Prerequisite: Overview of Drug Development; Good Clinical Practices, or related experience with program approval.
Each day a drug is delayed from reaching the market, the sponsor loses up to $8 million. Pharmaceutical, biotech and device companies are always looking to conduct clinical trials faster and more cost effectively. The Clinical Project Manager (CPM) is the main operations person leading the team charged with the day-to-day conduct of the clinical trial. This course examines how the CPM takes a clinical protocol and moves it through the start-up and conduct stages of a clinical trial. We will review several key processes including vendor selection, establishing study processes, selection and training of clinical investigator sites, regulatory and IRB submissions, management of drug supply, enrollment, data entry and monitoring.
This is a fully online class and meetings will be held weekly online using Zoom videoconference technology. Check the course schedule online for times.
You will have access to the class after registration and payment at: https://ilearn.sfsu.edu, by logging in using your SFSU ID and password.
|Dates||Days and Times||Location||Faculty|
|5/2/20-5/16/20||Sat, 11:00AM-2:00PM||Online||Michelle Gray|
Course fee: $495
|Refund Code||Full Refund||75% Refund||No Refund|
|CEL_1||Class dropped one day prior to class start day||N/A||Class dropped on or beyond class start day|
Last Update: Feb 14, 2020 9:37am