This course presents the effective planning and management of drugs and biologics clinical research trials. Exercises and case studies will illustrate how to develop and manage activities, timelines and budgets; examine staffing and resource requirements; and lead and motivate effective teams. Strategic clinical development plans, team and clinical site performance problems are also discussed.

This course will benefit clinical research professionals who are planning to begin or like to manage clinical research studies.

Skills Needed

• To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and essential understanding of Canvas.
• Working knowledge of MS Word, MS Excel, PowerPoint, and Outlook
• Highly organized and able to handle multiple tasks and work well with others
• Broad educational background with courses in computers and public health science management.
• Completion of a general course in the content area of Clinical Research, or 2 years of experience in the Clinical Research workplace.

Learning Outcomes

At the conclusion of the course, you should be able to

• Describe critical elements of a clinical trial projects, methods of project management and documentation
• Discuss role of a clinical trial manager and/or clinical project manager, and strategies of risk assessment and mitigation
• Discuss Clinical Trial Management Planning (Budgeting & Timeline)
• Identify pathways and resources needed for successful clinical research trials, and tools of project management

Topics Include

• Project development and management
• Building a Quality Management Plan
• How/Why Clinical Trial fails?
• Using Metrics to improve trial management

Notes

CA BRN/LVN Credit--Provider #CEP13114, 20.0 Hours.