Research - Laboratory/Non-Laboratory, Staff/Administrative
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 six consecutive years.
The Division of Cardiology is a large, complex Division in the Department of Medicine with over 100 faculty, 31 fellows and over 100 professional, classified and hourly employees spread across 6 campuses: UW, Harborview Medical Center, Northwest Hospital, Edmonds Cardiology Clinic, VA Puget Sound Hospital and UW South Lake Union. The Division of Cardiology physicians address the prevention and treatment of heart and vascular disease through the investigation of new technologies, drugs, and devices that ultimately translate into best practices and improvement of patient care.
The Division of Cardiology has an outstanding opportunity for a full-time Regulatory Research Coordinator. The Clinical Trials Unit (CTU) at the University of Washington supports investigators by providing a sound clinical research infrastructure and ensuring research participant safety, compliance with federal, state and institutional regulations, policies, and procedures. The CTU provides investigator support on all aspects of heart and vascular disease for investigator initiated, government, and industry sponsored clinical research studies. The CTU supports and manages Human Subjects, regulatory, and financial oversight to ensure efficient execution of studies with the highest quality data.
Position Dimensions and Impact to the University:
This position requires an in-depth knowledge of protocol requirements, good clinical practices as set forth by federal regulations, and financial management. As the primary expert for clinical research regulations, the Regulatory Research Coordinator will facilitate the implementation and post award maintenance of clinical trials. This individual will assist with IRB submissions, the maintenance of regulatory files, development of study budgets in conjunction with the CRBB, tracking study reimbursements, and other contract and budget requirements as set forth my OSP and UW Compliance.
Duties & Responsibilities:
The major duties can be categorized in 3 major areas: study project management, communications management, and other duties as required.
Study Project Management
Manage pre and post award processing of clinical trials such as budget creation and negotiation, and submission of trials to institutional bodies (CRBB, OSP, HSD, Compliance) for approval.
Build and maintain study trackers for trial revenue and cost tracking, review hospital patient billing, oversight of study faculty and staff salary allocations, and processing of trial amendments.
Assist with overseeing the creation, management, accuracy and completion of all regulatory documents, IRB documents, and signed informed consent forms.
Facilitate and manage all activities related to study Site Qualification and Site Activation visits and ensure all required documentation is available to Industry partners.
This position also involves the development of grants and their supportive budgets.
Effective and timely communication with Industry, NIH and IRB project offices, and clinical sites (UWMC, HMC) is an essential part of this position.
The Regulatory Research Coordinator must have a good working knowledge of each protocol and federal regulations in order to address and handle issues from the project offices.
The Regulatory Research Coordinator will have daily written and verbal communication with Cardiology research faculty, fellows, work study students, Division of Cardiology grants and contracts office, CTU staff, CRBB, OSP and sponsors.
In conjunction with the Lead Regulatory Research Coordinator this position will serve as the primary point of contact and knowledgebase for trial activation.
Along with the Lead Regulatory Research Coordinator and Research Manager this person will work on the implementation of a trial protocols presented to the Division of Cardiology Clinical Trials Unit.
This person will be required to perform study implementation duties including obtaining study regulatory documents, and protocol assessment pricing. Undergo required Human Subjects Training and Good Clinical Practice (GCP) training.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Bachelor's degree in a related field and at least 2 years of research experience.
Excellent communication, organizational, and critical thinking skills
Experience with Microsoft Office 2007, the Internet
Advance knowledge of Microsoft Excel: Smartsheets, Pivot Tables, Template and report building
Knowledge of IRB application processes, and FDA regulations
Ability to read and evaluate clinical research protocols
Previous clinical research experience
Basic math and budgeting skills
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Previous experience working with UW Clinical Research Budgeting and Billing (CRBB) group as well as UW Office of Sponsored Programs (OSP) on study implementation.
Working understanding of IRB approval process.
Previous project management experience.
Experience working with/working knowledge of Cardiovascular diseases.
CONDITIONS OF EMPLOYMENT
The ability to have a flexible work schedule, both in the number of hours and days as required by workload.
Ability to travel for trainings and investigator meetings as necessary
Ability to work in a fast paced high demand environment
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.
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 undergraduate 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.