Salary is commensurate with experience and education
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 Cardiology in the Department of Medicine has an outstanding opportunity for a full-time Research Coordinator.
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 major duties can be categorized in 4 major areas: project management, patient recruitment, study data management and collection, and other duties as required.
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 Nurse Supervisor.
Study Data Management and Collection:
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)
Along with the Research Nurse Supervisor 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.
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.
The Research Coordinator will also provide significant contributions to identifying and defining research problems and designing new research protocols. Working closely with the Principal Investigator, the coordinator may be responsible for writing new protocols and following the complex rules and regulations to obtain approval.
The Research Coordinator will assist with identifying and attaining new research grants and contracts. This includes understanding the development of budgets for the research grant and contracts, working with the Clinical Research Budget and Billing (CRBB) office, negotiations with the sponsor, submitting regulatory documentation and all other aspects of study start-up. Once the study has started, the coordinator will assist with budget income and expenditures, invoices and budget reporting to the Principal Investigator.
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 3 years experience working with the public or patients
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 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.
CONDITIONS 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
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.
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