MSHS in Clinical Research Administration: Curriculum

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.

The Clinical Research Industry 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.

Key stakeholder roles, responsibilities, and processes associated with monitoring, auditing, and oversight in clinical trial conduct.

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.

Basic concepts and methods of biostatistics applied to translational research. Topics include distributions, populations and sample selection, variables, interaction and confounding, hypothesis formulation, correlation, t-tests, ANOVA, regression, and chi.

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.

Overview of principles related to leadership, including theories and styles, organizational management and values, communication strategies, and change in the context of healthcare systems.

Overview of business principles related to health care systems and leadership, focusing on strategic management of health care service delivery in various settings. Credit cannot be earned for this course and HSCI 6241.

Analysis of the strategies and methods of clinical research in international settings; explore cultural and ethical consideration in global clinical research projects.

Foundations of regulatory affairs, including U.S. and international legislation and regulatory processes guidelines. Roles of leaders of regulatory affairs in developing products, navigating the regulatory review and approval process, and contributing to keeping products on the market.