Overseeing Multi-Center Clinical Trials

I’d like to introduce you to Holly Davis, the UVA employee I’ve known the longest. That’s because she’s my cousin. We grew up like brother and sister in far Southwest Virginia, and we have the accent to prove it. I can recall going to see Holly at the hospital when she was born; now she has two little ones of her own. Like me, she first came to UVA as an undergrad. Since then, she’s held a variety of jobs here, starting out working in a lab before becoming a clinical trial coordinator at UVA Cancer Center. She’s now a project associate overseeing multi-center clinical trials. She tells us a little bit about what she does:

So what do you do?

If a UVA investigator comes up with a concept, or perhaps they’re approached for collaboration by a funding source, they develop a protocol for a clinical trial. If they want to make it multi-center, meaning they’re going to enroll [trial participants] at multiple institutions or hospitals, then we are brought on to manage that, the multicenter aspect of it. So if you have a clinical trial that’s just enrolling at UVA, that would not hit our office. But if someone who has a clinical trial that’s already opened here decides that they want to have other sites participate, or if [the trial is] written with it in mind that it will be multi-site, then that’s when we become involved.

What’s involved in coordinating a multi-site trial?

We check feasibility of sites to participate and do study startup and then we manage the overall conduct of the study for all the sites involved. So reviewing subject eligibility, to see if they’re eligible; randomization, if need be; doing the regulatory side; doing data and safety monitoring, quality assurance, that sort of thing. From study initiation at the other sites throughout the life of the study to final close-out, we manage all that.

How many are you managing?

Currently I manage six studies open at 19 sites, I have four sites that are in process of opening, and one closing. And then at any given time, there’s two or three that are still in the proposal phase.

What’s the hardest part of the job?

Managing all those different pieces. So it’s a lot of multitasking, because you have to do a lot of different projects all at once that require you to bounce back and forth.

What’s the most rewarding part?

I think it’s important work. It’s interesting. It’s not monotonous because you’re bouncing back and forth. And it’s nice as you reach the end to actually see all the work come to fruition, especially if there’s a good result.

Thank you, cousin Holly!