Health Science MHS

The MHS in clinical research administration is a 31-credit program (inclusive of the 10 hours of required MHS core credits) that will produce graduates with a wide array of knowledge encompassing various approaches to evidence generation, translation, and application. Objectives for the clinical research track are drawn from competencies established by the Agency for Healthcare Research and Quality (AHRQ) for clinical research. Upon completion of the program students will be able to:

• Discern the knowledge and skillsets available from clinical research approaches needed to address specific health care issues and problems.
• Synthesize meaningful, relevant, and important research questions that address important health care and public health problems that can be informed by systematic reviews of the literature, needs assessment, and relevant theory and concepts.
• Select appropriate interventional, quasi-experimental, or observational study designs to address specific clinical research questions.
• Collect primary health and health care data obtained by survey, qualitative or mixed methods, as well as assemble and integrate secondary data from existing public and private sources.
• Defend the ethical and responsible design, implementation, and analysis of specific clinical research programs.
• Select the appropriate analytical methods to clarify associations between variables and to discern causal inferences.
• Design, construct, and deliver written and verbal communication about the findings and implications of particular clinical research programs for both professional and lay audiences.

Many of the graduates will likely also have PharmD degrees or degrees in other clinical or life sciences to bring a knowledge and understanding in therapeutics and health-care delivery to their clinical research course of studies. Graduates will be highly skilled, marketable scientists who can apply their knowledge and skills in an array of health care areas conducting or benefiting from clinical research.

This program is offered under the auspices of the FDU School of Pharmacy, Maxwell Becton College of Arts and Sciences, Florham Campus, Madison, New Jersey.

Clinical Research Administration Requirements

• CLIN7104 Clinical Research Administration Capstone (3 credits)
• CLIN8812 Clinical Trial Research Administration (3 credits)
• CLIN8821 Regulatory Compliance for Pharmaceuticals (3 credits)
• HSCI7810 Clinical Trial Design and Regulatory Requirements (3 credits)
• HSCI8810 Medical and Clinical Report Writing (3 credits)
• HSCI8822 U.S. Regulatory New Drug Application and Submission and Dossier Preparation (3 credits)

The MHS regulatory science track is a 31-credit program (inclusive of the 10 hours of required MHS core credits) designed for preprofessional students who are seeking further specialization in regulatory sciences and for working health care professionals who are looking to enhance their standing within this growing and evolving field of study.

Educational programming will provide students with

• a working understanding of regulatory history and theory,
• federal and state regulatory structures relevant to health care products and professional practices,
• regulatory compliance methods in the health care industry,
• health care product patent-licensing processes and
• the common research methods used in supporting product-licensing applications.

The primary goal of this degree program will be to prepare students for taking on significant roles within government agencies, pharmaceutical and biotechnological industries, and health care provider organizations, as well as in other sectors of the health care industry where compliance and regulation are crucial. The program will allow students to develop a comprehensive understanding of the protocols, procedures, statistical analysis, assessment or risk/benefit, documentation, and legal and ethical concerns that play a critical role in the day-to-day responsibilities of the field.

Upon completion of this program, students will be able to:

• Demonstrate the constituent elements of federal and state regulations of healthcare delivery and manufacture and distribution of pharmaceuticals and biologics in the U.S.
• Compare and contrast the governmental regulatory approaches for the manufacture and distribution of pharmaceuticals and biologics in the U.S., Canada, Europe, South America, and Asia.
• Generate statistical analyses and reports acceptable to governmental regulatory agencies in the U.S., Canada, and Europe.
• Evaluate regulatory applications for new products or professional practices against applicable regulations, standards, and guidance.
• Discern the moral, legal, ethical, and financial implications of research data or licensing applications for specific pharmaceutical or biological products.
• Detect legal and regulatory requirements that can pose harm to patients and undue disruption to health care operations.
• Identify conflicting regulations at local, state, and federal levels and evaluate ways to reconcile them for affected constituencies.
• Identify gaps in regulatory processes for particular health care products and services and propose policy solutions.

Graduates who achieve these objectives will be prepared to assume responsibilities requiring competencies associated with Level I and Level II of the Regulatory Science Professional Development Framework produced by the Regulatory Science Professional Society. Because most of the graduates of this program will have formal education in pharmacy or other health care professions, they will bring added dimensions to the knowledge and skills they acquired in regulatory sciences. Graduates will find rewarding career opportunities in health care provider organizations, health care consultancies, health care research and manufacturing industries, insurance providers, pharmacy benefit managers, and state and federal government agencies.

Regulatory Science Requirements

• HSCI7810 Clinical Trial Design and Regulatory Requirements (3 credits)
• HSCI8810 Medical and Clinical Report Writing (3 credits)
• HSCI8822 U.S. Regulatory New Drug Application and Submission and Dossier Preparation (3 credits)
• REGS7104 Regulatory Affairs Capstone (3 credits)
• REGS8812 Clinical Trial Research Administration (3 credits)
• REGS8821 Regulatory Compliance for Pharmaceuticals (3 credits)

Careers

FDU’s Master of Health Science (MHS) program is responding to the growing demand for educated and highly skilled professionals in the pharmaceutical industry, in health care delivery, and in health science-related fields.

According to the Bureau of Labor Statistics, jobs in the health sciences are expected to grow between 25% and 35% by 2020. The metropolitan NY/NJ area has long been at the center of the world’s pharmaceutical and health sciences industries. New Jersey is now home to 300 biotechnology companies, and 20 pharmaceutical and medical technology firms — and 17 out of the world’s top 20 have major facilities in the state.

Summary of career growth potential

The growth of employment opportunities within the health sciences has been marked and dramatic over the last decade, and projections indicate exponential growth for these areas by the year 2020. Careers in this area have both high earning potential and significant opportunity for growth, making these fields desirable for students. Many organizations involved in the pharmaceutical industry, health care delivery, and health science-related fields place significant value on graduates with the knowledge and skills that are translational across traditional boundaries in health care. FDU’s MHS equips students with tangible skills that will provide them with opportunities for employment in areas that are growing much faster than the rate at which graduates can be produced.

The Master of Health Science in clinical research administration and regulatory science also address the filling of a void that few educational institutions have addressed. Some local graduate programs provide some content within this area of study, though they are not designed to create specializations to serve particular areas of health care. The emphasis this program places on prescription-drug use, in conjunction with its affiliation with the School of Pharmacy and Health Sciences, provides unique opportunities for synergy and collaboration between the students and faculty.

The area of clinical research administration is a fast-growing and rapidly changing environment. Not only are there increasing needs for evidence to address the safety and efficacy of new medical technologies, but there is also a demand from payers for evidence as it relates to effectiveness and efficiency. Professional career opportunities in this area seem to be increasing at a faster rate than ever before, with the advent of new biotechnology corporations that are emerging throughout the world and existing corporations continually pushing forward into new areas of advanced research. In fact, the Bureau of Labor Statistics projects a 40 percent increase in demand for medical scientists within this area of work from the period 2008–2018. A critical need for scientists with the ability to conduct rigorous, ethically grounded, and credible research will continue to grow into the future.

Regulatory-science specialists are also in high demand, and the New Jersey area has a greater opportunity than ever before due to the influx of biotechnology and small-market pharmaceutical companies engaged in the development of new products. These entities are constantly in need of experts who can navigate the complex regulatory pathways toward product approval. This career, chosen as one of CNNMoney magazine’s “Best Jobs,” has a projected job-growth rate of 25 percent. Opportunities for employment will be bolstered by a master’s degree in this area, as very few programs educate and train students to attain this skill set.

Director

Dr. Yong Guo