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

University of Washington•Seattle, WA

2d•$55,944 - $90,000•Hybrid

About The Position

The Department of Medicine, Division of Hematology & Oncology has an outstanding opportunity for a Research Coordinator to join their Thoracic, Head, and Neck Oncology Research team. Reporting to the Research Manager of the UW Thoracic, Head, and Neck Oncology (THOR) Research Team, the Research Coordinator 2 is responsible for promoting the research objectives of the Division of Hematology and Oncology in the THOR Clinical Trials Research Program. The Research Coordinator 2 will play a key role in implementing clinical trials that test new cancer therapies. This position is an intermediate level professional research coordinator and, working under moderate supervision, is required to use independent judgement, leadership and expert knowledge to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor. This position will work as a member of the Clinical Research Team and with faculty, staff and departments across multiple institutions to implement and coordinate 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 Life sciences or related field and 2 years of experience in human subjects oncology research, research implementation, or data analysis and entry.
Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration.
Experience in clinical trial processes, implementation of research protocols.
Sound knowledge of FDA, GCP, and NIH requirements relating to research involving human subjects.
Strong computer skills and competency with Microsoft Office software.
Experience using electronic data capture software.
Strong attention to detail and ability to multi-task, organize and prioritize multiple projects simultaneously.
Excellent written and verbal communication skills.
Demonstrated ability to work independently, under supervision, and be a team player.
Demonstrated high motivation and flexibility, with the ability to adjust to rapidly changing priorities and new projects, while maintaining positive attitude and interactions and professional demeanor under potentially stressful situations.
Clinical Research Study Coordinator (RSC) training is required. The training requirement for this position includes UW Medicine-specific as well as general training. Applicants selected for this position who have not already completed training for clinical research involving human subjects or for whom certification(s) have expired will be required to complete this training.

Nice To Haves

Previous experience working with oncology patients
Knowledge of University of Washington and Fred Hutch Cancer Center processes
Previous experience conducting research in a hospital or academic setting
Prior experience in solid tumor oncology research

Responsibilities

Collaborate to develop and implement research project procedures that meet research objectives and ensure compliance with all aspects of Institution, Federal Drug Administration (FDA), and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g., investigator financial disclosure requirements of the FDA).
Design, develop, document and maintain processes for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.
Design, create, revise and complete research instruments (e.g., protocol visit checklists, subject trackers) as necessary to ensure quality data that correlates with research objectives.
Assist with implementing procedures for protocol audit 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.
Work collaboratively with research team (data manager, regulatory coordinator, research assistant) to ensure that projects are executed successfully and completed within required time frames to meet research objectives.
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.
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.
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, including procedures in the CTMS system.
Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patients' clinical providers and care team.
Communicate with outside physicians who are interested in referring patients to UWMC/SCCA for oncology clinical trials.
Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion.
Attend sponsor and research program meetings and report on progress of each project.
Work with the Regulatory Coordinator to ensure that reporting to Federal regulatory authorities, the Institutional Review Board and 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 Regulatory Coordinator with maintaining current study documents.
May perform other related duties as assigned. The needs of the Research Program and clinical trial/research portfolio with inform primary allocation of above tasks.
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.
May work with multiple UW and FHCC groups (e.g., FHCC Clinical Research Support - Clinical Readiness, IDS Pharmacy, Clinical Trials Unit) to help identify operational issues and implement a research project compliantly.