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The Cardiology Division has 51 full-time clinical faculty at three hospitals: The University of Washington Medical Center, Harborview Medical Center and the Veterans Affairs Puget Sound Health Care System. The faculty is known for excellence in patient care, teaching, and research. In fact, 10 of the 12 cardiologists listed by Seattle Magazine in 2002 as among "Seattle's Best Doctors" are full-time University of Washington faculty. Our priority is to provide outstanding care while meeting highest expectations for service to patients and referring physicians.
The Division of Cardiology has an outstanding opportunity for a full-time Research Coordinator. This position provides an opportunity to work on a research project at a national level and to travel throughout the United States.
The Division of Cardiology has been awarded a Research Coordinator position for a multicenter, randomized, controlled trial. We have been identified as the U.S. Coordinating Center whose role is to oversee the progress and activities of the study for this project. These activities will take place at the Clinical Trials Service Unit and Coordinating Center within the Division of Cardiology. This includes conducting site visits and training sessions. On a national level this group actively participates in sub-committees, study related conference calls and the planning of national meetings for the respective projects.
In relation to these awarded studies the Research Coordinator will monitor and assist in the day-to-day management of the sites in the US. The person in this position will be a liaison between the main Coordinating Center, Population Health Research Institute (PHRI), Bayer Pharmaceutical Company and the individual sites. The major duties can be categorized into 4 major areas:
Project Management, Project Involvement, Study Data Management, Leadership and Supervision.
Effective and timely communication with the Project Office at PHRI, the pharmaceutical company Bayer and the clinical sites is an essential part of this position. There are 52 sites in the United States. Some of these sites are relatively research naive and need to have frequent communication with the Research Coordinator who will act as a primary resource for trial conduct. The Research Coordinator must have an in-depth, working knowledge of the protocol in order to address and handle issues from the clinical sites.
Communication with the main Coordinating Center, the pharmaceutical company and the sites is essential so that approved changes and clarifications to the study conduct are disseminated accurately. The main Project Office (PHRI) and the pharmaceutical company rely on the Research Coordinator to communicate these changes and clarifications to the sites.
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 the sites may be having with these issues.
Leadership and Supervision
Clinical site identification along with assisting with the manual of operations, case report forms, training programs, and recruitment and adherence manuals may be a major portion of this position in the future. The person occupying this position will provide leadership for at least a half time associate.
There will be responsibility to provide leadership to a specified number of clinical site research coordinators.
The Research Coordinator is involved in a number of sub-committees within the project to assist with the smooth conduct of the trial. There are a number of issues that occur in any study but with a large study in research naive sites, additional issues may occur that need to be addressed. The Research Coordinator works with the Steering subcommittees and may serve on additional committees such as: End-points, Publications, Grants, Quality Control and Meeting Planning, depending upon the area of interest. Investigator Meetings, (includes all clinical sites), are essential in these trials and the Research Coordinator will ahve a large role in planning, contributing and conducting these meetings.
There are a number of issues that occur in any study but with a large study in research naive sites, additional issues may occur that need to be addressed. The Research Coordinator could be asked to take on additional responsibilities as needed within the trial as itprogresses. Investigator meetings (includes all clinical sites) are essential in these trials and the Research Coordinator has a role in planning, contributing and conducting these meetings. At the investigator meetings the Research Coordinator along with his/her colleagues from the Clinical Trials Service Unit and the Coordinating Center host meetings to address specific problems and issues relevant to the clinical sites.
The role of this position is to monitor sponsor and/or NIH funded studies. The excellent quality of work that is accomplished will make the Clinical Trials Service Unit more competitive for future similar positions. Even though this is a new position, some of the responsibilities for other projects will not be new.
Study Data Management
The Research Coordinator will provide monitoring of the protocol and assess the clinical site's adherence to the protocol. This is primarily completed via email or phone, but yearly in person visits are needed. Any issues or problems that the site has in conducting the trial are identified and a debriefing with the study coordinator and local PI at the site may be necessary. Follow up communication via a written report is important so that the status of the sites adherence is known, evaluated and recorded.
Routine, training and for-cause site visits are required on all sites involved in the studies. The responsibilities of the Research Coordinator during these visits center around Site Monitoring activities: to assess the clinical site's adherence to the protocol by doing chart review, source document verification, informed consent review and extensive regulatory review to ensure all applicable ICH-GCP guidelines are met. Any issues or problems that the site has in conducting the trial are identified and a debriefing with the study coordinator and local PI at the site is necessary. Follow up communication via a written report is required to document site adherence.
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 in Nursing or related field, and at least five years of clinical experience in a hospital, clinic or patient or health education area. |
Current license to practice as a registered nurse in the State of Washington.
Previous experience as a research coordinator, preferably with an NIH funded study. Prior site monitoring experience is preferred.
Excellent communication and organizational ability.
Experience with personal computers, the Internet,
Experience with case report forms development and completion, IRB process, FDA regulations.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
| Appointment to this position is contingent upon obtaining satisfactory results from a criminal background check. |
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.