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Conducting pediatric oncology clinical trials: a coordinator’s perspective

May 10, 2019 Leave a Comment

Tatsiana Verstak interviews Kathy Jackson, CRA at St. Jude Children’s Research Hospital, Memphis, TN

Kathy Jackson has worked at St. Jude Children’s Research Hospital for 22 years, with 15 of those years in clinical research. Her background is in Health Information Management with a Master’s in Information Systems. She has had her Certified Clinical Research Professional (CCRP) certificate since 2006, and her primary research area is leukemia/lymphoma with a focus on pediatric acute myeloid leukemia (AML).

Tatsiana Verstak: Describe your job as a CRA at St. Jude.

Kathy Jackson: I have all my patients on all my studies and go through each one in Millie and review adverse events, medications that they’re taking, prophylactically or for treatment, and put everything into a database. Typically, physicians, PIs, want reports and so I’ll pull reports for them on those patients.

Presently, I work on mostly AML studies, one lymphoma study, a big AML study on the frontline, and then I have a couple relapse studies as well. Mostly I review charts and I pull out information then put it into a database for data collection for the PIs to run reports and do their final analysis to write their papers.

Tatsiana Verstak: I’ve heard that the term CRA at St. Jude could mean a coordinator or a monitor. Do you do both?

Kathy Jackson: I know that the job of the CRA and coordinator is different at St. Jude than in industry.  I’m basically a data manager as far as the CRA role goes. Just pulling information, that’s my CRA role.

Tatsiana Verstak: How did you get into this position?

Kathy Jackson: When I started at St. Jude, I had my bachelor’s degree in health information management. I started off in medical records. I was a co-analyst assigning ICD9, CM diagnostic and procedure codes. I did that here for seven years and I was getting kind of burned out with just doing the coding. So, I went back to school and got my Master’s degree in information technology. I had a friend who became a clinical research associate. I said to myself, “Well, I might want to look into doing that”, so I interviewed and that’s where I’ve been for the last 15 years, in clinical research.

Tatsiana Verstak: How long have you worked in oncology?

Kathy Jackson: Oncology is what I’ve been doing for the last 15 years.

Tatsiana Verstak: Do you feel that coordinating oncology trials is different than other therapeutic areas?

Kathy Jackson: I would have to think so because the treatments would be so different. It would be hard to go into endocrinology or something and do research studies on that because it would be so different than what I’m used to. The medications are different, just the basic biology of the diseases would be different.

Tatsiana Verstak: What kind of background do you need to become an oncology CRA?

Kathy Jackson: You need to have some kind of medical background, but you don’t necessarily need to be a nurse. I know we’ve hired people in who were in the laboratories– they know biology. I think it’s important to know anatomy and physiology just to understand how the disease process works.  In health information management we did have a nice balance of biology and management classes. I think that having a biology background helps with clinical research as far as having to read charts and understand adverse events. Is it the drug that caused this, what’s going on with this patient, is it just part of their disease or is it the medication that they’re receiving?

Tatsiana Verstak: Did you feel prepared when you started this position?

Kathy Jackson: I did not really know what to expect but I was lucky in that the woman who was leaving whose position I was taking was able to stay on for about a month. She showed me everything. She did the data management role, but she was also a research nurse. We’ve had some people come in and it’s like, “We got to throw you in and you’ve got to jump right in.” We’ve got a good group and the leukemia group that I’m with has been very helpful in teaching each other about different things.

Tatsiana Verstak: What changes have you seen in oncology trials over the last 15 years?

Kathy Jackson: I think over the years there’s been some more federal regulations that have surfaced, especially privacy and HIPAA and everything like that. We can’t have any patient identifiers, and you need to have a certain number and link patients up to their treatment group some other way. You can’t share information.

Also, the monitoring here at St. Jude was never lax, but it was just different. It seems like now they look at a lot of more specific areas. I think it helps everyone to stay in line and follow the protocol. The federal regulations have changed over the years, nothing really drastic but just making sure that patients’ privacy is maintained, definitely with the computer systems and databases.

When I started here you had to walk around and look at the charts. Nothing was on the computer. It’s helped as far as having everything right there at your fingertips pretty much, instead of taking the time to have to go away and review charts.

Tatsiana Verstak: What unique characteristics do you think that a person in your role should have?

Kathy Jackson: You need to be detail oriented because there are definitely specific things you have to look for. Time management, that goes for anything that you’re doing. You also mustn’t mind sitting at your desk for three or four hours at a time. You need to be open to change because things are constantly changing with technology. We have a good group of people and we don’t have a lot of turnover.

Tatsiana Verstak: Do you think that being certified helps?

Kathy Jackson: I definitely think that does help because every three years we have to be recertified. I don’t touch on everything. I don’t do consenting. It helps to kind of maintain the CITI* testing that we must do every couple of years. Staying current is very important because even though I don’t do every aspect of the clinical research it’s nice to be able to know that I understand how it works.

*CITI: Collaborative Institutional Training Initiative

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