Research Clinical Trial Coordinator
This new certificate program at the University of Kansas School of Nursing begins Fall 2007 as a non-credit course consisting of 129 hours of Clinical Trial Coordinator coursework and 60 hours of practicum. This is a series of 3 courses, over an 18 month time frame. The sequence of classes consists of pre-study activities, then during-studies and ends with the post-study activities and designated practicum experience. The comprehensive approach of these courses would complete the necessary educational experience for students to enter into this field to be able to apply for testing in the National Certification opportunities.
Clinical Trial Coordinators are vital to Clinical Trial Research Studies for new drug development process. With the recent explosive growth in research activities at the University of Kansas Medical Center and the greater Kansas City area, the demand for individuals to run research studies has also grown dramatically.
Course 1:
This course is designed as an introduction to the research coordinator role and provides in-depth knowledge of Pre-Clinical Trials Study activities. Regulatory, administrative and ethical issues will be presented as well as the daily operational requirements (study design, financial aspects, protocols, hiring of personnel, subject recruitment, etc.) to begin a study.
Course 2:
This course is designed as an introduction to the research clinical trial coordinator role and provides in-depth knowledge of during-Clinical Trial Study activities. The process of conducting the day-to-day” operations of a research study; subject recruitment, data collecting forms and documenting subjects’ responses to the interventions, audits, inspections, budget monitoring, ethical/liability situations that may occur during the study, etc. will be addressed.
Course 3:
This course is designed as an introduction to the research coordinator role and provides in-depth knowledge of Post-Clinical Trial Study activities. The process of conducting the day-to-day operations of a research study; preparing for final sponsor and FDA visits; preparing final reports to the sponsor and IRB; evaluating sponsor, site and team members’ performance; management of data and preparing summary reports, etc. will be addressed. The course also is designed to provide students with a Research Coordinator practicum experience in selected research settings. Opportunities are provided to utilize learned details related to the role of a Research Coordinator during key phases of a Clinical Trial Study.
Requirements:
Enrollees must have a minimum of a high school degree or equivalent. However, health related education/experiences are preferred. Applications can be from nursing (LPNs, Ads, Diploma Nurses) and other health care related fields (pharmacy, dietetics and nutrition, speech, physical or occupational therapy, etc.). Application deadline for Fall admission is May 1.
For more information:
KU School of Nursing
Mail Stop 4043
3901 Rainbow Blvd.
Kansas City, KS 66160
Phone: 913-588-1882
FAX: 913-588-4531
Email: hschaag@kumc.edu
For application forms:
Rita Clifford, RN, PhD
Associate Dean, Student Affairs
KU School of Nursing
Mail Stop 2029
3901 Rainbow Blvd.
Kansas City, KS 66160
Phone: 913-588-1619
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The University of Kansas Medical Center