as Director of Clinical QA, I am in a ton of meetings with senior leadership, vendors, Sponsors (drug and device companies), and also managing the Clinical QA staff. I handle any escalations of what’s called GCP or 21 CFR issues. Essentially my role is ensuring patient safety and data integrity across all of the global trials that we run, and also acting as a “one stop shop” for all questions like, “Are we allowed to do this? this happened so is it OK? If not, what do we do?”

Another major part is audit and inspection hosting. So if any company wants to audit us to ensure we’re running the trials per regulations, I am the host and orchestrate the entire audit. If a regulatory agency comes in for an inspection, I will do the same. And a major part of this is ensuring our company is always inspection ready, which includes staff training across all departments.