"Over my 19 years of experience in the industry, I've seen that professionals need better preparation in order to be successful in the ever-changing pharmaceutical/device environment. This certificate program has been designed to help individuals understand the challenges that the industry faces today and provide them an overview of opportunities for career change. Students will come away with a solid understanding of the intricacies and rigors of new product development, and be better prepared to undertake the challenges posed by today's regulatory environment." —Michele Welch, RN, MSN, Clinical Trials Management instructor
Requirements for enrollment
Clinical Trials Management Certificate participants are required to have a minimum of two years of college level education. It is expected that students entering the certificate will have a strong science and/or health-care related background. The certificate provides the fundamental knowledge to enter the field of clinical research. Students who complete the certificate program can move up the career lattice to achieve the Certified Clinical Research Professional (C.C.R.P.) credential, administered and awarded by the Society of Clinical Research Associates. A Clinical Research Professional may serve as a clinical investigator, sub-investigator, clinical researcher, research nurse, administrator, coordinator, data manager, project manager, IRB coordinator, Quality Assurance specialist, regulatory affairs specialist, research pharmacist, consultant, or educator in clinical trials management.
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.