Premier Episode of On Research Podcast – What is a Clinical Research Associate?

Darren Gaddis: From CITI Program, I’m Darren Gaddis and this is On Research. Today, what is the difference between a clinical research associate and a clinical research professional? The skills and training needed to be a clinical research associate and general misconceptions about clinical research associates. I spoke with Elizabeth Waddell, owner and CEO of the CRA Helper.

She has been in the clinical research industry for over 20 years. Elizabeth began her career as an in-house clinical research associate and later transitioned to an on-site clinical research associate. After 14 years as a monitor, she transitioned from a senior clinical research associate to a line manager role focused on training new CRAs.

As a reminder, this podcast is for educational purposes only. It is not intended to provide legal advice or guidance. You should consult with your organization’s attorneys if you have questions or concerns about relevant laws and regulations discussed in this podcast. Additionally, the views expressed in this podcast are solely those of the presenter.

Hi Elizabeth. Thank you for joining me today.

Elizabeth Waddell: Hi Darren. Thank you so much for having me. I’m excited to be here.

Darren Gaddis: To get us started, what is a clinical research associate or CRA?

Elizabeth Waddell: So a clinical research associate, like you said, A CRA, and they’re also known as a monitor. I think the best way to explain what it is, is to start with why is it even required.

So per FDA regulations and GCPs, the sponsor must ensure that the clinical trials are properly monitored and this is to ensure the rights and the wellbeing of the human participants are protected, and they have to make sure the patients are safe. And on the flip side, they need to make sure, and ensure that the data from the clinical trial is accurate, complete and verifiable from source documents. And that the study’s being conducted in compliance with the protocol GCPs and reg requirements. So there’s a lot they have to monitor in a trial and that’s where we come in, that’s where the CRAs come in.

We must monitor the studies on behalf of the sponsor. And our two major obligations are ensuring subject safety and data integrity. And there’s even guidance regarding the selection of CRAs, as we must be qualified by the training and experience to monitor the progress of the trial. So it’s a very important role, as keeping patients safe and protected is so huge. And also verifying the validity of the data is huge, because for example, in a pharmaceutical trial, the FDA is reviewing this data to evaluate if a drug is safe. They’re evaluating if the drug is effective and that’s going to go into all that decision-making if a drug is approved or not. So it’s very important, monitoring the progress of a trial.

Darren Gaddis: And from that definition, what is the difference between a clinical research associate and clinical research professional?

Elizabeth Waddell: So a clinical research professional to me, is anyone in the clinical research industry. So a CRA would be an example of a clinical research professional. It’s one of the roles in the industry. There are so many roles as you’ll see from project managers to auditors to clinical trial associates, and then you have roles at the site level as well.

Darren Gaddis: From your own experience, could you describe the training and skills that one needs, to be successful as a CRA ?

Elizabeth Waddell: So I’ll start with the training. When we would review CVs, a curriculum vitae, it’s like a resume in the research world. When we would review CVS in order to interview a potential CRA candidate, we primarily looked at their education, as well as their clinical research experience.

So taking a CRA training per se, wasn’t something that was required. Again, we focused on the clinical research experience. Now, although a CRA training course is not required though, can it help build confidence? Absolutely.

So for example, when I was assigned to a study that was a new therapeutic area, in addition to training at our company, I would take extra trainings to build confidence when monitoring the disease under study. So it’s the same thing with a CRA training course that may not be a requirement to get the job, but if it can help you learn and build the confidence to perform the job better or even interview better, it is so worth it.

And the same thing, even certification being a certified CRA, it wasn’t necessarily a requirement for me, I didn’t have to be certified and actually I did my certification, or obtained it when I was a senior CRA.

My company offered, they were like, “Hey, we’ll pay for it, you have the time. Do you want to go for it?” And I’m like, “Oh my gosh, yeah that would be awesome!” So I did do it, and it’s an accomplishment for sure, and I’m glad to have it and I’m glad to have the credentials. But did I have to be certified to get a CRA job? I did not. So I do like to point that out. Definitely, clinical research experience on a CV speaks volumes, but again, you do the training more for yourself to help build that confidence.

As far as skills required, definitely, attention to detail. You will go through documents like a fine tooth comb, you definitely need to have those eagle eyes, attention to detail, and definitely critical thinking skills, because in research you’ll find that not a lot of things are black and white. It takes critical thinking, problem-solving, sometimes escalating things to different study team members.

I’ve been in research for 20 plus years and I still send emails like, “Hey, I’ve noticed this. This is what I’m thinking of, how to resolve the issue, what are your thoughts?”

