Research Coordinator

Overview

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 Division of Hematology & Oncology has an outstanding opportunity for a full-time 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. 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 and have contributed to many other areas of cancer treatment.

This position must be able to work with limited supervision on multiple research projects, occasionally without written policies or procedures, while helping to create best practices moving forward. This position requires daily interaction with sponsors, physicians, the U.S. Food and Drug Administration, other health care personnel, and patients. Up to 10 projects will be in progress simultaneously, with the expectation of additional projects in the future.

• Protocol Management and Regulatory (50%)
  • Implement research project procedures that meet objectives and ensure compliance with institution, FDA, and NIH regulations pertaining to clinical research in human subjects.
  • Use knowledge of clinical research, medical terminology, and clinical processes to interpret standard protocol requirements and identify protocol procedures that impact clinic operations.
  • Design, develop, document, and maintain policies and procedures for protocol registration and implementation to ensure that research execution meets good clinical practice guidelines.
  • Design, create, and revise research instruments (e.g., case report forms) to ensure quality data aligned with research objectives.
  • Design, document, and implement procedures for protocol audits to assure protocol compliance and data quality.
  • Collaborate with the research team to execute projects successfully and meet required time frames.
  • Ensure timely completion of electronic data capture systems and electronic case report forms; resolve queries from sponsors, CROs, and IRB promptly.
  • Coordinate with the Regulatory Coordinator to ensure timely and accurate reports to the IRB and study sponsors; assist in corrective action plans for protocol adherence and data integrity.
  • Understand clinical trial budgets and billing plans for patients enrolled on trials; work with internal partners to ensure billing compliance and assist in financial audits.
  • Communicate with investigators and research staff when financial milestones are met.
• Study Subject Management (40%)
  • Advise clinical staff on tests and procedures needed during each research visit to facilitate protocol adherence, billing compliance, and reliable data collection.
  • Coordinate with clinical providers to ensure study therapy is administered per protocol and dose modifications are implemented when required.
  • Correct deviations from protocol to maintain research quality.
  • Prepare laboratory and specimen collection kits; coordinate across UW and FHCC to collect, process, and transport specimens.
  • Manage patient appointments to ensure protocol compliance and reliable data collection.
  • Monitor patient safety and liaise with clinical providers during trials.
  • Initiate and maintain communication with outside physicians referring patients to UWMC/FHCC for trials.
  • Report adverse events (AEs) and serious adverse events (SAEs) to sponsors and review boards in a timely manner to ensure regulatory compliance.
• Analysis and Reporting (10%)
  • Prepare interim reports for principal investigators, industry sponsors, and the Institutional Review Board to support timely project progression.
  • Clinical Research Coordinator (CRC) training is required; training may include UW Medicine-specific, Fred Hutch-specific, and general training.

Other duties as assigned.

• Bachelor’s degree in a related field and one year 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.

• Strong attention to detail and ability to multi-task, organize, and…