Clinical research management is a dynamic
profession requiring coordination with multiple departments, institutional
offices, and investigator teams. Effective research administrators need a deep
understanding of clinical research management to be effective in successfully
executing their role in the process. This module explores the management and
administration of clinical research from study initiation to contract
close-out, with an extensive focus on regulatory responsibilities, budgeting
and finance, and project management. The emphasis throughout the module is
placed on the importance of protecting human subjects, their data, and the
integrity of the research process.
- Describe the history and regulations associated with human experimentation and the protection of human subjects in research.
- Identify the institutional oversight and management requirements that ensure compliance for its programs involving human subjects research.
- Understand the roles, processes, and responsibilities for research administration and management professionals conducting clinical research involving research participants during pre-study activities, study conduct, and study completion.