Clinical Trial Manager Graduate Certificate

This course provides a framework for the implementation of Enterprise Risk Management as a means for implementation of a comprehensive risk management process and plan that encompasses the entire enterprise, which crosses departmental barriers. Course topics include: enterprise risk management (ERM) and its evolution, risk financing methods, contract management, claims management, environmental compliance, human research, peer review and credentialing, due diligence in business transactions, consent to treatment, advent of e-discovery rules and the impact of the electronic health record (EHR). Students will be expected to complete a case study on the implementation of enterprise risk management in a health care setting of their choice.

This introductory course will assist learners to blend conflict-resolution theories, models, and skills into realistic strategies that can be utilized in a healthcare setting. The attitudes, knowledge and skills from this course can be applied to those who deliver, receive, and manage healthcare. The strategies will be applicable to working with diverse populations, including people with different cultural backgrounds, genders, personalities, positions of power, agendas. Types of negotiation strategies in order to move toward a collaborative situation will also be addressed.

Good decision-making in healthcare is enhanced through empiricism, where formal processes are used to ask pertinent research questions, review the professional contributions of others, develop appropriate methodologies, obtain reliable and valid data, organize data into formal data sets, conduct suitable statistical analyses, and make informed judgments. This course provides background in both theory and practice in statistics and research methods, in part to prepare students for the many activities associated with clinical research.

This course provides students who have completed the clinical research associate certificate program additional knowledge and understanding of the role and skills required of a clinical Trial Manager. This course will include lecture, case studies, and student participation in presentations, role-play assignments, and written reports.