“A Day in the Work-life of an SRAI Member” Series | The Trials of a Clinical Trials Office

by Tonya Edvalson on Thursday, December 21, 2017

I come to SRAI with a bit of a different perspective sometimes it seems. I work as a regulatory coordinator. I submit IRB applications, educate our research staff on Good Clinical Practice, research ethics, help investigators develop their protocols, etc. My role comes along with the element of ensuring compliance to federal regulations and internal policies. I have come to learn more about the entire operation of a clinical trials operation, particularly over the past ten years or so. I’ve asked the question in my mind several times over, “How does what I do impact research administrators?”  It turns out – quite a lot.

Budgets are quite important. I get it. If we don’t have the money, we don’t get to employ the staff and do the research that we all want to do. I also know that if we don’t do it right, the ramifications can be quite expensive and we could lose all the money and the reputations that we have built along the way. Reconciling that as a team can become quite a challenge sometimes. 

I have enjoyed the new perspective of accepting how it all fits together. When we are creating budgets, we now take into account that, no matter what some investigators think, consent doesn’t just take a “few minutes.” It takes time and budgeting that time is important to meet the standards we want for good, sound, and ethical research as well as financially solvent research. Thinking about things that come along the way: patient care costs (what is standard of care really?), monitoring visits, translation costs, patient education materials, etc. for each individual project is important so we aren’t surprised by these costs later. 

Education of our staff takes time, resources, and funds. I don’t believe that research teams get up and decide to make mistakes or do things incorrectly. They inherently want to do things well, they just don’t always have the tools or knowledge.  Providing those tools is important for a compliant program. Non-compliance can make or break a program. This is now considered when we prepare our budgets. 

I have come to better appreciate the challenges that my financially-minded colleagues face. It helps me to be creative in how we can operationalize processes so that they are mainstreamed into the day-to-day operations and processes. This helps on many levels.  We can be sure that we doing what we need to do, but as efficiently as possible. They become part of our accepted practice and less likely to be missed. 

I know that when we all sit down together and consider the bigger picture of both sides, it improves our program and gets us closer to our goal of helping moms and babies all over the world. It’s a modest goal, I know. 

Authored by:
Tonya Edvalson
Immediate Past President, Western Section
Regulatory Coordinator
Intermountain Healthcare

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