New Initiative Trains Nurses to Manage Clinical Trials

January 24, 2008

"Most clinical trials involve complex biological, psychological and social variables that nurses are particularly adept at navigating."

In response to the overwhelming need to safely and expeditiously bring drugs, vaccines and medical devices to the people who need them, the University of Rochester School of Nursing has launched a new, comprehensive training course aimed at giving nurses and other health care professionals the education they need to manage clinical trials.  A critical step in moving medical advances from the research phase to the marketplace, clinical trials are run by researchers and principle investigators, but often managed by individuals with little or no formal training in clinical trials research.   

The course, entitled “Managing Clinical Trials: A Comprehensive Continuing Education Course for Healthcare Professionals,” will focus on the structure, regulation, and financing of the clinical trials industry, aspects of the pharmaceutical development process, ethics and regulations of clinical trials, study implementation, data collection and management, patient recruitment, and study conclusion.   The school has partnered with Global Research Services, LLC, an international contract research organization with an established history in clinical trials research, to provide students with expert faculty and comprehensive curriculum. The course, a University of Rochester Medical Center initiative, will be administered though Edvantage, the school’s healthcare career development arm.

“Most clinical trials involve complex biological, psychological and social variables that nurses are particularly adept at navigating,” said Donna Tortoretti, CEO of the Center for Nursing Entrepreneurship at the School of Nursing.  “Their clinical training, communication skills, ability to manage data and understanding of the importance of clinical research make them ideal candidates to work in this important and growing field.”

Upon completion of this course, participants will be able to: Describe the structure, regulation, and financing of the clinical trials industry; evaluate the clinical trial aspects of the pharmaceutical phase development process; differentiate the various roles and responsibilities of clinical trials professionals as a collaborative, integrative multidisciplinary team; analyze principles of ethical conduct ; apply federal standards to clinical trials; examine current trends in patient recruitment and retention to promote effective study outcomes; and appraise regulatory issues for patient protection and safety during a clinical trial.

The course is a 40-hour, Web-based, interactive program that is delivered in a self-paced, online learning format and facilitated by an instructor. Technical support is available 24 hours a day, seven days a week. Upon successful fulfillment of the course requirements, students will receive a certificate of completion, continuing education hours, and the skills and knowledge necessary for a career as a clinical research coordinator or associate.  An optional internship is available for interested participants and mentoring, meetings, and support via telephonic conferencing.

To register for the course please call (585) 275-0446 or visit

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