Research - Laboratory/Non-Laboratory, Staff/Administrative
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The Department of Neurology offers comprehensive consultation, evaluation and treatment services for adults and children with neurological disorders, through its clinical facilities at the University of Washington Medical Center, Harborview Medical Center, Northwest Hospital and Medical Center, VA Puget Sound Health Care System and Seattle Children's Hospital and Regional Medical Center. Through our commitment to research, we continue to gain insight and understanding into the normal and abnormal functions of the human nervous system and how to care for related disorders. We are then able to share the knowledge gained and results of this research with our colleagues at the University, across the nation, and around the world. The Neurology Clerkship and Residency Training Programs represent significant foci of the Department's efforts. We are extremely proud of our programs, which regularly receives applications for training from around the world. Clinical exposure is outstanding, teaching is a top priority, research and collaborative opportunities are abundant, and our faculty are friendly and approachable.
The Department of Neurology has been a center of clinical and academic excellence since 1995, and has a mission that includes meeting the health-care needs of patients with neurological issues, advancing knowledge through research in the clinical and basic neurosciences and training the next generation of neurologists in our residency program through its clinical facilities at the University of Washington Medical Center, Harborview Medical Center, VA Puget Sound Health Care System and Children’s Hospital and Regional Medical Center.
The Department of Neurology has an outstanding opportunity for a full time Grade 7 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 40%:
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 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 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 30%:
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 20%:
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 5%:
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: 5%
REQUIRED QUALIFICATIONS: Bachelor's degree in related field including but not limited to health management, science, nursing, psychology and 2 to 3 years minimum work experience and/or equivalent work experience.
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
Experience with the UW grant approval process.
Experience communicating with industry sponsors regarding terms of agreement.
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 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.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.