My Opinion: CRCs, CRAs, and CTMs Have It Tough

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as if Dan ShellChief Editor, Clinical Lead

Tiffany Ashton_450x300
Tiffany Ashton, MAS, CCRA

Full disclosure: My background is not in clinical trials. Of course, I’ve worked primarily on pharma-related content for the past 14 years, but I’ve never really identified in one part or stage of the drug development continuum. So, I’m stepping into this new position as Editor-in-Chief. Clinical leader, I always appreciate people who take my time on some of the ins and outs of the industry, like Tiffany Ashton, MAS, CCRA. In this case, Ashton, director of operations at ClinEssentials, shares some insights from her 20+ years working as a CRC, CRA, clinical trial manager and project manager. “I started as a CRC and worked my way up the ranks,” she begins. “So, ‘Hey, what is this and how does it relate to all this stuff?’ I know what it’s like to be that person. I am proud to be able to give a quick overview. [of a clinical trial-related topic] So one can understand exactly what we in the industry are talking about – because otherwise you will get lost in the weeds.

The following quotes demonstrate Ashton’s expertise (and patience) in successfully navigating me through my newfound questions related to the roles of CRCs, CRAs and CTMs. I came away with a newfound respect for the people who strive to make these acronyms their business, and a better understanding of why there is such a talent shortage in this industry.

(The following has been edited for clarity)

Dan Shell:

How important is being a CRA to CTM? Does this make a difference? I mean, obviously you can be a CTA and then transition to a CTM without experiencing the life of a CRA road warrior.

Tiffany Ashton:

It’s for a reason. [good to be a CRA before being a CTM], but not mandatory. So for example, it makes you more thorough and sympathetic to the CRA. It helps you understand what CRAs face and the challenges they face when they’re out on the road. So, just when you think they have time to do all the things you ask, they’re bound to be stressed because they’re running through the airport due to a change of lane or their bag didn’t work. is it. Or, they’re driving through new cities and have bad weather for the trip, then when they get there they have eight hours to do the laundry list they know they need to do. Plus, the unexpected always comes up.

Therefore, having a CRA background will help you gain more empathy as a CTM, and can help you rethink unrealistic questions while taking into account all the things you’ll encounter along the way.

Dan Shell:

You previously mentioned CRAs traveling 10 days a month. Is that normal and means 10 sites in a month?

Tiffany Ashton:

On average, there are 20 working days in a month. Typically, companies require CRAs to be on site eight to 10 days out of 20 business days. That does not include traveling to and from assigned locations. Follow-up cycles are usually every four to six weeks. This means that you are rotating between all of your assigned sites every four to six weeks. Some top subscribers may request more than one day on site, so you won’t be able to visit 10 different sites in a month. Let’s say I hit all my Utah sites the first week of the month. Technically, I don’t need to go check out all of these sites until next month, which coincides with my follow-up period of visiting a site every four to six weeks. So a functional CRA will make their visit more productive than flying between states in a week.

And Shell:

Explain different stages of CRA.

Tiffany Ashton:

It usually goes CRA I, CRA II, and then Senior CRA. A Senior CRA is usually someone with four years of experience as a CRA, and this is the level of CRA most companies seek. They accept CRA IIs with two to three years of experience. Unless it’s a very simple study like Step 4, you’re usually worried about bringing CRA I to the team. After all, there is a learning curve to the CRA role, and depending on your previous experience, you may not have had a CRA at startup, maintenance, or closed in your previous role. So if they enter an environment that is strange to them and they don’t know what to do, they can make a lot of mistakes. When CRA is not robust, there are many misleading results, especially in complex studies. Level 4 studies are the best type for new CRAs.

And Shell: You have a master’s degree in clinical research from the University of California, San Diego (UCSD). Are there university-based programs to become a CRA?

Tiffany Ashton:

No Masters in Clinical Research Associate (CRA). There is a master’s in clinical research or clinical research management, but not in the CRA role. That’s why our industry needs training programs that teach what they need to know. For any role – CRC, CRA, CTA, CTM – are often thrown in. Don’t go into one of these careers. keep out Any formal training unless you join a bridge program ie the sponsor or CRO trains you for three months and you are shadowed for three months. Other than that, assume you’ll just get SOPs, some systems training, education on protocol and how to complete your timesheet – and then you’ll be put to work.

And Shell: You recently traveled all over the world and spoke to various clinical research experts. One of the things that surprised me is that you said that even in other countries, many websites are still using paper for many of their tests. Why do you think this happened? Why hasn’t there been more technology adoption in the industry?

Tiffany Ashton:

I think our industry is very slow to change – for whatever reason. We are fast in drug development but slow in changing processes. For example, when I started 20 years ago, they said that in 10 years we will all be electronic in clinical trials (in 2013). All electronic medical records, source, everything. Twenty years later, we still do about 80% on paper. So, although it makes sense, a lot of things are moving so fast, especially at sites, that the industry can’t afford to take the time to put a new process in place or adapt to something new. You have to keep rolling with it, even if it doesn’t have much efficiency. You don’t have time to spare to learn a whole new system or way of doing things.

Dan Shell:

Sure, I get it. It’s not like there’s a shortage of technology vendors offering innovative solutions for every phase or aspect of testing. But weeding through all those choices, much less knowing all the options, a Big Work! And then there’s the single sign controversy where everyone overcomplicates things about that.

Tiffany Ashton:

Consider that study coordinators are typically working on an average of at least five studies. If each study has five different providers, that’s 25 different providers in the studies they have. One of the biggest challenges is remembering the URLs and associated passwords for each system and study!

Some tech companies are trying to integrate with other tech companies to create a single login, where you can access 15 different companies’ products in one login. The problem is that each study is different, so if one or two studies are using a single sign for many vendors, chances are, the other three studies are the study coordinators who work directly with many vendors. Study coordinators need to go with the flow of what the study group is presenting in order to continue their studies.

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