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.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. The Division of Cardiology has an outstanding opportunity for a Research Study Assistant. This position supports the CTU Manager and Research Coordinators within the Division of Cardiology in the conduct of both NIH and industry sponsored clinical trials. The Research Study Assistant will work independently throughout the day and will communicate with the Research Coordinators as needed. This position may also support working with some of the Cardiology Faculty on special projects. RESPONSIBILITIES:Serve as contact with study participants, explain purpose of research study and protocols. Screen prospective participants to determine eligibility according to research criteria. Review and explain consent forms, questionnaires and surveys with prospective subjects. Perform technical tasks such as venous blood drawing, administer electrocardiograms and vital signs. Assist with processing of laboratory specimens. Assist in dispensing and retrieving medication under the direction of a health care practitioner.Communicate with many different groups and people outside of the research staff, including outside physicians and their offices (both written and oral); study sponsors and CRO's (contract research organization) as well as sites about specific study issues; other departments within UWMC and UW pertaining to a specific study. Contact directly to clinical sites and research coordinators for required regulatory clinical trial documents. Maintain all the study specific regulatory documents/binders to include photo copying, filing, obtaining updated CV's licenses and communication to the sponsor regarding these items. Set up study tools, handle complex scheduling of patients for assessments with Cardiology Clinic, Radiology, Cath Lab, Pre-Anesthesia, and send out reminder letters. Independently complete simple IRB documents (both WIRB and HSD) for submission. Obtain input from Research Coordinators and primary investigators for more complex submissions. Handle submission of study data, tests and labs to the sponsor or Core Lab. May need to de-identify and re-label data. May need to obtain dry ice for shipments. Submission of blood samples will require additional Environmental Health and Safety Training. Experience with data transfer systems required; to include Imtelemage and Bioclinica and MDDX. Data entry, either on paper or electronic case report forms of information obtained for a study. May include contacting study subjects (by phone or mail) to obtain information. Review and correction of submitted trial documents and uploads to central server. Experience with iDataFax,and TrialNetworks, preferred. Work with the Research Coordinator and Cardiology Fiscal Office to review study visits and related payments to assure accurate billing and reimbursement. Review budget activity and budget status reports for reimbursements. Track study procedures completed and match them up with study reimbursement. Order study related supplies; may include study device ordering and receiving, laboratory kits, study report forms, shipping documents and destruction of outdated lab kits. REQUIREMENTS:Two years of college-level course work in a relevant academic area AND one year of appropriate experience OR equivalent education/experience. DESIRED:Previous experience with Intelemage and Bioclinical. Previous experience with IRB applications. 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, Cover Letter and/or others.? Any assessments that you need to complete will appear on your screen as soon as you select
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.