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University of Washington CLINICAL TRIALS PROGRAM MANAGER in Seattle, Washington

Req #: 199711

Department: NEUROLOGY

Posting Date: 11/23/2021

Closing Info: Open Until Filled

Salary: Salary is commensurate with education and experience

Shift: First Shift

Notes: As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academi-staff-20210208.pdf)

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. UW has an outstanding opportunity for a Clinical Trials Program Manager! RESPONSIBILITIES Program Management (30%) -Manage the operations of the MBWC Clinical Trials Program which includes: -Create and negotiate study budgets with sponsors -Work with institutional authorities (e.g. Office of Sponsored Programs and IRBs) for study start up, amendments, and renewals -Organize, attend, and act as key point person for Clinical trial site initiation visits -Develop quality assurance measures/methods, develop SOPs for center processes -Oversee implementation of research protocols, study close-out process, record retention and regulatory and compliance requirements -Assist with data QA/QC in internal databases and to sponsors -Track and run data analytics and metrics for continual internal process improvements -Oversee the completeness of Clinical Trials documentation -Work with clinical trial sponsors’ delegated monitors to oversee compliance during regular study monitoring visits -Review resource use proactively and periodically in the Clinical Trials Program and Clinical Core (e.g. staff delegation, room use, supplies & equipment); identify and anticipate bottlenecks; and prepare plans to address identified issues -Oversee ADRC and MBWC Clinical Trials equipment, supplies, and clinic spaces to monitor appropriate certifications, trainings, and utilizations -Review and optimize the system for Clinical Core visits for improved efficiency -Review and optimize Clinical Core and trial visit procedures to remove barriers and ensure equity for participants of different SES statuses, racial and/or ethnic backgrounds, and physical abilities -Ensure regular communication with the faculty leads of the Clinical Trials Program; escalate issues to faculty as appropriate Fiscal Management (20%) -Negotiate trial contracts with sponsors -Work in collaboration with UW fiscal teams to develop Clinical Trial budgets -Be point person for CRO contacts -Work in collaboration with UW fiscal teams to ensure quarterly invoices to sponsors are complete, accurate, and timely -Monitor study subject stipends and reimbursements Staff management (20%) -Directly manage, supervise, and direct MBWC Clinical Trials Program Research Coordinators -Direct Clinical Core Research Coordinators in aspects related to integrating workflow across Clinical Core and Clinical Trials -Oversight and direction of the trials and Clinical Core staff cross-training to ensure adequate training for back-up for Clinical Trials and Clinical Core visits -Onboarding and training of new Clinical Core and Clinical Trials staff, monitoring of annual training and certification requirements Recruitment of study participants (15%) -Work with ADRC faculty in the strategic development for enrollment targets in Clinical Trials Program and Clinical Core -Assist in the recruitment of traditionally under-represented groups in ADRD research -Collaborate with the ADRC recruiter to optimize recruitment to Clinical Core and Clinical Trials; manage cross-recruitment between studies -Oversee the pipeline of enrollment from the REDCap potential participant directory/registry to enrollment into the Clinical Core and Clinical Trials Program -Attend outreach events when appropriate Conduct study visits (5%) -Be trained and cover as a CDR rater for study visits when the need arises -Conduct study visits as the needs arise Other (10%) -Other duties as they arise MINIMUM REQUIREMENTS: Bachelor's degree in business, social sciences, science or other related field and 4-5 years of experience ADDITIONAL REQUIREMENTS: • Experience overseeing a large portfolio of clinical trials, ideally in Alzheimer's disease or a related field • Experience in managing regulatory and budgetary elements of clinical trials • Scientific expertise in ADRD or extensive experience working in a multi-disciplinary environment focused on ADRD research • Experience working with diverse research participants • Previous experience in outreach to, or recruitment of, people from communities who are traditionally under-represented in ADRD research • Experience supervising, managing and directing staff members • Ability to take initiative and work independently to develop workflow solutions • Experienced in using remote meeting platforms (Zoom, Teams, etc), internet, and email • Proficient in Word, Excel, Powerpoint, and similar • Excellent interpersonal skills • Excellent verbal and written communication • Ability to multi-task and prioritize in a fast-paced environment • Attention to detail and excellent organization skills • Ability to work with many different stakeholders in a consistently positive and productive manner • Sensitivity to diverse cultures and backgrounds of research participants DESIRED: • An advanced degree (e.g. Master's, PhD) in a relevant field such as neurology, neuropsychology, gerontology, population health, epidemiology, health disparities research, genetics, 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.

University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.

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