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The Division of Medical Oncology in the Department of Medicine has an outstanding opportunity for a full-time Senior Research Coordinator.
The purpose of this Senior Research Coordinator position is to promote the research objectives of the Hematologic Malignancy Program in the Division of Oncology. This position will be responsible for clinical trial start up in the Hematologic Malignancy Program and will also serve as the primary coordinator on new and on-going clinical trials. This position will accelerate clinical trial study start up by developing and optimizing new and ongoing processes. This position will oversee and coordinate the submission of a wide range of study start-up documents including pricing requests to various UW, SCCA, and FHCRC departments, developing study budgets, and staying current with numerous University, sponsor, and FDA policies, guidelines, and related procedures. This position will also serve as the primary Research Coordinator facilitating investigator-initiated and pharmaceutical-sponsored clinical trials.
This position is required to use independent judgment, leadership and knowledge of the academic clinical trials to effectively facilitate the work flow and promoting a collaborative work environment. The position will maintain dynamic communication with the study investigators, research staff, numerous University departments, SCCA departments, and the FHCRC departments, other development partners (other universities, federal, and industry partners). This position is supervised by and reports to the Hematologic Malignancy Research Manager.
This position is constantly required to integrate information from multiple sources to ensure smooth and expeditious start-up of clinic trials and that all the clinical trials meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor. 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 Division's research objectives. 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 analysis for the Lymphoma Program in the Division of Oncology. It is responsible for overseeing the clinical trial start up process and management of multiple clinical trials, the majority of which provide significant financial support for the Division of Oncology. In the Hematologic Malignancy group, this translates into $2.3 million dollars.
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 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.
Manage clinical trial start-up processes
Establish and maintain methods to initiate study start-up budget planning.
Use knowledge of clinical research, medical terminology, and clinical processes to translate complex oncology protocol requirements into clinical trial budgets and facilitate submissions to relevant compliance offices.
Working with the Research Managers and faculty, establish methods to translate study start-up pricing and budget efforts into study tracking tools, to streamline the invoicing of sponsors based on patient accrual and visits.
Forecast, track and report study start-up timelines.
Develop and track study start-up pieces and report progress to Research Managers, faculty, and study team members.
Produce monthly and quarterly study start-up metric reports using established formats.
Independently develop and implement research project procedures and tools 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). Communicate research requirements effectively with all providers involved in patient care
Design, develop, document and maintain policies and procedures for protocol implementation to ensure that research execution meets Good Clinical Practice guidelines. Design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that satisfies research objectives. Design, document and implement procedures for audits to assure protocol compliance and to ensure research data quality. Develop and implement corrective action plans to ensure protocol adherence and data integrity.
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. Initiate and maintain communication with outside physicians who collaborate in the care of patients on UWMC/SCCA oncology clinical trials
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.
Bachelor's Degree in Biology or Health-related field plus a minimum of 3 year experience in clinical research project coordination
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Knowledge of FDA and NIH requirements relating to research involving human subjects, experience in clinical trial development, implementation and analysis, excellent written and verbal communication skills, experience with Microsoft Office. Experience in working in clinic with patients, with at least two years of experience in solid tumor oncology and hematology. Being able to work in fast-pace 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.
Experience developing clinical trial budgets
Experience in oncology clinical research
Experience in an academic environment
CONDITIONS OF EMPLOYMENT
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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