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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 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 has an outstanding opportunity for a full-time Research Coordinator located at the UW Montlake Campus. This position requires an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary expert for the protocols, the Research Coordinator will manage the study operations and facilitate the daily research activities of the investigators with an emphasis on the enrollment and follow up of study subjects. In addition, the employee will manage completion of all data and source documentation and adverse event reporting. This individual will assist with IRB submissions, the maintenance of regulatory files, reviewing a study budget in conjunction with CRBB’s development, and tracking study reimbursements and other contract and budget requirements.
The major duties can be categorized in 3 major areas: project management, study data collection and management, and communication management.
DUTIES AND RESPONSIBILITIES
Project Management (50%) The person in this position will be responsible for all aspects of multiple clinical trials including:
Patient Recruitment, Patient Management, Study Data Management and Collection.
Conduct follow-up reviews with study participants including assessment of subject response to therapy and evaluation of adverse events; lab data review and identification of abnormal values; assessment and documentation of subject compliance with medications and visits.
Oversee and aid in the development of research protocols carried out by a variety of providers within the UW system including: physicians, technologists, nurses, etc.
Responsible for managing study budgets, including tracking of invoicing and payments to UW systems.
Develop a comprehensive understanding of the budget process and its rules and limitations.
Work independently and provide good communication with peers, Supervisor and PI’s.
Study Data Collection and Management (30%)
Oversee the accuracy and completion of all regulatory documents, IRB documents, and signed informed consent forms.
Source documentation creation and management.
Assessment, documentation, and reporting of all adverse events to the PI and IRB when applicable.
Facilitate study site visits and ensure all required documentation is available for auditors and monitors.
Enter study data on paper or electronic case report forms (eCRF’s)
Communication Management (20%)
Provide effective and timely communication with the Industry and NIH project offices, core laboratories and clinical site
The studies involve enrolling eligible participants in each study.
The Research Coordinator must have a good working knowledge of each protocol in order to address and handle issues from the project offices.
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 website, click here.
Bachelor degree in business, health sciences or related field and at least 2 years of experience working in clinical research or related healthcare field
Excellent communication and organizational ability
Experience with Microsoft Office 2007, the Internet, eCRFs
Knowledge of IRB application processes, and FDA regulations
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Experience working with industry-sponsored clinical trials and physician-initiated studies, preferably device studies
CONDITIONS OF EMPLOYMENT
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.