Recent growth in clinical and translational research has heightened the need for a competent clinical research workforce in industry and academia. While government organizations re-engineer the clinical research enterprise and ensure compliance with federal regulations, pharmaceutical companies seek to improve the breadth and efficiency of clinical research and maintain quality and safety standards. Pharmaceutical companies and research sites must ensure the research process is safer, more efficient and compliant, while bringing much needed products to market in a reasonable time frame to improve patient health. These requirements demand a much more highly skilled and developed clinical research leaders to address the increasing complexity of clinical research and regulatory administration. The MCRRA curriculum is designed to ground clinical research staff in the regulatory requirements regarding the conduct of clinical research and then build on that knowledge, enabling graduates to better understand and affect developments in the field from technical, theoretical and managerial perspectives. It also enables clincal research professionals to develop clinical trial and regulatory affairs expertise at the site and operations levels and contribute to the drug and medical devie development process. The program is designed for clinical research and regulatory staff who, as MCRRA graduates, will be prepared to fill senior, managerial and leadership positions in the field.