Req #: 229823 Department: DEPARTMENT OF MEDICINE: HEMATOLOGY & ONCOLOGY Job Location: Seattle - Other Posting Date: 01/05/2024 Closing Info: Open Until Filled Salary: $5,500 - $7,500 per month Other Compensation: Shift: First Shift Benefits: As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here.
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.
Department of Medicine: Hematology and Oncology has an outstanding opportunity for Research Coordinator.
Position Purpose
The purpose of this position is to promote the research objectives of the Gynecologic Oncology (GynOnc) Program in the Division of Hematology and Oncology. This position works with faculty in the Divisions of Hematology and Oncology and Gynecologic Oncology to facilitate all phases of pharmaceutical-sponsored, cooperative group, investigator-initiated clinical trials and design hypotheses to be tested. This position is responsible for implementing multiple research projects to test the hypotheses in human subjects.
Position Complexities
This position is constantly required 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 develops procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the GynOnc Program. There are multiple resources available within the University system (e.g. Grant and Contract Services,Institutional Review Board, Office of Industry Relations) to help in this process, but ultimately, the work must be done independently and in a resourceful manner to expedite the GynOnc Program's research objectives. This position is also responsible for organizing and facilitating sponsor-initiated, FDA-initiated, and institution- initiated audits of study data. Finally, this position interacts with representatives from pharmaceutical companies, health care providers and terminally ill patients in a manner that well-represents the University of Washington and its associated institution, the Fred Hutchinson Cancer Center (FHCC). This position is supervised by and reports to the Clinical Research Program Manager.
Position Dimensions and Impact to the University
The mission statement of the University of Washington Medical Center states that the Medical Center serves as a research resource, providing an environment in which clinical research may be conducted. This position is essential to that mission. This position provides significant contributions to research development, implementation and analysis for the GynOnc Program and is responsible for overseeing the management of clinical trials, the majority of which provide significant financial support for the Division of Hematology and Oncology. At any one time up to 100 oncology patients from various Phase I, II and III oncology trials will be enrolled on these clinical trials.
Duties and Responsibilities
This position must be able to work independently on multiple research projects without benefit of written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, physicians, the U.S. Food and Drug Administration, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. Up to 15 projects will be in progress simultaneously, with the expectation of additional projects in the future.
RESPONSIBILITIES:
Protocol Management – 35 %
• With minimal guidance coordinate 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).
• Work with Lead Coordinator and Research Manager to design, develop, document and maintain policies and procedures for protocol registration and implementation to ensure that research execution meets good clinical practice guidelines.
• Develop, document and maintain procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.
• Design, create and revise research instruments (e.g., AE logs, study visit trackers and worksheets, case report forms) as necessary to ensure quality data that correlates with research objectives.
• Design, document and implement procedures for protocol audits to assure protocol compliance and to ensure research data quality.
• Create and maintain complete source documentation for patients on assigned studies.
• Work with Regulatory Coordinator to ensure that reporting to the Institutional Review Board (IRB) and study sponsors are timely, accurate and satisfy applicable regulation.
• With minimal guidance, develop and implement corrective action plans to ensure protocol adherence and data integrity.
• Take action to correct problems such as deviation from protocol requirements to ensure research quality.
• Work collaboratively with research team to ensure that projects are executed successfully and completed within needed time frames to meet research objectives.
• Assist in preparing and conducting sponsor monitoring visits.
• Serve as protocol expert for assigned studies.
Patient Management - 35%
• Ensure protocol compliance by managing patient appointments and coordinating with patient’s clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data.
• Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patient’s clinical providers.
• 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. Initiate and maintain communication with outside physicians who refer patients for GynOnc Program clinical trials.
Data Management – 20%
• Retrieves data from patient charts and/or source documents, abstracts information from complex medical records and reports for entry into sponsor provided case report forms. Case report form may be paper based or electronic. CRF completion and data entry responsibility may be shared with other team members, necessitating accurate and timely communication with all team members.
• Prepares source data documents to collect/support all data associated with research protocols.
• Work independently 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).
• Work professionally with sponsor representatives to review and correct data recorded in the case report forms.
• Exercise independent judgment on query resolutions.
Other - as relates to above responsibilities – 10%
• Promotes a proactive and professional relationship with internal and external staff and affiliates.
• Maintains strictest confidentiality.
• Actively participates in meetings and/or training as required.
• Serves as subject matter and protocol expert for assigned studies.
• Works with Manager and fellow team members to ensure adequate staffing levels for Program, including helping to cover sick call, vacations, etc.
• Responsible for maintaining computer spreadsheets and databases for research studies.
• Understand research study flow, work with clinic staff, support services and research team as needed to implement clinical trials.
MINIMUM REQUIREMENTS:
• Bachelor's Degree in Science or Health-related field
• Minimum two years of experience in human subjects research, research implementation or data analysis and entry
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
ADDITIONAL REQUIREMENTS:
• Excellent written and verbal communication skills
• Intermediate or higher level skills with Microsoft Office suite
• Independent time management skills, including ability to prioritize workload
• Ability to work in a fast-paced clinical research program
• Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete it within 90 days of hire
DESIRED:
• Previous experience working with oncology patients
• Previous experience conducting clinical research in a hospital or academic setting
• Clinical Research certification from an accredited organization (ACRP, SOCRA)
WORKING CONDITIONS:
• The position is located at the Fred Hutchinson Cancer Care (FHCC) in a clinical and research environment.
• Travel to/from campus buildings is required.
• This position requires a flexible work schedule and may require work outside of normal business hours to
• meet stringent deadlines from pharmaceutical companies for protocol implementation required activities.
• Occasional travel to study meetings may be required.
Application Process:
The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready.Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.