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Research Coordinator
4 months ago
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.
The purpose of this position, Research Coordinator (E S 7), is to promote the research objectives of the Phase 1 Program in the Division of Hematology and Oncology. This position works with Division of Hematology and Oncology faculty to facilitate Phase 1 and other early development pharmaceutical-sponsored and investigator-initiated 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.
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 Phase 1 Program. 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 Phase 1 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 institutions (e.g. Fred Hutchinson Cancer Center).
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 Phase 1 Program in Division of Hematology and Oncology. It is responsible for overseeing the management of clinical trials, the majority of which provide significant financial support for the Division of Oncology.
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 interaction with research management, principal investigators and faculty, pharmaceutical sponsors and their representatives, research staff at collaborating institutions, other health care personnel (e.g. nurses, patient care coordinators), and patients.
Patient Management - 40%
Manage/oversee scheduling of appointments, ordering tests and procedures to facilitate protocol adherence, billing compliance and to ensure accurate and reliable data collection.
Manage patient enrollment including identification, screening, and consenting patients through all stages of a research study, including pre-enrollment and recruitment.
Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patient's clinical providers.
Oversee collection and recording of clinical data from a combination of electronic medical record systems review and participant and physician interviews.
Network with other organizations to improve study recruitment; communicate with outside physicians who are interested in referring patients for clinical trials.
Interact with patients outside of study visits via telephone, email, or written letter, to facilitate study recruitment and retention, and to ensure proper ongoing management and safety of patients who are participating in clinical research studies.
Protocol Management - 30%
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 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 correlates with research objectives.
Design, document and implement procedures for protocol audits to assure protocol compliance and to ensure research data quality.
Take action to correct problems such as deviation from protocol requirements to ensure research quality.
Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.
Analysis and Reporting - 20%
Prepare interim reports for principal investigators, industry sponsors, and Institutional Review Board to ensure that each project is moving toward timely completion.
Work professionally with sponsor representatives to review and correct data recorded in the case report forms in a very timely fashion; exercise independent judgment to resolve problems.
Manage confidential clinical research database, perform data cleaning, and maintain quality assurance processes.
Collection and abstraction of outside records to obtain all necessary clinical data (medical, surgical, laboratory, radiographic, pathology, medications) necessary for the successful conduct of studies and necessary for pre-enrollment and enrollment purposes. Meticulous maintenance of source files for all data is critical, particularly for FDA/Government audits.
Protocol Development - 10%
Assist in developing clinical research protocols that clearly describe the research objectives and procedures necessary to test the hypotheses of the research project.
Develop key research collaborations with internal and external partners.
Involve physician leadership as appropriate to identify and ameliorate bottlenecks with clinical trial implementation and management. Use problem solving and interpersonal skills to assist with organized process improvement efforts.
MINIMUM REQUIREMENTS
Bachelor's Degree in biology or health-related field
A minimum of 2 years experience in clinical, pharmacy or laboratory research project coordination, 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.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
ADDITIONAL REQUIREMENTS
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.
DESIRED QUALIFICATIONS
Previous experience working with oncology patients. A Clinical Research Certificate from one of the accredited organizations is desired.
CONDITIONS OF EMPLOYMENT
This position requires a flexible work schedule. Occasional evening and weekend is required. Stringent deadlines from pharmaceutical companies for protocol implementation and data collection may require overtime. Integrating required elements of research into complex patient schedules may also require occasional overtime.
Application Process: The application process 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 your "My Jobs" page. If you select to take it later, it will appear on your "My Jobs" page to take when you are access 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.
