Req #: 239210 Department: THE DEPARTMENT OF NEUROLOGY Posting Date: 09/27/2024 Closing Info: Closes On 10/11/2024 Salary: $4,054 - $7,500 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 Neurology has an outstanding opportunity for a Full-time RESEARCH COORDINATOR. This position is responsible for coordinating ongoing clinical trials within the Alzheimer's Disease Research Center. This includes project start-up such as regulatory activities, along with implementation of study protocol and close out actions, all while adhering to University and sponsor guidelines. In addition, the individual in this position will work with the Offices of Human Subjects, Compliance, Sponsored Projects and others as necessary to get all the required approvals prior to submission. The incumbent will also prepare reports and serve as liaison to the Sponsors as well as other related duties as needed. Under the supervision of the Program Manager, the incumbent will follow research protocols to obtain data through interviewing subjects/patients, conducting laboratory prep, consulting with the physician and reviewing medical records, coordinate subject participation in medical research studies and compile and verify the accuracy of research data. This position is essential to the clinical care mission of UW Medicine, in addition to compliance with UW Research policies and safeguarding protected health information (PHI). The Research Coordinator position requires full-time, on-site work, as this is a patient-facing role. **DUTIES AND RESPONSIBILITIES** Research Study Management + Serve as the point-person for tracking tasks and documents between UW and all collaborative sites (e.g. SOPs, enrollment, site challenges) and provide reports to leadership on a weekly basis. + 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, work with CTO for study start-up and ongoing study conduct, conduct submissions to IRB, and maintenance of SOPs for study protocols. + Ensure that projects are executed successfully and completed within needed timeframes to meet research objective. + Coordinate specialized tasks with the medical team such as:-Review medical records.-Perform certain non-invasive subject oriented procedures.-Responsible for the collection, processing and shipping of study-specific laboratory specimens.-Coordinate physician examinations and study protocol for technicians.-Assist in planning aspects of medical team research.-Administering of treatment and/or medication in accordance with research protocol-Assessment of subject reaction to medications and/or treatments as part of a research protocol-Identification of potential adverse reactions.-Keep study files in compliance with Food and Drug Administration's regulations.-Read and communicate protocol for clinical studies providing data on the safety and efficacy of new drugs.-Establish and maintain effective working relationships with subjects and their families, professional or community groups and volunteers. + Communicate with the Program Manager regarding the clinical trials including workflow, timelines, funding and other pertinent information. + Ensure research trials and projects meet regulatory requirements and are compliant with federal and institutional policies. This is critical for ensuring the quality of the research, the reputation of the institution, and subject safety. + This position will work with only some supervision and must use sound judgment to assess prioritization of all regulatory affairs documents to ensure timely submissions to regulatory bodies (IRB, FDA, sponsor, etc.). + Oversee, coordinate, and implement regulatory submissions to internal and external governing bodies. This includes new study applications, annual reviews, modifications to existing studies, serious adverse events, and protocol deviations.Patient/Participant Management + Implementation of procedures and policies to carry out clinical research studies involving human subjects including data collection methods. + Screen, recruit, and interview potential participants to determine eligibility according to specific study protocols. + Obtain informed consent. + Enroll subjects in research protocol. + Explain research protocol to subjects. + Respond to subject inquiries regarding protocol. + Schedule subject participation. + Coordinate all aspects of the subject's care. + Ensure compliance with research protocol. + Inform referring physicians of protocol requirements.Research Data Management + Maintain records and computer databases of study data. + Implement data collection tools. + Obtain and record research data in conjunction with physician and other professionals on the research team. + Manage electronic transfer of data. + Prepare interim reports for Principal Investigators, Program Manager, Study Sponsor and Human Subjects Review Board to ensure that each project timeline is being met. + Communicate with pharmaceutical and equipment company medical personnel in handling results of studies (progress reports, case report forms). + Other Duties as Assigned 10% **MINIMUM REQUIREMENTS** + Bachelor’s Degree in health management, biology, nursing, psychology or other related field.1-year minimum work experience. **Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.** **ADDITIONAL REQUIREMENTS** + Experience in research coordination and conduct of clinical trials. + Proficient in Microsoft Office applications. + Experience with UW Epic, REDCap, and data entry. + Experience with patient/caregiver medical interactions. + Strong attention to detail and ability to multitask, organize, and prioritize multiple projects. + Ability to work independently and in a group under limited direction. + Excellent verbal, written, interpersonal and communication skills. + Should be highly motivated and flexible, with the ability to adjust to rapidly changing priorities and new projects. **DESIRED QUALIFICATIONS** + Experience with the UW CTMS and clinical trials process. + Experience communicating with industry sponsors regarding study processes and monitoring. **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. 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.