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

About the role

The Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a Research Coordinator 2 to join their Hematology team.

Responsibilities

• Independently develop and implement research project instruments, policies, and procedures that meet research objectives and 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.
  • Aid 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).
• 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%
  • Protocol Development and Implementation - 15%
  • Analysis and Reporting - 5%
  • Miscellaneous/other - 5%

Qualifications

• Bachelor’s degree in biological or health sciences, public health, or a related field and two years of clinical research work experience.
  • Previous clinical research experience or equivalent working with human subjects, including sound knowledge of FDA, NIH, GCP, and HSP requirements relating to research involving human subjects.
  • Excellent written and verbal communication skills.
  • Strong computer skills, including experience using electronic data capture software and competency with Microsoft Office software.
  • Strong attention to detail and ability to multi-task, organize and prioritize multiple projects.
  • 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 attitude 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).