Req #: 242187 Department: DEPARTMENT OF MEDICINE: GASTROENTEROLOGY Appointing Department Web Address: https://gastro.uw.edu/ Job Location Detail: Health Sciences Center, BB Wing, 13th Floor Posting Date: 12/23/2024 Closing Info: Open Until Filled Salary: $5,000 - $5,500 per month Shift: First Shift Notes: 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. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230701\_a11y.pdf) 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 Department Of Medicine: Gastroenterology has an outstanding opportunity for a Research Coordinator to join their team.** **POSITION PURPOSE** Under the general direction of the Liver Care Line Director Research Manager, the Center Research Coordinator will assist with the conduct of clinical research for multiple faculty members in the Center for Liver Investigation Fostering Discovery (C-LIFE). The individual in 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. The individual in this position must be highly motivated, highly reliable, and have excellent communication and organizational skills. The individual in this position must be able to successfully navigate an initial steep learning curve, and be able to work independently on multiple research projects without benefit of written policies or procedures. The successful candidate in this position must demonstrate outstanding and quick learning skills in order to keep up with the fast-paced work obligations. This position requires daily interaction with patients, pharmaceutical sponsors, physicians, Investigational Drug Services, and other health care personnel (e.g. nurses, patient care coordinators, pharmacists, insurance companies). This position requires meticulous management of data entry, regulatory documentation, and management of clinical records and clinical scheduling, as these will be monitored frequently over the duration of the clinical studies, and the coordinator’s performance in these duties will be monitored and recorded closely. As many as 5-10 projects will be in progress simultaneously, with the expectation of additional projects in the future. The successful candidate will have prior experience with human clinical research studies with face-to-face participant interaction. And the successful candidate will, ideally, have experience or familiarity with clinical research trials. The Hepatology Section has made a commitment to maintain a high level of awareness and compliance with the highest standards of practice and with regulatory issues impacting research, clinical care and education. This position will ensure that the Section not only complies with these regulations and policies, but sets the standard of excellence in this area. This position will maintain an awareness of, and familiarity with, policies and procedures impacting the liability and responsibilities of the Hepatology Section and The Division of Gastroenterology as it pertains to research, clinical care and education. **DUTIES AND RESPONSIBILITIES** Research Subject Management - 45% -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 – 20%: -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 - 15% -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 - 15% -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 – 5% **MINIMUM REQUIREMENTS** • Bachelor’s Degree in Social Sciences or other related field • At least 2 years of research coordination in hospital/ clinical setting _Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration._ **DESIRED QUALIFICATIONS** • 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 **WORKING ENVIRONMENTAL CONIDIATIONS** This is a full-time position that may require work outside of standard operating hours to meet programmatic deadlines. Due to the nature of some studies availability on nights and weekends will be requested. In the case this does occur comp time will granted for hours worked. Other: This position requires the ability to function independently, establishing priorities as needed with autonomy while reporting to the Hepatology Section Chief, and Center Research Manager. This position requires flexibility in number of hours and days, based on the needs of the job and associated stringent timelines with each project, occasionally working into the evening or weekends. Ability required managing work at multiple different campuses, in a virtual office environment Effectively work in varied clinical recruitment environment including: clinic, peri-procedure areas, hospital wards and ICU; Works effectively with multiple clinical investigators when needed; As part of the Administrative Team, and in support of the Division’s mission and goals, this position is expected to: • Share knowledge, information and expertise freely • Be flexible and responsive • Be reliable, supportive and positive • Communicate in a timely and effective manner • Communicate and behave in a respectful, open and direct manner • Perform as a team, assisting each other when appropriate • Cross train, when appropriate, in order to support each other in areas outside your own • Be open to new ways of accomplishing team goals • Problem solve in a positive manner and be open to learning from others • Seek input and listen to peers and colleagues • Think and work across boundaries • Take active responsibility for achieving team goals • Work to build effective teamwork and communications • Attend all meetings and actively participate in them • Participate in training sessions and team activities as necessary **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 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 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. \#UWDeptMedicineJobs University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.