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The Kidney Research Institute (KRI) and Kidney Precision Medicine Project (KPMP) have an excellent opportunity for a Project Manager (PM) to provide professional level lead support for multi-funded and multi-site clinical research studies involving human subjects with kidney disease and related conditions. This position entails working directly with KRI and KPMP investigators on a wide range of scientific research projects related to kidney disease. The PM will provide professional level coordination for multi-funded and multi-site clinical research studies involving patients with kidney disease. The PM will participate in developing research designs, data collection methods and strategies for data management. Additionally, the PM will manage multiple data collection efforts which will include other collaborating agencies and institutions nationally and internationally. The PM will write and edit reports, develop and monitor reports and work with funding agencies, and train/direct the work of assigned staff in related areas as needed.
The Kidney Research Institute (KRI) functions as the research arm within the Nephrology Division of the UW Deprtment of Medicine with a goal of conducting innovative clinical research to improve the health and quality of life of persons with renal disease and related conditions. The Kidney Precision Medicine Project (KPMP) Central Hub is a large study conducted by the KRI, with an objective to create an environment to promote scientific rigor, patient safety, and the successful interdisciplinary team science necessary to result in major advances in kidney disease research. The Project Manager will have a vital role in the progression of research both at KRI and KPMP.
Specific duties include:
Study management/management of multiple data collection efforts, consistent development of best practices and stay on track with research milestones
Coordinate multiple data collection efforts for one or more research projects which may include other collaborating agencies or institutions
Coordinate/oversee transmission of samples and data between collaborators/institutions
Develop and assist with annual reports, center reports, grant submission components, JIT materials for principal investigators, industry sponsors and institutional review board to ensure that each project is moving toward timely completion.
Use statistical and database management programs to analyze data and prepare summary narrative reports, graphs, tables, charts and illustrations;
Liaison between the project team and funding agencies or significant parties. Liaison for complex regulatory or compliance matters
Ensure that projects are executed successfully and completed within time frames to meet research objectives.
Implement investigative research protocols and monitor adherence to protocol; troubleshoot and resolve problems such as deviation from protocol requirements
Managing work flows, ensuring high quality standards are adhered to, training/supervision as needed
Presenting research results, study objectives or goals in publishable form, and/or presenting to various stakeholder groups
Team coordination with KRI managers and other study site personnel for multi-site studies, coordinate calls/meetings related to studies
Develop research designs, data collection methods and strategies for data management
Design/write case report forms – promote consistent data capture and successful statistical analysis; develop research protocols and procedures; develop data dictionaries, merge data sets
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.
Preparation/refinement/updates to study protocols, MOPs, study materials (patient report forms), handouts, communication materials
Generate figures and tables for papers, presentations and grants submissions
Abstract technical or medical data from medical records. Enter data from research data collection instruments into computer database; assist with data management functions; assist in data analysis
Assist in the preparation of human subject applications, consent forms, and modifications in compliance with Institutional Review Board (IRB) requirements;
Maintain adherence to research protocols and verify accuracy of research study data
Regulatory and compliance support
Ensure compliance with IRB requirements
Adverse events collection/reporting for reporting to IRB, FDA, other fed agencies, sponsors, clinical trials.gov
Maintain copies of regulatory documents (IRB and VA R&D) and personnel training verifications and other certifications. Ensure compliance with regulations.
Audit preparation and facilitation (internal or sponsor initiated)
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, social work, or related field and at least two years of related experience or equivalent combination of education and experience.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
MPH, MS, or related graduate degree Two to three years of relevant experience
Strong interpersonal skills and flexibility to work with personnel at various levels in a cross-institutional research environment
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
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, VA and HMC setting.
Strong verbal and written communication skills
Ability to commute between various sites: UWMC, NKC, HMC, etc
Basic biostatistical and epidemiological principles/methods, STATA or similar statistical software Certified Research Coordinator (CCRC), Association of Clinical Research Professionals
Research Electronic Data Capture (Redcap) and Bio-repository database experience preferred
Familiarity and experience with kidney disease and related illnesses
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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