What services does the UVA School of Medicine Clinical Trials Office provide to faculty?
Amy Warren, MS, CCRC, Protocol Development Administrator, Clinical Trials Office, answers that question and more.
This post is part of a series of interviews with faculty and staff who offer resources to SOM faculty. Stay tuned for more interviews with your colleagues!
Q: Can you tell us about the services the Clinical Trials Office offers to faculty?
The Clinical Trials Office is an umbrella group for all of the departments in the School of Medicine. We provide assistance from the beginning to the end of clinical trials.
We help with FDA audits. If an FDA auditor comes in, we help set up the space for them and tell the principal investigator what to expect in the audit.
We also have a team that helps investigators who want to set up multi-site trials. Right now, that’s primarily the Cancer Center. They have a lot of cancer studies, and if they want to go to another site and start recruiting patients there, there are a lot of regulatory issues, which our office can help with.
Another big aspect of the office is providing budget assistance. When you have clinical trials, they are billed under a grant, and we have a couple of individuals who help set up that billing pipeline, which keeps everything billed properly.
The CTO also helps investigators start their studies by writing protocols and helping them with the statistics and getting everything on paper and through the IRB.
We are working on rolling out a new clinical trials management system, called OnCore, which we hope will be ready later this year. It’s a computer program that the Cancer Center is already using, and now all investigators will be using it.
Q: How long have you been at UVA?
I did my undergraduate at UVA. I’ve worked at UVA since August 2013. I left for a while and never thought I’d come back. I moved to Houston; I really liked big cities. But my husband got his dream job here, so we moved, and I fell in love with Charlottesville again.
Q: When you were younger, what did you want to be when you grew up?
I wanted to be a scientist. I got a master’s in genetics and took this turn to clinical research. I’m doing what I wanted to do.
Q: Do you have any children or fur babies at home that you’d like to tell us about?
I have three children and two dogs.
Q: Do you have a favorite local restaurant or hangout spot here in Charlottesville?
With kids, I don’t get out that much! We like to go to our neighborhood park.