Regulatory Science Symposium: “Keys to a Clinical Trial: Management and Operations” Session 5 - Project Management: Managing Research Studies as Projects… How and Why? (2024)

Competencies: Project Management, Regulatory Science, Regulatory and Quality Sciences, Clinical Research, Clinical Trials

Course Syllabus/Topics:

1. Key Takeaways:
1. Clinical and translational research can be framed as projects handled in an organized way.
2. Highlight values and transferrable asset.
3. Careful planning and clear communication are key to any project’s success.
2. Defining Projects
1. A project is a temporary endeavor undertaken to create a unique product, service or result.
2. Project Management is the practice of using knowledge, skills, tools and techniques to complete a series of tasks to deliver value and achieve a desired outcome.
3. Project manager (PM) Role
1. Why learn PM? Growing recognition of value, growing labor force (+33%) and efficiency will translate to patient health.
2. High demand for PMs
3. PM skills (highly transferable skill set):
1. Management
2. Problem solving
3. Communication
4. Organization
4. Other roles: mediator, cheerleader, pinch hitter (be able to stand-in if needed and qualified), secretary, Johnny on the spot (resourceful, know where to locate information)

1. Methodologies
1. Project Phases
1. Initiate: capture requirements, documentation
2. Plan: define scope, assign roles, deciding timeline, project charter approved (shared and measurable expectations)
3. Execute: Implement and Monitor (tasks, e.g., IRB Approval, Recruitment, Monitoring)
4. Close: New way of working, lessons learned captured
2. What makes a good milestone?
1. A task of zero duration/ point in time – something is achieved
2. Important achievement/ signifier of change
3. Signposts/sequence of events
3. Constraints-The Iron Triangle
1. Time; how long it will take
2. Budget; how much it will cost
3. Scope; what will be included
4. Scope creep; new ideas or tasks, stretch project resources
5. Jargon
2. Tools
1. Monday.com
2. Google Drive
3. SC CTSI Project Management Charter
3. Discussion
1. What are common scope creep issues in research? Ideas for addressing them?
4. Key Takeaways
5. Thank you!
   

Acknowledgements
Accompanying text created by:
Roxy Terteryan, Project Administrator, SC CTSI (atertery@usc.edu)
Rushaanaaz Sokeechand, Student Worker