Research - Laboratory/Non-Laboratory, Staff/Administrative
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The Division of Medical Oncology has an outstanding opportunity for a full-time Clinical Research Coordinator. The purpose of this position is to promote the research objectives of UW Hematologic Malignancies Research Program in the Division of Medical Oncology. This position works with faculty and staff to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials, identify research problems and design hypotheses to be tested. This position is responsible for independently designing and implementing multiple research projects to test the hypotheses in human subjects and facilitate laboratory correlative work.
This position is required to use independent judgment and expert knowledge of the academic clinical trial healthcare operations to effectively facilitate the work flow and promote a collaborative work environment. The position will maintain dynamic communication with the study investigators, research staff, numerous UW,SCCA, and FHCRC departments, federal agencies and industry partners.
This position is supervised by and reports to the Research Manager of the UW Hematologic Malignancies team.
This position is 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 and implements procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Hematologic Malignancies team. There are multiple resources available within the University system to help in this process, but ultimately, the work must be done independently and in a resourceful manner to expedite the Division'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 institutions (FHCRC and SCCA).
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 compliance for clinical trials and research studies for the UW Hematologic Malignancies Research Program in the Division of Medical Oncology. This individual will be responsible for overseeing the management of up to 10 clinical trials, the majority of which provide significant financial support for the Division of Medical Oncology.
This position must be able to work independently under administrative direction on multiple research projects without benefit of written policies or procedures. This position requires daily interaction with team members, pharmaceutical sponsors, the U.S. Food and Drug Administration, health care personnel, and patients. Up to 10 projects will be in progress simultaneously, with the expectation of additional projects in the future.
Protocol, Patient, and Data Management
Under minimal guidance:
Ensure protocol compliance by managing patient appointments and coordinating with patients' clinical providers (e.g. physicians, midlevel providers, nurses, and other clinical staff) to collect reliable and accurate data per protocol requirements.
Take action to correct problems such as deviation from protocol requirements to ensure research quality. Ensure that appropriate parties are notified of any deviations.
Ensure that projects are executed successfully and completed within the needed time frames to meet research objectives.
Document, execute, and/or maintain policies and procedures for protocol/patient management to ensure that research implementation meets GCP, federal, state, institutional, and group policies and guidelines.
Complete, revise, and ensure appropriate documentation exists for research instruments (e.g. case report forms) as necessary to ensure quality data that correlates with research objectives. Maintain and complete data capture instruments.
Document and implement procedures for protocol audits to assure protocol compliance and to ensure research data quality.
May process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal and institutional biologics shipping regulations.
Understand clinical trial budget and billing plan for patients enrolled on clinical trials. Work with internal partners and provide/complete documentation to ensure clinical trials are performed in accordance with institutional requirements for billing compliance. Assist in financial audits as necessary. Communicate with investigators and research staff when financial milestones have been met.
Help ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patients' clinical providers.
Initiate and maintain communication with outside physicians who refer patients to SCCA and/or UWMC for oncology clinical trials.
Analysis and Reporting
Prepare interim reports and data as requested for the research program and sponsors to ensure that each project is moving toward timely completion.
Prepare expedited reports for review; submit completed reports to appropriate parties.
Work with research staff, faculty, external departments (may include multiple UW, SCCA, and FHCRC groups), and industry sponsors to ensure successful and timely implementation of and access to research projects as assigned.
May assist the Research Program's Regulatory Coordinators by organizing, collating, distributing, and obtaining signatures on drug safety reports and other regulatory documents.
May perform other duties as assigned. Expected to provide coverage for peers and assist in training new members to the team as appropriate. The needs of the Research Program and clinical trial/research portfolio will inform primary allocation of above tasks.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Bachelor's Degree in life sciences or relevant field and 1 year of experience with oncology clinical research required.
Sound knowledge of FDA, GCP, and NIH 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.
Familiarity in clinical trial processes, implementation of research protocols.
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.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Experience with hematologic malignancies clinical research.
Knowledge of University of Washington/Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance processes.
CONDITIONS OF EMPLOYMENT
The ability to multi-task and be flexible while maintaining a professional demeanor is crucial as priorities change throughout each day. May have to respond to multiple requests for information (e-mail, voicemail, fax, verbal), determining priorities.
Work hours frequently exceed 40 hours per week and may be deadline dependent. There may be deadlines over which an individual has no control that require a flexible schedule in order to accommodate, such as patient coordination needs, study sponsor deadlines, research program needs, grant deadlines, and faculty needs. This position is located in a clinical and research environment that is located at the Seattle Cancer Care Alliance on the Fred Hutchinson Cancer Research Center campus.
Occasional evening and weekend work (e.g. to meet deadlines; potential 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 Workforce 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.
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