job DescriptionThe Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a Research Coordinator 2 to join their Hematology team.About this OpportunityReporting to the Clinical Research Manager, the Research Coordinator is responsible for promoting 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 patients, departments across multiple institutions, and with a variety of sponsors and stakeholders – faculty, staff, physicians, the U.S. Food and Drug Administration, and other health care personnel (e.g. nurses, patient care coordinators, insurance companies) – to implement and coordinate multiple 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 ResponsibilitiesThis 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 instruments, 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.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. Record and track patient protocol visits and assessments, including procedures in the Clinical Trial Management System.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 patient safety and 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.Work with the Regulatory Coordinator to ensure that reports to the Institutional Review Board, FDA, and/or 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.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).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.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.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 the 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 and assist in the training and onboarding of new research staff.May perform other related duties as assigned. The needs of the Research Program and clinical trial/research portfolio will inform primary allocation of above tasks.Required QualificationsTo 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 ex