Strategies for planning and managing clinical trials, including operational complexities in clinical research projects are examined. Effective methods used for the preparation of scientific documents, data management, quality assurance, safety reporting, and end of trial practices are explored. Students will also apply real-world skills of leadership, project management, and risk management in clinical research. Pre-requisite: ACR 103 Clinical Trial Design.
No Scheduled Class Meetings, January 15 - April 7 (Online)
Location:
ONLINE
Instructor:
Lawrence Reiter
Notes:
Synchronous Webinars scheduled three times per term. Webinar dates will be posted at the start of the term and will be recorded. Please note registering after the course start date may delay course access and does not permit exceptions to coursework due dates, late textbook purchases, or the refund policy
Instructors
Lawrence Reiter
Lawrence Reiter has almost 20 years’ experience in the Pharmaceutical Research Industry in Clinical Operations, Project Management, Quality Assurance and Compliance. His experience includes monitoring and project management across a wide variety of therapeutic areas to include drug and device studies across all phases.
Lawrence has worked in multiple regions around the world and manages global studies in over 40 countries. In addition, he is accredited by and remains in good standing with the Society for Quality Assurance as a Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP).
Lawrence is an experienced lecturer in GCP having been directly involved in the setup and running of a non-profit training organization in South Africa that provided training across global regions to both Sponsor and site staff.
