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.
At the University of Washington, diversity is integral to excellence. We value and honor diverse experiences and perspectives, strive to create welcoming and respectful learning environments, and promote access, opportunity and justice for all.
The School of Medicine’s 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 Clinical Trials Unit (CTU) at the University of Washington supports these 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.
Cardiology has an outstanding opportunity open for a Temporary, Full-Time Research Coordinator.
The major duties can be categorized in 4 major areas: project management, patient recruitment, study data management and collection, and other duties as required.
Study Management 30%: Patient Recruitment, Patient management, Study Data Management and Collection: Manage implementation and ongoing activities of clinical trials such as Screening, Recruitment and Enrollment of patients. Produce enrollment/follow-up plans and communication tools to enable physicians to facilitate the study. 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 research protocol activities carried out by physicians as directed by the Research Manager.
Study Data Management and Collection 30%: Assist with overseeing the accuracy and completion of all regulatory documents, IRB documents, and signed informed consent forms. Source documentation creation management. Assess documentation of all adverse events, determine severity and report events to PI and IRB. Facilitate study site visits and ensure all required documentation is available for auditors and monitors. Manage all activities related to a study qualification visit, initiation visit and study closeouts Enter study data on paper or electronic case report forms (eCRF’s)
Other Duties 25%: Along with the Research Manager this person will work on individual protocols. This person will be required to perform research duties including obtaining laboratory samples and sending out to core labs as required, obtaining Hazard shipping certification. Undergo required Human Subjects Training and Good Clinical Practice (GCP) training.
Communication Management 15%: Effective and timely communication with the Industry and NIH project offices, core laboratories and clinical sites (UWMC, HMC) is an essential part of this position. 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. This position may also involve the development of clinical research protocols and supportive budgets.
As many of these large trials utilize Core Laboratories for the sites to send the samples, the Research Coordinator must know how the Core Laboratories work, the procurement and shipment of samples and how to solve any problems related to these issues.
Requirements: Bachelor's degree in a related field and at least 1 year of research experience
Additional Requirements: 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.
Desired: Experience working with cardiovascular disease including coronary artery disease, PFOs, STEMI, valve disorders, heart failure, electrophysiology, congenital heart disease. Experience at UW working with IRB, CRBB and OSP.
Condition of Employment: Appointment to this position is contingent upon obtaining satisfactory results from a criminal background check. The ability to have a flexible work schedule, both in the number of hours and days is required by participant enrollment. Ability to climb stairs to work station. Ability to travel to investigator meetings. Availability to work with a research team to answer questions or assist them in whatever is needed as a trial liaison.
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, 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.