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. All of which has allowed the UW to be nationally recognized as a "Great College to Work For" for five consecutive years. The Kidney Research Institute (KRI) functions as the research arm within the Nephrology Division of the UW Department 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.The Division of Nephrology in the Department of Medicine has an outstanding opportunity for a full-time Project Manager. The Project Manager (PM) will 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 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. Study management/management of multiple data collection efforts, consistent development of best practices and stay on track with research milestonesCoordinates multiple data collection efforts for one or more research projects which may include other collaborating agencies or institutionsCoordinate/oversee transmission of samples and data between collaborators/institutionsDevelop 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 mattersEnsure 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 requirementsManaging 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 groupsTeam coordination with KRI managers and other study site personnel for multi-site studies, coordinate calls/meetings related to studiesDevelop 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 systemsAuthoring 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 submissionsManuscript submission, tables, references, formatting figuresAbstract 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 analysisAssist 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 dataRegulatoryRegulatory and compliance supportEnsure compliance with IRB requirementsAdverse events collection/reporting for reporting to IRB, FDA, other fed agencies, sponsors, clinical trials.govMaintain 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.REQUIREMENTS: Bachelor's Degree in Public Health, Biological/Social Sciences, Social Work or related fields and one year of relevant experience.Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.DESIREDMPH, MS Epi, or related graduate degreeTwo to three years of relevant work experienceStrong interpersonal skills and flexibility to work with personnel at various levels in a cross-institutional research environmentDemonstrated ability to lead the implementation of complex research protocols and maintain high standards of accuracy, timeliness and professionalismDemonstrated 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 benchmarksExperience demonstrating a high degree of organizational skills with a high degree of attention to detailsReliability and flexibility to work independently and function as a lead in directing the work of a diverse teamPrior 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 researchStrong verbal and written communication skillsBasic biostatistical and epidemiological principles/methods, STATA or similar statistical softwareCertified Research Coordinator (CCRC), Association of Clinical Research ProfessionalsResearch Electronic Data Capture (Redcap) and Bio-repository database experience preferredFamiliarity and experience with kidney disease and related illnessesCONDITIONS OF EMPLOYMENT Flexibility to work a variable schedule as neededAbility to commute for local travelApplication 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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