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The Collaborative Health Studies Coordinating Center (CHSCC) in the Department of Biostatistics is seeking a full-time Clinical Operations Manager to join our collaborative research team. The CHSCC coordinates several large-scale NIH funded cohort studies, primarily in the areas of cardiovascular epidemiology and nephrology, and enjoys an excellent reputation for research design and biostatistical analysis. This position is primarily with the Kidney Precision Medicine Project (KPMP), an NIDDK funded study of participants with kidney disease. Under the direction of the Project Director, the Clinical and Data Operations Manager will be responsible for developing and maintaining study documentation, will be the primary liaison with clinical sites for all clinical operations issues, will be responsible for reporting site status, and will be responsible for reviewing, cleaning, and querying sites re: study data.
This position is best suited to an individual who is not only very accomplished in data and analysis but also brings exceptional operational and organizational skills across many aspects of clinical operations. Being point of contact for a large number of field centers adds additional skills in communication, responsiveness, and juggling multiple and competing priorities.
The KPMP project is a high profile and important project for UW, and this COVID project contributes to public health in an important way during the pandemic.
Duties & Responsibilities:
Triage problems/questions from clinics – forward issues to other staff when necessary. Main contact at Data Coordinating Center for all protocol and clinical operations questions, as well as software questions
Ensure Data Coordinating Center and clinic compliance with all regulations, including proper consent forms and IRB approvals
Develop and maintain all data collection forms and manuals of operations in conjunction with Project Director(s) and Principal Investigators
Assist with conducting regular field center staff conference calls. Develop material to present during these calls. Participate in standing study committees, including assistance with scheduling and minutes.
Collaborate with programming staff on software updates, testing, and bug-corrections
Coordinate, set-up and conduct training of field center personnel, includes central training and any re-training necessary during data collection
Collaborate with Principal Investigators on clinical procedures for laboratory specimen collection and communication with laboratories
Assist the Project Director in design of quality assurance systems and on-line reports
Track certification and certification maintenance of clinical personnel. Follow-up with Field Center staff as needed
Coordinate and conduct evaluation of clinical performance and adherence to protocol during clinical site visits (as necessary)
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Master’s Degree in Public Health, Epidemiology, or related field.
Minimum 2 years managing clinical operations in a research setting.
Experience may substitute for degree.
Understanding of operations for a human-subjects research clinic
Excellent oral and written communication skills. Able to work with a variety of personnel (administrative, support, investigators, etc)
Organized and attentive to detail
Familiarity with Human Subjects/IRB/HIPAA issues and procedures. **Willingness to travel for purposes of site training and/or study meetings
Equivalent education/experience will substitute for all minimum qualifications except where there are legal requirements such as license/certification/registration.
Experience working in a clinical research center -
Previous experience in the administration and coordination of a large epidemiological cohort study
Familiarity with using REDCap to design, conduct, and/or monitor data collection
Experience using project management software to track and report on complex projects, such as Smartsheet, Trello, Access, Microsoft Teams, etc
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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