University of Washington · 7 hours ago
Research Coordinator 2 (NE S UAW Research)
Greater Seattle Area
Full-time
Onsite
Entry, Mid Level
$65K/yr - $85K/yr
2+ years expThe University of Washington is seeking a full-time Research Coordinator 2 for their Division of Hematology & Oncology. This role is focused on promoting research objectives and coordinating clinical trials across multiple institutions, ensuring compliance with regulatory requirements and maintaining data integrity.
EducationHigher EducationUniversities
Responsibilities
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 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
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
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
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
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
Qualification
Required
Bachelor's degree in a related field and two years of relevant experience
Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration
Preferred
Previous clinical research experience or equivalent working with human subjects
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
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)
Benefits
For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/
Company
University of Washington
University of Washington is an educational institution that provides undergraduate, graduate, and research programs.
10001+ employees
H1B Sponsorship
University of Washington has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (249)
2024 (211)
2023 (159)
2022 (171)
2021 (169)
2020 (154)
Funding
Current Stage
Late StageTotal Funding
$205.35MKey Investors
Avista foundationNational Institute of Allergy and Infectious DiseasesAdvanced Research Projects Agency for Health
2025-04-21Grant· $0.01M
2024-09-13Grant
2024-08-13Grant· $21.1M
Leadership Team
Andrew S Allen
Adjunct Professor
Arthur Denny
Founder
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