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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 budgeting and 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 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. The individual in this position will also take part in the call schedule for clinical trials of neurology.
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 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. • 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 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 regarding the entire portfolio of 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 patient safety. This position may work with minimal supervision and must use sound judgment to assess prioritization of all regulatory affairs 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: • Develop and implement procedures and policies to carry out clinical research studies 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 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, 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 grant application process (Grants and Contracts, IRB, Sponsor) to ensure timely implementation of research projects. • Develop and monitor budgets, develop computerized tracking and database management systems.
Other Duties as Assigned.
MINIMUM REQUIREMENTS •Bachelor's degree in health management, biology, nursing, psychology or other related field. Equivalent experience can substitute degree requirement. •1 year or less work experience.
Additional requirements: •Proficient in Microsoft Office applications. •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.
Equivalent education and/or experience may substitute for minimum requirements.
DESIRED REQUIREMENTS •Experience with the UW grant approval process. •Experience communicating with industry sponsors regarding terms of agreement. •Experience with clinical trials. •Willing to learn/ability to work with data entry into databases. •Previous experience conducting research in a hospital or academic setting. •Previous regulatory affairs or research coordination experience. •Experience with phlebotomy. •Experience processing biological samples.
CONDITIONS OF EMPLOYMENT 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 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 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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