Research Coordinator 2 (NE S UAW Research)

University of Washington Medical Center•Seattle, WA

8d•Hybrid

About The Position

The Division of Hematology & Oncology has an outstanding opportunity for a full-time Research Coordinator 2. Reporting to the Clinical Research Manager, the Research Coordinator 2 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 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.
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.
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 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.