June 20, 2011
Oversees and manages the centralized reporting process for serious adverse events (SAEs) for oncology research trials. Responsibilities include: provides consultation regarding SAEs, monitors electronic reporting and follow-up actions, maintains SAE data in the Group database, coordinates with the Physician Evaluator and prepares and reviews various reports including safety reporting to the FDA, when applicable.
Also responsible for conducting quality assurance audits according to National Cancer Institute (NCI) and Good Clinical Practice (GCP) guidelines. ...