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  • Role-Based Training
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Role-Based Training

Our role-based courses are designed to prepare anyone who is new to clinical research or transitioning to a new position, such as a monitor or research coordinator, for the specific responsibilities involved.

These courses begin with an overview of each position and foundational courses in the regulations that form the basis of every clinical trial. The role-based courses will fully prepare you to succeed and see your site’s research through to approval. It will give you the confidence to answer even the most challenging questions from other research professionals and inspectors.

Our role-based packages are specifically tailored to train:

  • New research coordinators
  • New monitors
  • Project Managers (Coming soon!)
  • Investigators (Coming soon!)
  • IRB Members (Coming soon!)
  • Formal training rooted in regulations
  • Anyone who needs a refresher course

Training Packages

Our training packages are structured around several disciplines critical to clinical research compliance, including anintroduction to good clinical practice, basic and advanced monitoring courses and FDA inspection preparation.

They’ll provide you with a solid foundation for understanding the regulations and why they’re so critical to protecting your subjects and ensuring compliance.

Our training packages include:

  • The Foundation Package
  • The Monitoring 101 Package
  • The Monitoring 102 Package
  • FDA Inspection Preparation Package (Coming soon!)
  • A customized combination of courses tailored to your needs

Individual Courses

Our individual courses give you the flexibility to choose your area of interest and learn at your own pace.

They’re a great way to obtain contact hours or advance your knowledge of the areas that interest you most. Because our courses are taught by clinical research professionals who come from a broad range of specialty areas and frequently spend time in the field, they bring a unique perspective to each topic.

Some of our individual courses include:

  • Introduction to the FDA Regulations Part I: 21 CFR Parts 312 and 812
  • Introduction to the FDA Regulations Part II: 21 CFR Parts 50, 56, 54, and 11
  • Introduction to Good Clinical Practice
  • Introduction to HIPAA and HITECH

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Strongsville, Ohio 44149
Phone: 440.801.1540

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