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."
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."
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.
three courses are, "Data Management," "Clinical
Research Coordinator/Clinical Research Associate (CRC/CRA)"
and "Regulatory and Legal Issues in Drug Development."
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.
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 firstname.lastname@example.org,
or call 609-570-3241.