August 10, 2007

New VUSN program focuses on clinical research

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Lois Wagner, Ph.D.

New VUSN program focuses on clinical research

This fall, Vanderbilt University School of Nursing will unveil its new Clinical Research Management Specialty program, a curriculum designed to meet the growing demand for qualified research professionals for pharmaceutical and medical device trials.

“There is recognition across the board that we really need very skilled, highly educated clinical research personnel to manage clinical trials,” said Linda Norman, D.S.N., R.N., senior associate dean for Faculty at VUSN. “It's a very complex industry and nurses are well-positioned to play an important management role.”

VUSN has offered continuing education courses in clinical research management for several years and recently, faculty have been working to bring the curriculum to the next level. Only a handful of other nursing schools offer programs in this field.

Lois Wagner, Ph.D., A.P.N., director for the new program, gathered an advisory committee comprised of experts from the Vanderbilt community as well as the private sector to develop a well-rounded educational program that would allow people to assume more managerial positions in clinical research management. The group has met regularly during the last 18 months to develop the comprehensive program.

“The field of clinical research is booming and one of the essential features of conducting clinical trials is having well-trained staff to manage them,” said Wagner. “Clinical research staff are essential to advancing science.”

Wagner sees a movement within the industry from an ad hoc, on-the-job training model to a more thorough education in an academic environment. VUSN's curriculum includes foundational knowledge in regulatory issues, ethics and history as well as areas that are not included in many other programs, such as informatics, human resources and practical experiences with a mentor.

Registered nurses are prized in clinical research because of the diversity of their educational backgrounds and relevant skill sets such as critical thinking, problem solving and assessment capabilities. A series of town hall meetings conducted at VUMC a few years ago cited a shortage of research nurses as a limiting factor in the research enterprise.

The Clinical Research Management program will start with approximately 15 students this fall and will grow in coming years. The VUSN program is completely online with a rolling enrollment. It is targeted to nurses who already have full-time jobs, so the program is part time and can be completed in two years.

“We have high hopes for this program and Lois is the perfect person to run it,” said Norman. “Her experience and love for clinical research management will infuse our students.”

Wagner has been involved in research for 23 years. She earned her master's and Ph.D. from VUSN. She started her career as a nurse practitioner in occupational health but moved into the field of clinical trial research in 1987 when she joined Department of Pediatric Infectious Diseases as the clinical research manager of the AIDS Vaccine Evaluation Unit (now the HIV Vaccine Trials Unit).

During her career in clinical research she has managed multiple pharmaceutical and NIH-sponsored clinical trials, and has done international training and consultation on the initiation and conduct of HIV vaccine clinical trials. She also serves as the associate director for research for the Tennessee Center for Nursing, a non-profit nursing health services research organization, and the research arm of the Tennessee Board of Nursing.

“We are seeing more and more demand for this area of education from nurses and others working in the field who realize they need further training,” said Wagner. “And, the demand for this specialized knowledge base will only continue to grow.”