Salary is commensurate with education and experience
As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our Benefits page.
The University of Washington (UW) is proud to be one of the nation's premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research, and community service. Our staff not only enjoys outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement, artistic pursuits, and natural beauty.
The University of Washington Alzheimer's Disease Research Center (ADRC) currently has an outstanding opportunity for an experienced RESEARCH COORDINATOR to coordinate and manage its clinical trials program and serve as the primary coordinator for the ADRC's Clinical Core. The UW ADRC is one of 31 Alzheimer's Disease Centers across the United States with funding from the National Institute on Aging (NIA). During the current five-year funding cycle, the UW ADRC's mission is to advance precision medicine for the molecular and clinical complexity of Alzheimer's disease (AD). The UW ADRC will advance research in genetic risk, develop neuroimaging and biomarkers for pre-clinical detection, discover novel therapeutics tailored to an individual's molecular drivers of disease and facilitate interventional trials in subjects with or at risk for developing AD.
The Research Coordinator (RC) will have primary responsibility for managing research programs surrounding Alzheimer's disease, playing an integral role in initiating, coordinating, organizing, and mantaining interventional trials. The RC will be responsible for developing statements of work (SOWs) including guidance on research study design in coordination with the principal investigator (PI), protocol development, reporting, data management, and personnel management. The RC will manage a $1.5 M interventional pharmaceutical trial for Alzheimer's disease under the supervision of study PI, as well as manage and supervise UW ADRC clinical core research staff. The RC will work with the PI's budget manager to produce project budgets for review and approval by the PI.
The RC will be directly involved in making recommendations and study design decisions that impact ADRC operations. As such, the RC will interact with a variety of populations, inlcuding faculty investigators, Center staff, clinical research subjects with varying levels of cognitive ability, family members of clinical research subjects, and associated external organizations, including Academic Medical Centers. The RC will direct and coordinate the flow of highly sensitive patient information and research data. The position will require the use of independent judgement, problem solving skills, project and time management, and delegated authority to ensure that each of the research projects remain on deadline for successful execution of benchmarked deliverables. The RC will assist (and lead, if applicable) in obtaining grant funding from internal and external agencies, including industry sponsors, that will directly impact the growth, sustainability, and ultimate success of the clinical trials program for the ADRC. Indeed, the position will require interaction with pharmaceutical trial sponsors, FDA, UW Medicine CRBB, UW IRB, OSP, and contracting departments within the UW and outside sponsors. The position will supervise operations of staff at the clinical research offices of the ADRC on the Harborview Medical Center (HMC) campus Ninth and Jefferson Building.
This position will impact the ADRC by directing the workflow of clinical trials from inception and design to billing and implementation. The position will support and augment the on-going research being done at the UW ADRC. This position will be pivotal in the introduction of phase III clinical trials in AD and related dementias to the HMC Clinical Core site. Indeed, the position's reach will result in increased visibility of the ADRC and University of Washington as a whole through exposure to and interactions with industry sponsors and national Alzheimer's Disease Centers (ADC).
This position supports the University's vision and mission by coordinating research studies of internal investigators with outside funding agencies to introduce phase III clinical trials for AD, contributing to the knowledge gained from each study, and facilitating the belief that discovery is at the heart of the University.
Research Project Administration and Management: (95%)
Oversee and/or conduct a broad range of research activities associated with each research project including recruitment, screening, consenting, administering neuropsychological testing, and specimen processing.
Independently develop and implement research project procedures that meet research objectives and ensure compliance with all aspects of Institution, Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA).
Design, develop, document and maintain policies and procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice (GCP) guidelines.
Manage budgets, develop new budget for ongoing ammendments and new trials, trial startup. Interface with CRBB and sponsors for budget management.
Design, create and revise research instruments (e.g. case report forms) as necessary to ensure quality data that satisfies research objectives.
Supervise and manage team of study research study coordinators and research assistants, including overseeing screening/treatment visits between clinicians, neuropsychologist, nursing and other staff.
Oversee training, performance monitoring, and supervision of research staff, including providing major input to staffing of overall project teams and building team and staff to optimize efficiency and meet deadlines.
Design, document and implement procedures for audits and site monitor visits to assure protocol compliance and to ensure research data quality.
Ensure that projects are executed successfully and completed within required time frames to meet research objectives.
Assist principal investigator by planning and conducting protocol of medical team research.
Manage clinical trial vendors and ensure queries and reports are resolved or completed in a timely manner.
Implement research protocols at HMC and UWMC, integrating research and clinical requirements to ensure patient safety and protocol compliance.
Manage data collection across multiple UW sites, liaising with ADRC and the Memory Brain Wellness Clinic at HMC.
Monitor data quality control to ensure adherence to study protocol.
Coordinate execution of and monitor project deliverables as dictated by established timeline, including recruitment and enrollment targets.
Prepare updates to director of program operations on each project's progress.
Interpret and apply study protocols.
Assess current clinical or administrative operations within sites to identify and establish successful workflow for research subject recruitment.
Perform initial and on-going needs assessments for optimal site participation and subject recruitment.
Participate in refining and updating research designs and assembling data collection in coordination with principal investigator to ensure timely delivery of results.
Perform related duties as required (5%)
Liaise with principal investigator (PI) and director of program operations to lead Clinical Core research team, including two research staff, research nurse, and physician assistant
Serve as primary point of contact for all ADRC Clinical Core questions and inquiries
Interface with internal and external partners to facilitate day-to-day operations of clinical trials and Clinical Core
Responsible for training, performance monitoring, and supervision of research staff, including research study coordinator 1 and research coordinator;
Provide major input to staffing of overall project teams;
Build team and staff to optimize efficiency and meet deadlines
4-5 years experience
Experience with interventional clinial trials
Project management experience
Familiarity with requirements of a clinical research environment and/or data entry
Excellent written and verbal communication skills;
Experience with Microsoft Office;
Experience managing and directing team;
This position will work with clinical research involving human subjects within UW Medicine and therefore clinical Research Study Coordinator (RSC) training is required. The training will include UW Medicine-specific as well as general training.
Experience with Medidata Rave or other clinical trial database platforms
Experience with pharmaceutical trials
Experience with database management, including REDCap.
Individual workspace in office shared with Director of Clinical Education containing desk, chair, telephone, shelving, file cabinets, and AMC-net workstation.
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 Work Authorization, Criminal Conviction History, 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.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergra...duate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.