And sometimes you have to consult with different departments. Not being afraid. Do not be afraid to ask questions. Again, like I talked about, you’re going to confirm things with different departments sometimes. And to me, asking questions is not a sign of weakness, it’s a sign of strength, because you want to do your job, you want to confirm things for your study.

And you definitely need to have time management skills, there are a lot of deadlines and metrics that you must meet, so definitely time management, being able to prioritize, and then being able to reprioritize, because there’s many times things are changing in clinical research, you may get an email that totally changes your day. So you’ll have to reprioritize what needs to be performed for that day. And like I mentioned, being able to adapt, being flexible, so these are some soft skills that you’ll need to have as well, as deal with different personalities.

Very important, as you’ll be not only with your study team, but you’re going to be going to many different sites and interacting with different people and things, so that’s important to have as well as being able to be organized, being able to work independently because again, you’re going to many sites working by yourself there, monitoring documents, as well as sometimes when you’re not on the road, you may be working remotely, at home in your office.

So you have to be able to still meet your deliverables, work independently and be able to communicate effectively. And not just verbally, but written communications is very important. Lots of trip report completion, email communication, lots of documentation as a CRA, so definitely written communication is so important. And I know there are many more skills I could probably point out, but I would say this is a good start of important skills to have.

Darren Gaddis: And with all of this in mind, would you be willing to share your own journey to becoming A CRA ?

Elizabeth Waddell: Yeah, sure. I graduated with a bachelor’s in clinical research, and while I was doing my internship, I interviewed to work in the lab actually, at a company that manufactured vaccines. And I was offered the job, but at the same time I received a call from a recruiter with an opportunity as an entry level in-house CRA, and I was like, “Oh wow, this is clinical research…”

My heart was just being tugged in that direction, and it ended up that I chose the in-house CRA opportunity and it was definitely a blessing. I first was contract, then I went permanent, and after about a year of being an in-house CRA, a CRA 1, I was promoted to a CRA 2, and then moved to the clinical department and started onsite monitoring. And the rest is history, here we are 20 years later.

Darren Gaddis: And from your own tenure, what is one general misconception about CRAs?

Elizabeth Waddell: In my experience, I would say one of the misconceptions about CRAs I would see, is people would picture, “Okay, CRAs, they come to a site and their role is to go to the site and pick them apart.”

And although sometimes I would, I’d be at a site and I’d see another monitor come in, and maybe they would have this air about them, like high and mighty. And they wouldn’t nicely point out issues that they observe. Sometimes that happens…

But the truth is we are a team with the site. So even though I may go to a site and I’m monitoring the study and I’m reviewing charts and reg docs and study drugs… And yes, I may discover or observe an issue, there’s a way that we treat our sites, and a respectful way to point out observations and also reeducate them because we want to help them, we’re there to help.

We also should work together with a site as a team, having that same goal of subject safety and data integrity. So that’s definitely a misconception that people have because there’s not one role that’s higher than the other. You have the site level and then you have a CRA that’s either with a sponsor or a CRO, and again, we’re all a team doing this clinical trial together.

Darren Gaddis: How could someone get their start as a CRA?

Elizabeth Waddell: Well, most CRA positions require at least a bachelor’s degree and usually in a scientific area or a scientific discipline is preferred. This of course would depend on the company. In addition, most entry level CRA roles require about one to three years of clinical research experience. Again, that’s going to depend on the company, but clinical research experience, like I mentioned, speaks volumes on a CV, so some ways that people may gain this experience in order to apply for an entry level CRA position, they can gain this clinical research experience like me, maybe starting out as an entry level in-house CRA, and then move to onsite monitoring. Or they may gain experience as a clinical trial associate or a project specialist or project coordinator. And some may gain experience at the site level, as a research assistant, or a clinical research coordinator, and they’re also known as a study coordinator.

And I always say that in my experience, study coordinators make great CRAs. So some people gain experience that way, and others may start with even a clinical research internship and start getting that experience under their belt that way. So unless a company has a position where they have their own training program and they do not require previous research experience, which there’s not many that I’ve seen, most of the time the companies will require at least one to three years of that previous clinical research experience. So it’s definitely important to have clinical research experience under your belt.

Darren Gaddis: And what else would you like to share with us about CRAs?

Elizabeth Waddell: Clinical research is a blessing, and to be a part of, and being a clinical research monitor, CRA is so rewarding. And also there are so many roles that it can lead to in the industry, like becoming a lead CRA or project manager, or even if you want to manage CRAs like becoming a line manager or QA auditor, or like me managing and training new CRAs, which I absolutely love. So there is so much growth in the industry. So that’s another great thing about it.

Darren Gaddis: Elizabeth, thank you for joining me today. Be sure to follow, like and subscribe to On Research with CITI Program to stay in the know.

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