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

University of Washington Medical Center•Seattle, WA

1d•$65,352 - $85,200•Hybrid

About The Position

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

Requirements

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.
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.

Nice To Haves

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).

Responsibilities

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).
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.
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 and assist in the training and onboarding of new research staff.
May perform other related duties as assigned.