Details
Posted: 20-Jan-23
Location: Seattle, Washington
Type: Full Time
Salary: Open
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 Neurology Department has an outstanding opportunity for a Research Coordinator to join their team.
The Department of Neurology at the University of Washington is proud of its tradition as a leading academic center dedicated to excellence in patient care, education, and research. We offer comprehensive consultation, evaluation and treatment services for adults and children with neurological disorders. Clinical facilities include the University of Washington Medical Center, Harborview Medical Center, Northwest Hospital, VA Puget Sound Health Care System and Seattle Children’s Hospital. Through our focus on research, we continue to gain insights into the functions of the human nervous system in health and disease.
POSITION PURPOSE This position requires knowledge of protocol requirements and good clinical practice as set forth by federal regulations. The Research Coordinator will manage the study operations and facilitate the daily research activities for research studies of participants with neuro-genetic conditions. Studies may include both observational and treatment studies, and may be funded by industry, foundations, and/or federal agencies. This position will be responsible for the enrollment and follow up of study subjects, completion of all data and source documentation, and adverse event reporting. This individual will assist with IRB submissions, the maintenance of regulatory files, developing a study budget in conjunction with the CRBB and tracking study reimbursements and other contract and budget requirements.
DUTIES AND RESPONSIBILITIES This position must be able to work independently on multiple research projects without the benefit of written policies or procedures. The position requires interaction with pharmaceutical sponsors, physicians, other health care personnel (e.g., nurses, patient care coordinators), and patients with varying levels of cognitive ability.
Protocol Management (45%) • Independently develop and implement research project procedures that meet research objectives and ensure compliance with all aspects of Institutional, Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research with human subjects (e.g., investigator financial disclosure requirements of the FDA).
• Design, develop, document, and maintain policies and procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.
• Design, create and revise research instruments (e.g., case report forms) as necessary to ensure quality data that satisfies research objectives.
• Design, document and implement procedures for audits to assure protocol compliance and to ensure research data quality. Develop and implement corrective action plans to ensure protocol adherence and data integrity.
• Ensure that projects are executed successfully and completed within required time frames to meet research objectives.
• Prepare for and participate in external study monitoring visits
• Prepare and submit IRB documentation for new application, modification, status reports
• other duties as necessary.
Study Subject Coordination (30%) • Coordinate and schedule participant appointments, ordering tests and procedures to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection.
• Meet and correspond with study patients, families, and physicians to determine eligibility for studies and provide information on the research studies.
• Ensure prompt and accurate data collection and entry.
• Consult with investigators on appropriate management of participant problems and concerns.
• other duties as necessary
Specimen Processing (15%) • Oversee and conduct specimen processing activities for research studies.
• Develop and manage study protocols for the Research Lab including Standard Operating Procedures (SOPs) for specimen collection, processing (blood, urine, stool, saliva, respiratory sample, including Covid-19 specimens), storage and/or shipping according to biohazard standards.
• Supervise and/or conduct specimen processing including centrifuging and aliquoting of samples, tracking, storage, and shipment in compliance with lab safety protocols. Minimally process blood and other samples as needed.
• Prepare specimens for laboratory analysis in accordance with study protocols- label, catalog, transport, and store laboratory samples
• Direct training and supervision of research staff.
Project Management (10%) • Work with collaborators and investigators and their institutions and with multiple UW departments (e.g., Office of Sponsored Programs, Human Subjects Division, Grant and Contract Accounting, Clinical Research Budgets and Billing) to insure timely and correct implementation, administration, progress and completion of research projects.
• Ensure compliance of research projects with all aspects of NIH, State of Washington and UW regulations pertaining to human subjects.
• other duties as necessary
MINIMUM REQUIREMENTS • Bachelor's degree in life sciences or health-related field
• 2-3 Years experience Research Coordination Experience
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
DESIRED QUALIFICATIONS • Ability to work with challenging patient populations
• Ability to work independently
• Ability to multitask
• Strong organizational skills and attention to detail
• Ability to work as a collaborative, cooperative, and congenial member of a close knit scholarly and admisitrative team
• Prior experience handling, processing, and transporting human biologic specimens
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 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. |