Clinical Trials
Management Certificate
Program description
The
field of health care has never been so dynamic and challenging
as it is today with many diverse career opportunities that
fall under the health-care umbrella. Clinical research is
one such opportunity. The discovery and approval of new drugs
will continue to revolutionize the healthcare industry for
years to come. The Clinical Trials Management certificate
program is one way to help prepare interested professionals
for a new career in pharmaceutical and device development.
This certificate program will introduce individuals to the
knowledge and skills that are needed to enter the exciting
field of clinical research.
Joann DiLiberto, RN, MS
Senior Study Delivery Operational Specialist, AstraZeneca
The certificate
program in Clinical Trials Management provides a broad overview
of key competencies necessary for a successful understanding
and conduct of the new product development process in today’s
environment. The program covers the logistics of site management,
including start up, maintenance, and close out, with the corresponding
collection and management of data. The program emphasizes
the regulatory, privacy, and compliance issues critical to
the successful approval of a new product for launch. The issues
that the current environment poses for new product development,
both in the U.S. and globally, are discussed and the students,
through team simulations and interactions with experts in
the field, are challenged to find ways to minimize their impact
on new product delivery. The various roles integral to the
development process are presented with focus on how they interrelate
in a team model. The role of the trial subject/patient is
described, with emphasis on safety and benefits potentially
achieved in investigative trial participation.
Who
should participate?
This
certificate is appropriate for those professionals who have
a strong science and/or health-care related background, including,
but not limited to, nurses, pharmacists, medical technologists,
and physicians. Most employment opportunities in the industry
require a minimum background of a bachelor’s degree.
Two years of college level education are required for admission
into the certificate program.
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