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The Clinical Research Professional: Intro to a New Series

Hello everyone! I am so excited to tell you about a new series coming to SennSays that is entirely dedicated to the clinical research workforce and our professionalization. This series is going to be as much intended for people who are not yet in the industry and who want to be, as it is for people who are already in it, and every level of where you are in it. I'd like to start by telling a story about what hit me about a decade ago that made me so passionate about this. It is, of course, my focus for this year as the ACRP Chair in 2023, because I always want to have a purpose that I'm pushing forward – and I'm so excited that the Executive Director and the Board of Trustees are on board with this as well.

About a decade ago I was at an ACRP conference where I heard Terry Hinkley, who is an RN, and Jeff Kingsley presenting about the professionalization of the nursing profession. The idea was that people now choose nursing as a career and there are set levels of competencies, and you get to a certain level of competency and training. You take a test and you are now an LPN and if you keep going and you can become an RN, you can become an NP (a nurse practitioner), you can become a Doctor of Nursing (a DNP). There are several levels of nursing and you can see that they've been growing over the years as the professionalization has continued and expanded.

There is no reason this could not happen in clinical research. It really needs to in a lot of ways because it is very difficult to employ people in clinical research who have any experience or training. That's because there just are not many training programs available. It's not a degree that people get at most schools. There are to be some examples where I'm wrong, where things are coming along, which is fantastic, but a lot of us fell into clinical research.

How do we get people interested in clinical research as an actual career, and then professionalize it beyond getting them interested? For example, a person who has one year in clinical research is certainly not the same level of training and knowledge as a person who has 20 or 25 years, correct? There are distinctions that could be made there. Also, how does it affect financials? I know a lot of people like to think about that. If a sponsor is hiring a clinical research site, for example, and the lead person on their trial is a clinical research coordinator who is a certified clinical research coordinator by ACRP, or has other certain certifications, then wouldn't that deserve something more? Because you already know from research that's been done that the protocol deviations will be lower, and patient recruitment should be higher, as well as understanding the consent process. That person is going to require less effort to train them as a CRA, you just have to train them on the protocol, and you can feel a lot better about the monitoring being done. All of this is so important for the data we give to the FDA and that is how we protect our patients, right? That's how we protect the world. The FDA is relying on the rest of the people in the clinical research industry to do a really good job and the professionalization of a clinical research professional does just that.

In this series, we're going to start with Susan Landis, who's the Executive Director of ACRP, to explain the workforce problem with some definitive stats and what she and others are doing to help combat that, so that we can get to this place where we develop a stronger workforce coming up and then developing through their whole career. I will have other interviews as well. Some will be from the clinical research site perspective, both how to hire a good coordinator (CRC) and how to make yourself appealing to an HR person if you want to become a coordinator. I'll also be talking to someone who owns a CRA staffing agency. We're going to talk to someone with the IRB (Institutional Review Board) because that's a job that people don't often think about, which is on the ethics side. Very important work goes into making sure that a protocol is sound and what might need to change so that it's protecting the patient when it comes to writing the informed consent forms.

We also have a lot of technology, and it's another part of what we do, which is a huge help to the clinical research industry. It helps us get off paper, for example, which makes us able to be monitored from anywhere in the world. It could help us from making major protocol deviations and even minor ones. And there are many other things such as artificial intelligence that could help with patient recruitment.

We’re going to talk to a lot of people in this series. If you are not yet in the industry and you want to hear an overview of what some of these types of clinical research companies are, I'm going to start that section right now because it's going to help you a lot as we go through.

[Next in series: A Primer on the Clinical Research Industry]

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