Req #: 242590 Department: NEUROLOGY Appointing Department Web Address: https://neurology.uw.edu/ Posting Date: 01/16/2025 Closing Info: Open Until Filled Salary: $4,736 - $10,031 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 an ongoing portfolio of clinical trials within the Memory and Brain Wellness 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 to the funding agencies and serve as liaison to the funding agencies and perform other related duties as needed. Under the supervision of the Program Manager and Principal Investigators, the incumbent will follow research protocols to obtain data through interviewing subjects/patients, conducting laboratory tests, consulting with the physician and reviewing medical records, coordinate patient participation in medical research studies and compile and verify the accuracy of research data. **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 faculty 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 and/or Advarra, work with CRBB for study start-up and ongoing study conduct, conduct submissions to Advarra, submissions to DSMBs, development and maintenance of SOPs for study specific 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 venipuncture, LPs, PET imaging, MRI, and operation of electronic monitoring equipment, processing of laboratory specimens, administering of treatment and/or medication in accordance with research protocol, assessment of patient reaction to medications and/or treatments as part of a research protocol and identification of potential adverse reactions. + Perform certain non-invasive patient 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. + Review medical records. + Keep study files in compliance with Food and Drug Administration's regulations. + Read, interpret, and communicate protocol for clinical studies providing data on the safety and efficacy of new drugs. + Establish and maintain effective working relationships with patients and their families, professional or community groups and volunteers. + Maintain contact with public agencies which are involved with aspects of the research of general public health care. + Communicate with the Departmental Administrator (when assigned) regarding the clinical trials including work flow, 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 patient safety. This position will work with minimal supervision and must use sound judgment to assess prioritization of all regulatory affairs to ensure timely submissions to regulatory bodies (IRB, UW CTMS, 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 + Develop and implement procedures and policies to carry out study specific clinical research involving human subjects including data collection methods and strategies for data management. + Screen, recruit, and interview potential subjects to determine eligibility according to specific study protocols. + Obtain informed consent. + Enroll patients in research protocol. + Explain research protocol to participants. + Respond to patient inquiries regarding protocol. + Schedule patient participation. + Coordinate all aspects of the patient's care. + Ensure compliance with research protocol. + Inform referring physicians of protocol requirements.Research Data and Publication Management + Maintain records and computer databases of study data. + Design/implement data collection tools. + Obtain and record research data in conjunction with PI and other professionals on the research team. + Manage electronic transfer of data. + Prepare interim reports for Principal Investigators, 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).Research Finance Management + Facilitate the application process (Grants and Contracts, IRB, Sponsor) to ensure timely implementation of research projects; help develop and monitor budgets. **Additional duties 5% as needed** **MINIMUM REQUIREMENTS** + Bachelor's degree in health management, biology, nursing, psychology or related field + 2 to 3 years minimum work experience and/or equivalent 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 or familiarity with data entry into databases. + Strong attention to detail and ability to multi task, 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 study approval process. + Experience communicating with industry sponsors regarding terms of agreement. **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.