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The Kidney Research Institute (KRI) has an excellent opportunity for a Research Coordinator to provide lead support for multi-funded and multi-site clinical research studies involving human subjects with kidney disease and related conditions. The KRI functions as the research arm within the Division of Nephrology in the University of Washington Department of Medicine. Its goal is to conduct innovative clinical research to improve the health and quality of people with kidney disease and related conditions.
Under the general supervision of the Principal Investigator, the Research Coordinator will be responsible for research studies involving subjects with Kidney Disease. This position will also be responsible for defining and designing research protocols for the research team. The Research Coordinator position requires knowledge of FDA, IRB, and local regulations related to the conduct of research studies. This position entails working directly with KRI investigators on a wide range of scientific projects related to kidney disease.
Specific duties include:
Study coordination of multiple data collection efforts
Integrate information from multiple sources to ensure that research proposals meet the necessary requirements of funding agencies.
Design, create and revise research instruments as necessary to ensure quality data that correlates with research objectives.
Coordinates multiple data collection efforts for one or more research projects which may include other collaborating agencies or institutions.
Consult with co-investigators on appropriate management of participant problems and concerns.
Develop and manage interim reports for principal investigators, industry sponsors and institutional review board to ensure that each project is moving toward timely completion.
Act as a liaison between the project team and funding agencies or significant parties.
Act as a liaison for complex regulatory or compliance matters
Ensure that projects are executed successfully and completed within time frames to meet research objectives.
Contribute to the analysis of research study results
Initiate and establish contact with external contacts, agencies, providers and/or study sponsors as dictated by the needs of the research study and in coordination with the PI and provide referral services to participants
Implement investigative research protocols and monitor adherence to protocol; troubleshoot and resolve problems such as deviation from protocol requirements
Abstract technical or medical data from medical records. Enter data from research data collection instruments into computer database; assist with data management functions;
Collect data in a variety of settings as dictated by research study; Audit preparation and facilitation (internal or sponsor initiated)
Presenting research results, study objectives or goals in publishable form, and/or presenting to various stakeholder groups
Implement research designs, data collection methods and develop strategies for data management
Complete case report forms – promote consistent data capture and successful statistical analysis
Adverse events collection/reporting for reporting to IRB, FDA, other fed agencies, sponsors, clinical trials.gov
Implement research protocols and procedures necessary to test the hypotheses of the research studies.
Develop forms, questionnaires, and clinic procedures for collecting and summarizing observations and data
Assist in development of procedures for the design of measurement instruments and scoring systems
Authoring technically detailed scientific documentation and study materials appropriate for a general audience and clinical/technical audience.
Actively participate in recruitment and oversight of human subjects/participants; specimen processing, storage, tracking
Develop plans for subject retention
Specimen processing as needed, storage, and tracking of specimens
Maintain contact with local health care providers.
Coordinate with KRI managers and other study site personnel for multi-site studies.
Interview, screen and recruit subjects based on specific inclusion and exclusion criteria to determine eligibility according to established study criteria;
Interact with human research subjects in achieving goals of our studies, answering subjects’ questions, and explaining research procedures and goals; administer tests and record observations
Assist in the preparation of human subject applications, consent forms, and modifications in compliance with Institutional Review Board (IRB) requirements;
Maintain copies of regulatory documents (IRB) and personnel training verifications and other certifications. Assure compliance with regulations.
Manage work flows, ensuring high quality standards are adhered to, training/supervision as needed
Scheduling of subjects and sending reminders of appointments. Monitoring of subjects to maintain adherence to protocol
Perform other duties such as preparing study binders, assisting with mailings and inter-office communications, and other related duties as required.
Overall training/supervision of research assistants, students, other research staff as needed.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Bachelor’s degree in public health biological sciences, social sciences, or related discipline and two years of related work experience.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Demonstrated ability to lead the implementation of complex research protocols and maintain high standards of accuracy, timeliness and professionalism
Demonstrated ability in ensuring security and confidentiality of study materials.
High level of competency, good judgment, discretion in carrying out tasks, troubleshooting problems and following through on projects to meet deadlines and study benchmarks
Proven experience demonstrating a high degree of organizational skills with a high degree of attention to details
Proven reliability and flexibility to work independently and function as a lead in directing the work of a diverse team
Strong interpersonal skills and flexibility to work with personnel at various levels in a cross institutional research environment
Familiarity and experience with kidney disease and related illnesses
Prior experience in a laboratory or clinical research environment to facilitate interactions between laboratory staff, research coordinators and research staff.
Thorough knowledge of HIPAA, IRB and related institutional requirements for the conduct of research. Experience working with the UW , NKC and Harborview Medical Center (HMC) setting.
Proficiency with MS Office Platform, particularly Access. Strong verbal and written communication skills
Ability to commute between various sites: UWMC, NKC, HMC, etc
Basic understanding of biostatistical and epidemiological principles/methods
Certified Research Coordinator (CCRC), Association of Clinical Research Professionals
Research Electronic Data Capture (Redcap) and Bio-repository database experience preferred
Clinical Research Coordinator training
CONDITIONS OF EMPLOYMENT
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 Workforce 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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