Site Management & Regulatory Affairs
Streamline operations and master regulatory processes
LEVELS
Training Levels
Choose the right level for your team
Fundamentals
LEVEL 1New coordinators, junior CRAs, research nurses
- Essential documents (ISF) maintenance
- IRB/EC submission packages
- Site set-up (SIV)
Professional
LEVEL 2Experienced coordinators
- Managing monitoring visits (SQV to COV)
- Handling protocol amendments
- Adverse event reporting workflows
- Patient retention
Strategic
LEVEL 3CRU directors, site PIs
- Business development for research sites
- Negotiating Clinical Trial Agreements
- SOP development
- Inspection leadership
OUTCOMES
Learning Outcomes
Streamline daily site operations for multiple concurrent trials
Master SFDA and local ethics committee submission processes
Maintain constant state of readiness for audits and inspections
Improve site budgeting and contract negotiation
Build and manage high-performing research teams
AVAILABILITY
Training Formats
On-Site Training (KSA)
CERTIFICATE INCLUDED
Virtual Classroom
CERTIFICATE INCLUDED
Europe Immersion
CERTIFICATE INCLUDED
All participants receive an MFG Training certified completion certificate upon successful program completion.
Key Topics
Key Topics
- 1Essential Documents (ISF) Maintenance & IRB/EC Submissions
- 2Managing Monitoring Visits (SQV to COV) & Protocol Amendments
- 3Adverse Event Reporting Workflows & Patient Retention
- 4Clinical Trial Agreements (CTAs), SOP Development, & Inspection Leadership
Not Sure Where to Start?
Assess your team's experience levels and exact training needs with a customized consultation.
- Level Recommendations
- Customized Proposals
- Flexible Scheduling