West Windsor, NJ: After a pilot program that began in January, Mercer County Community College's Center for Continuing Studies (CCS) will offer four clinical trials courses this fall that are targeted to those seeking careers in the growing field of clinical research. Entering students must have a bachelor's degree in health care or science. Those who successfully complete the program may be eligible for internships in the industry.

The curriculum was developed in response to industry needs, through a Central New Jersey Bio 1 Workforce Innovation in Regional Economic Development (WIRED) grant. Because MCCC has been teaching a program in Drug Development and Clinical Research for the past ten years, it was uniquely suited to develop the new course for the biotech industry. Mercer relied on its extensive contacts in the industry and conducted focus groups to help them design the program.
According to CCS Dean Dr. Lynn Coopersmith, the program is an excellent opportunity for dislocated workers or those seeking a career change. "The courses provide a thorough foundation in the clinical trials process and the skills and knowledge required for entry level positions. Participants in the internship program gain a realistic understanding of the challenges and expectations in a clinical trials work setting, and have a competitive advantage in their job search."

The program saw 27 students recently complete the initial two courses. Several have worked in internships, including Leonel Jean-Baptists of West Windsor, who worked at MDS/Celerion for six weeks. He says he would definitely recommend the program. "This is good for people who work in a scientific field who have the hands-on experience but don't know the rules and regulations. They need this theoretical training."

Vasanti S. Anand, Ph.D., who interned at Amicus Therapeutics, said "I have gained a lot from the program. I learned the nuances of clinical research and the drug development process, and it enabled me to think like a clinical scientist. The program equipped me with all the basic knowledge and regulatory guidelines needed for this internship."

The first class in the series, "Foundations of Clinical Research and Study Design," is a prerequisite for future classes. This fall the class will meet Sept. 15 through Nov. 17 on Wednesday evenings and Saturdays. It covers the fundamentals of new pharmaceutical research and clinical trial methodology. Students will design a clinical trial, develop a study protocol, and learn assessment and reporting of adverse events, and establish guidelines for reporting study results.

The other three courses are, "Data Management," "Clinical Research Coordinator/Clinical Research Associate (CRC/CRA)" and "Regulatory and Legal Issues in Drug Development."

Anand said the CRC/CRA course was especially useful for her. "The course gave me insight into protocol development, clinical research, and GCP, ICH guidelines, and a lot of regulatory information," she said.

An Information Session for potential students is scheduled for Thursday, Aug. 26 at 5:30 p.m. Dr. Coopersmith strongly encourages potential students to attend. To register or request further information, e-mail ComEd@mccc.edu or call (609) 570-3311.

Employers interested in considering interns or program graduates, or in working with the college on further program development, are invited to contact Dr. Lynn Coopersmith at coopersl@mccc.edu, or call 609-570-3241.