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The Division of Gastroenterology has an excellent opportunity for a Research Coordinator to assist with the conduct of clinical research for multiple faculty members in the Center for Liver Investigation Fostering Discovery (C-LIFE). Under the supervision of the Research Manager, this position will be responsible for initiating study activity, including the management of compliance requirements and clinical unit activities for the research program. The person in this position will implement and facilitate clinical research studies requiring extensive collaborative efforts with funding agencies, including the NIH, private foundations, and pharmaceutical companies.
Specific responsibilities include:
Research Subject Management
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 consent of subjects through all stages of a research study including pre-enrollment and recruitment.
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.
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 at study visits to collect data; perform clinical research testing; and perform or schedule phlebotomy and/or imaging testing and/or liver biopsies and/or other testing on study subjects as needed.
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 Development & Management
Assist in developing and revising clinical research protocols that clearly describe the research objectives and procedures necessary to test the hypotheses of the research project.
Write informed consent documents that clearly describe the nature and risks of the research project in language that is easily understandable for the individual patient.
Responsible for study start-ups to include assisting with feasibility questionnaires, communications with study sponsors, completion of study sponsor forms, development, submission and revisions of informed consent forms (ICFs), working with Zipline for IRB submissions, submission of any necessary protocol modifications to the IRB and/or WIRB, work with CRBB for study start-up and ongoing study conduct, conduct submissions to WIRB, submissions to DSMBs, development and maintenance of SOPs for study protocols.
Independently develop and implement research project policies and standard operating procedures that meet research objectives 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 (e.g. investigator financial disclosure requirements of the FDA)
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, data collection forms, etc.) 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 and patient safety
Ensure that projects are executed successfully and completed within needed timeframes to meet research objectives
Obtain necessary regulatory and compliance approvals
Research Specimen Tracking and Coordination
Provide administrative and technical support for research projects, following complex instructions for processing laboratory samples for tracking, storage or shipping. Independently maintain and track laboratory sample supplies, complete requisition forms, and assemble kits for upcoming research subject visits for assigned clinical trials.
Process labs for clinical trials; ship specimens in accordance with federal and institutional biologic shipping regulations.
Independently track and process research subject blood, urine, and/or tissue samples (as dictated by protocol) following study specific guidelines for storage and/or shipping.
Blood, urine, DNA, adipose, and stool collection by the study coordinator will be required for some studies. Many samples may need to be shipped immediately by the study coordinator.
Work with Pathology to generate histologic slides for clinical and research reads and prepare for shipping for central pathology read, as well; work with Radiology to generate research images and navigate study-related protocols for image transmission for central reading
Data Coordination, Analysis and Reporting
Provide data analysis, synthesizing information from various reports and developing strategies to clearly communicate findings to the involved parties.
Manage scheduling request orders to meet study protocol needs and tight timeframes.
Independently develop study-specific research forms.
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 medical records requirements from outside medical facilities.
Prepare interim reports for principal investigators, industry sponsors and IRB to ensure that each project is moving toward timely completion.
Manage confidential clinical research database including data cleaning and quality assurance processes.
In collaboration with the PI, generate reports for granting agencies and IRB annual renewals/modifications, for sponsoring agency and for scientific presentations and manuscripts.
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 Other related duties as assigned
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 sciences, public health, or related discipline and at least two years of experience with research coordination in a hospital/clinic setting or equivalent combination of education/experience.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Familiarity with liver related diseases (NASH, Hepatitis B and C, Fatty Liver, Cirrhosis, etc.)
Familiarity with complex academic program operations with particular emphasis on the interrelationship between clinical, research and educational requirements of subspecialty medical training programs.
Familiarity with UW medical records systems and records management data systems
Proficiency in Microsoft Office, Access and Sharepoint
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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