Master's in Clinical Research Management Curriculum

The Research Design and Methods in Clinical Research course addresses scientific, clinical, and regulatory concepts required in medical agent and/or device development. Students will explore ethical design and methods used in clinical research, measurement issues in conducting research across diverse populations, and appropriate statistical measurement and analysis for given study designs. Issues concerning practical considerations and rare disease studies will also be included. Intended for all graduate students in Clinical Research Management (CRM).

The Data Analysis and Interpretation in Clinical Research course introduces the principles of biostatistical methods used in biomedical and public health research. Analysis of clinical trials data and interpretation of statistical results in biomedical studies will be emphasized. Intended for all graduate students in Clinical Research Management (CRM). C—CRM 701

The Clinical Operations and Project Management course integrates project management principles and clinical operations by exploring 87 regulatory, policy, ethical and practical considerations associated with the engagement, recruitment, retention and interaction with human research subjects. Operational planning of clinical trials are discussed, including budgeting, study timeline, site evaluation and selection, study initiation, content and timing of monitoring visits, quality assurance, study closure procedures, decision-making models, cross cultural competence and interdisciplinary team dynamics. Intended for all graduate students in Clinical Research Management. P—CRM 701 or POI.

The Leadership and Professionalism I course covers essential skills and knowledge areas related to clinical research management. Participants assess their own leadership skills and knowledge and develop a specific plan for leadership skills development. This course also develops skills for team management and leading an organization toward goals accomplishment. Participants acquire knowledge and develop skills through case studies, experimentation with their own behaviors, and feedback from faculty and peers. Intended for all graduate students in Clinical Research Management.

The Leadership and Professionalism II course covers essential skills and knowledge areas related to clinical research management. Participants assess their own leadership skills and knowledge and develop a specific plan for leadership skills development. This course also develops skills for team management and leading an organization toward goals accomplishment. Participants acquire knowledge and develop skills through case studies, experimentation with their own behaviors, and feedback from faculty and peers. Intended for all graduate students in Clinical Research Management. P—CRM 703

The Ethical and Participant Safety Considerations course examines clinical trials management topics within an ethical context. Ethical issues confronted by most organizations and the approach to ethical decision-making are discussed. Topics include conducting research with vulnerable populations, conflict of interest and scientific misconduct. Students will develop study protocols, progress reports, journal publications and scientific presentations. Intended for all graduate students in Clinical Research Management.

The Medicines Development, Regulation, Industry course explores legal and regulatory decision-making as well as the structure and role of key U.S. and international regulatory bodies. Participants explore how healthcare is regulated. Risk management, public health, and product/drug regulations are discussed. Other topics include changes to healthcare and advancement in technology. Intended for all graduate students in Clinical Research Management.

The Clinical Studies Development course examines the nonclinical, clinical, commercial, regulatory and risk assessment strategies required to develop a clinical development plan for an approvable, marketable new therapeutic or device. Intended for all graduate students in Clinical Research Management.

The Quality Systems and Risk Management course explores how to manage risk and safety assessments to ensure quality in clinical research. Students will examine how management concepts and training methods are used in managing risk and ensuring quality. Other topics include post marketing for new products and data quality assurance methods. Intended for all graduate students in Clinical Research Management.

The Data Management and Informatics course provides an introduction to database design, data management, quality assurance and technology assessment in clinical research administration. Topics include establishing budgets for clinical trials, methods for tracking participants and findings, complexities of ethical data management, and evaluation of data sources and data quality. Intended for all graduate students in Clinical Research Management.

This course studies key management concepts and roles of management and how they apply in successful, dynamic organizations. Students will examine the competencies of effective managers in developing customer focus, planning, selecting and developing individuals and teams, communicating, managing resources, using technology and being adaptable. Additional topics include the theory and process of effective negotiation and various team building and conflict resolution strategies in a variety of contexts.

This course focuses on developing effective business communication skills for professionals in managerial/senior roles in health care and life sciences. Writing scenarios include: preparing briefings and updates using presentation software and/or briefing packets; organizing data; constructing proposals and reports; solicitations; coordinating projects via email; and drafting and editing group documents. On-the-job examples from each participant’s workplace are used throughout the course.

In this course, participants will learn how to solve complex business challenges and promote industry leadership with a systematic approach to creativity and innovation. Design will be used as a practical, everyday process to spur innovation, organic organizational growth and effective strategy implementation. Topics include the best procedures for generating and testing concepts, how to engage customer feedback and solicit new ideas, and testing assumptions to discover which problems/solutions matter the most to customers.

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. The curricula is designed to take participants through the entire lifecycle of a project while assessing organizational, cultural and personnel factors that influence successful clinical trial performance.

This course focuses on the area of financial management as applied to healthcare and life sciences organizations. The emphasis in this course is to apply the principles and concepts of financial management to health and life science providers that represent innovative new structures and organizations, such as Accountable Care Organizations (ACOs) offering integrated patient care. Participants will gain competency in the application of financial and analysis tools and techniques internationally through a case study approach. Upon completion of this course, participants will be able to utilize a comprehensive range of tools and techniques that can assist them in future financial decision-making in complex, multinational healthcare and life science organizations.

This course focuses on the technical writing skills required for the regulatory professional. Students will construct coherent written regulatory documents using “Plain Language” techniques, synthesize valid, scientific information to support regulatory decisions, and appraise supporting regulatory documents and exhibits for appropriate use in argument development. Additional topics include how to constructively critique, evaluate and revise written documents and oral presentations.

The Capstone Experience course is an independent or group project that spans the duration of the Clinical Research Management graduate program. Participants identify a critical challenge related to healthcare and work collaboratively with peers, colleagues, course faculty, advisors and chairs to integrate various perspectives across healthcare sectors and develop possible solutions to the identified challenge. Participants draw upon knowledge and skills from their coursework with an emphasis on collaborating across healthcare sectors, considering strategies and ethical implications, communicating effectively and developing feasible, viable and transformative solutions. Intended for all graduate students in Clinical Research Management.

The capstone experience is delivered semesters 2, 3, and 4 (1 credit hour each) and semester 5 (3 credit hours).