Hello and welcome to the Certified Good Clinical Practice Manager Course.
I'm delighted to join you on this journey to deepen your understanding of ethical and scientific standards
that govern clinical research. My name is Jennifer Lai, I'll be the faculty leader on this course.
My background: I have a biology background with an MBA and a doctorate in health
administration. I did a postdoctoral fellowship in clinical research ethics.
I have over 25 years of experience in the pharmaceutical industry in clinical data management and
clinical operations. My roles have spanned from data analyst to CRA to VP
of clinical operations. I've worked on studies from phase one through
three in a array of indications and I do practice GCP daily in my work.
This course will be structured in 10 comprehensive modules consisting of three focused lessons
each about 20 minutes. Throughout the program we will explore key principles of GCP,
including regulatory frameworks, trial design, informed consent, data integrity, safety
monitoring, and stakeholder responsibility. Whether you're new to research or using
this course as a refresher, the course was designed to support learning and practical applications.
Please feel free to reach out to me at jlai.clinical@gmail.com if you have any questions or
feedback along the way. See you in the Lesson 1!