UNIVERSITY OF WASHINGTON ENDOCRINOLOGY RESEARCH COORDINATOR

RESEARCH COORDINATOR

Req #: 151734 Department: METABOLISM, ENDOCRINOLOGY AND NUTRITION Job Location: Other Location Posting Date: 12/13/2017  Closing Info: Open Until Filled  Salary: Salary is commensurate with experience and education  Shift: First Shift

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 four consecutive years.   The Division of Metabolism, Endocrinology and Nutrition includes approximately 44 faculty members with a variety of research interests in the areas of lipids and lipoproteins, diabetes  mellitus, nutrition and its related disorders, and reproductive endocrinology. The Division of Metabolism, Endocrinology and Nutrition is a sub-specialty unit within the Department of Medicine  and School of Medicine at the UW.  The Division of Metabolism, Endocrinology and Nutrition has an outstanding opportunity for a part-time (80% FTE) Research Coordinator.  This position will work closely with the study principle investigator(s), sub-investigator(s),  research coordinator(s), research assistants, and other study staff to ensure IRB protocol adherence,  sponsor adherence according to contractual obligations, and other applicable regulatory agencies. Other activities include, the development of procedures to meet research goals and collaboration in a fast-paced team-focused environment for the University of Washington and the Diabetes Care Center. This position reports to the study principle investigator and the Research Manager.  Position Dimensions and Impact to the university:  The Diabetes Care Center (DCC) is a multidisciplinary research center established by the Department of Medicine supporting research to improve the quality of diabetes care at the local, regional and national level.  Research is an integral part of the treatment equation, keeping faculty informed about new treatments, current research and future trends in health recommendations and treatment modalities. Maintaining an active clinical research base is key in providing physicians the opportunity to be  involved in improving patient care and learning of new treatments.  Having both diabetes research  and clinical care at DCC provides an enriched environment fostering excellence in patient care.  POSITION RESPONSIBILITIES  Research Patient Management  Recruit, screen, consent, enroll, and track study participants  Implement study protocols and recruit patients using appropriate recruitment tools  Oversee study participant visits and conduct study related procedures per protocol  Coordinate visits with other study staff and other active protocols  Retrieve study medications from UW Investigational Drug Services  Record all data related to intervention per PI  guidance and review  Provide referral services to participants  Access and enter data in EMRs including: Epic, Mindscape, and Cerner (ORCA)  Database Management Analysis and Reporting  Assist in development of study-specific database  Develop and maintain data quality control program  Analyze data to  create tables and other data visualization tools to maintain  study recruitment and study specific outcomes  Protocol Management and Responsibilities  Able to coordinate and manage multiple projects  Complete site selection surveys with the principle investigator and research manager  Work as the liaison between the sponsor, coordinating center, and the study site.  Assist in the formulation of study specific budgets and ensure study compliance with Clinical Research Budget and Billing office  Assist in developing ICFs, CRFs, surveys, and SOPs for collecting data  Create and maintain staff GCP binder  Maintain records for investigator, coordinator, and other study staff curricula vitae (CVs), NIH biosketches, abbreviated CVs, resumes, CITI GCP trainings, dry ice training, and dangerous goods training  Maintain staff certificates for study related EDCs and other applicable protocol trainings  Organize and facilitate all-study meetings for local staff, and sponsor representatives via conference calls, email correspondence, and by weekly meetings  Make supply purchases to ensure adequate stock of supplies for applicable studies and day to day staff activities  Prepare and manage IRB applications through study closeout  Prepare and submit payment requests to the fiscal manager and research manager for study visits which include extra visits, phone calls, and sub-study visits  Lead responsibilities: May direct Research Assistant activities and provide protocol specific and/or site training.  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 science or health related field plus a minimum of two to three years related experience.  Additional  Requirements:  Excellent organization, communication, and management skills (oral and written) are necessary to provide service – in person and on the phone – to research coordinators, office staff and research participants.  Must be able to work both independently and as a team member and to coordinate a working knowledge of Microsoft office programs: Word, Excel, OneNote, Outlook, and PowerPoint  Proven ability to coordinate multiple protocols including industry sponsored and NIH grant funded studies  Knowledgeable to develop Reliance Agreements with the University of Washington IRB  Experience exporting and analyzing data in electronic data capture systems; EPIC, Mindscape, Cerner (ORCA), T1D Exchange, Oracle, Inform, eSite Access, Imedidata, and My Study Portal  Expertise working with Diabetes Management systems: Dexcom Studios, Carelink, Tidepool, Oracle, My Glucohealth, Glucofacts, My Health Point, and Clinphone  Experience processing, packaging, and shipping lab specimens to labs: urine samples, HbA1c, blood serum extraction, etc.  Previous experience working with diabetes patients for both Type I and Type II diabetes  Previous experience in clinical research project coordination; knowledge of FDA 21 CFR 50, and HHS 45 CFR 46 regulations, HIPAA, ICH Guidelines, and Good Clinical Practice; as well as, experience in clinical trial development, implementation, and analysis.  Must have completed dry ice certification, Good Clinical Practices, Protecting Human Research Participants, EDC (electronic data capture) in the last year  An ability to prioritize, coordinate and perform multiple tasks in a fast-paced work environment  Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.  CONDITIONS OF EMPLOYMENT  Appointment to this position is contingent upon obtaining satisfactory results from a criminal background check.  Research does not always have consistent work hours.   When a clinical trial starts or completes,  an earlier start time or longer work hours may be required in order to meet protocol-required s chedules and deadlines.  Some studies require recruitment efforts such as health fairs, meetings with external institutions or being present for speaking engagements that occur evenings or weekends. There are also times when email must be checked early mornings, evenings or weekends outside  of normal work hours.  This is done during recruitment and scheduling, also to follow-up research participants who have medical issues.  Some clinical trials require research staff, including this position, to be ‘on call’ to answer  questions from research study patients who call or email.  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, 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. APPLY