A brief chat with the regulatory research support specialist
Monday, December 3, 2012

So what do you do here?

I’m a regulatory research support specialist. That means I’m the main point of contact for the Clinical and Translational Science Research Core that handles the study startup process for the trials. I work on budget negotiations with corporate sponsors, and then I figure what our expenses are to conduct a trial here. I also handle IRB submissions, internal committee submissions, and regulatory documentation from sponsors. And I track the studies financially once they are open to enrollment of study participants. Our goal is to provide efficient clinical trial regulatory services and to be experts in our field. We’re really like the frontline in getting a clinical trial started, doing it efficiently and meeting deadlines.

Right now we have more NIH-sponsored studies but we’re definitely starting to get more corporate-sponsored studies. Corporations are attracted to credible institutions with significant patient populations. If they know we have the patient population for a study, they want to work with us because we’re a large institution with great resources for operating clinical trials. Then, of course, studies that are successful and meet enrollment expectations lead to a publication. That’s what attracts more funding to conduct trials — the potential to publish significant findings.

What do you like most about working in a higher education setting?

Watching the different trials and publications that come in and out is interesting. It’s rewarding when you help with a successful trial that becomes noticed. It wouldn’t happen without all of us working together as a team.

What’s the biggest risk you’ve ever taken, and did it pay off?

When people think of risks, they often think of money. But I would say the biggest risk I take is being honest — with my superiors, supervisors, administrators, and so on. A lot of people probably aren’t completely honest with their opinions, thoughts, or suggestions because they are scared of the response they will get.

There are also risks in terms of investment — the ICTS as an institution invests time and funding into clinical trial resources for investigators and the University to produce successful clinical trials. Sometimes it can be difficult to forecast the success of the trial and if the benefits of the trial will outweigh the risk of the investment.

If you could get rid of one invention in the world, what would you choose?

Fast food! That seems to be one of our nation’s biggest struggles right now. Fast food has a lot to do with our nation’s obesity issues, which causes a lot of health issues today and is the reason why we have these expensive medical facilities and increasing health care costs.

List five of your favorite things:

  • Bicycling
  • Herbalife, a nutrition product line
  • Boating, especially on the Mississippi River and visiting towns and restaurants near the docks.
  • Fundraising events
  • Exercise