The online MSHS in the Clinical Research Administration (CRA) requires successful completion of 36 credit hours, including: 18 credit hours in the field of CRA, 9 credit hours of strategic leadership courses, 6 credits of graduate research coursework, and a 3 credit hour elective.
Clinical Research Administration Courses
Students develop the academic skill sets necessary to succeed in this program in the context of exploring scientific, clinical and regulatory concepts required in medicines development. Students demonstrate their critical analysis skills through literature research, analysis of information from various perspectives, and formulating their own opinions in choosing their ‘defendable positions’, rather than stating the “correct answers”.
This course examines the nonclinical, clinical, commercial, regulatory and risk assessment strategies required to develop a clinical development plan for an approvable, marketable new therapeutic and propose life cycle management strategies.
This course explores regulatory, policy, ethical and practical considerations associated with the engagement, recruitment, retention and interaction with human research subjects.
This course integrates project management principles, decision-making models, cross cultural competency, and interdisciplinary team dynamics to facilitate effective and efficient conduct of clinical trials.
This course explores how to manage risk and safety assessments to ensure quality in clinical research.
Strategic Leadership Courses
Students examine leadership/leadership change theories in the healthcare industry setting, as well as management and communications strategies, and values in a systems framework. Students develop their own personal leadership philosophies through the various assignments.
Students examine the major themes on healthcare policies, trends, and issues in the major health systems and research enterprise. Students evaluate the larger contemporary issues, trends, policies, and implications that influence and shape current research and healthcare practices.
Students create the essential components of an enterprise strategic business plan. Students develop a mission and vision, strategic initiatives, marketing strategy, and an economic model for sustainability. Through preparing this type of plan, students develop their own strategic planning skill sets for implementing change.
Students integrate many of the learnings from the CRA program coursework to create a Masters level proposal intended to address a major area of a change, as well as how to implement the change management proposal, within the clinical research industry. Students initially evaluate and develop strategic alternatives through case studies prior to drafting the Master’s proposal.
Graduate Research Courses
Students develop the foundation skills in biostatistics to design and analyze a research study. Students examine topic areas such as populations, sample selection, variables, hypothesis formulation, correlation, t-tests, ANOVA, regression, and chi-square analysis. Students examine output from statistical software (SPSS and SAS), practice problems and reviews of scientific literature through assignments such as a research analysis plan.
Students explore the basic concepts of epidemiology which includes various epidemiological study designs used to examine disease frequency, cause-effect relationships between risk factors and disease states, and effects of bias as examples. Students apply epidemiologic concepts in the context of translational research.
Elective Course (choose one)
Up to nine credit hours of previously earned graduate-level coursework may be accepted as transfer credit. Please contact the program office for the full policy and guidelines.
Official transfer credit evaluations are conducted only for admitted students.