Making sure the drugs in our medicine cabinets are both safe and effective is partly the responsibility of clinical research professionals, the scientists vested with managing clinical trials and closely following federal regulations. Technological advances leading to the development of more drugs and medical devices have created a growing demand for clinical research experts.
Rochester Institute of Technology will announce the launch of a new graduate program focused on clinical research management during a conference on the Current and Future State of Clinical Research on Thursday, April 10, at RIT. The daylong symposium will begin at 8 a.m. and is sponsored by RIT’s Center for Bioscience Education and Technology.
RIT’s new master of science program will be offered this fall through the Center for Multidisciplinary Studies in the College of Applied Science and Technology. The degree program is the only one of its kind in upstate New York. Comparable programs on the East Coast are offered at Boston University, Drexel University, George Washington University and Temple University.
Moving a drug through the approval process to the marketplace—or “from the bench to the bedside” can take an average of 12 years and $1.2 billion, says Douglas Merrill, director of the Center for Bioscience Education and Technology, with only a fraction of the proposed drugs and medical devices ever being developed.
“Due to this huge investment, it is crucial to have highly trained professionals involved in all aspects of the research development process,” Merrill says.
“Clinical research associates monitor or audit the quality of data from clinical trials and ensure compliance with federal regulations and clinical trial protocols,” says RIT alumna Lorraine Ellis, the president and CEO of Research Dynamics Consulting Group LTD. She founded Research Dynamics 15 years ago to provide clinical research management and other clinical research services to the pharmaceutical, biotech and medical device industry.
“There are many companies and healthcare organizations in upstate New York and across the USA who need these graduates,” Ellis adds. “There is a shortage of trained and experienced staff in medical product development due to the rapid growth of these companies. There are very few degree programs in this area that provide the skills with the knowledge so that graduates can provide effective job performance from day one.”
Ellis and fellow alumnus Nicolas Samper are members of CBET’s Clinical Research Advisory Board that assisted in the development of RIT’s new program. Samper is a clinical site manager with AMGEN Inc., a bio-pharmaceutical organization.
“Pharmaceutical, biologic and medical device organizations are constantly looking to hire qualified people with knowledge of clinical research in order to improve the quality, speed and cost effectiveness of clinical trials,” Samper says. “RIT is committed to working with industry and medical partners to ensure this program provides quality candidates to fill their needs for better managed clinical research tasks.”
RIT’s program in clinical research management is a good fit for students aspiring to work in industry, academia, healthcare organizations or for the government. Students can enroll in part- or full-time study.
“In clinical research management, there is not a clearly defined academic route to gain the skills necessary to enter this job market, and there are very few candidates to fill the current need,” Samper says. “This new program looks to build upon students’ life science or nursing backgrounds and give them the skills necessary to enter the market or to become more competitive when moving up the clinical research career ladder.”
The new graduate degree will also be added to existing bachelor of science programs in biomedical sciences and biotechnology, following the popular “4 + 1” format that allows students to earn both their bachelor’s and master’s degrees in five years.
Rochester Institute of Technology is internationally recognized for academic leadership in biotechnology, computing, engineering, imaging technology, and fine and applied arts, in addition to unparalleled support services for students with hearing loss. More than 15,800 full- and part-time students are enrolled in RIT’s 340 career-oriented and professional programs, and its cooperative education program is one of the oldest and largest in the nation.
For nearly two decades, U.S. News & World Report has ranked RIT among the nation’s leading comprehensive universities. The Princeton Review features RIT in its 2007 Best 361 Colleges rankings and named the university one of America’s “Most Wired Campuses.” RIT is also featured in Barron’s Best Buys in Education.