What does a typical working day look like for a CRA?
As a CRA, I usually perform several site visits during the week. Sometimes these visits are conducted remotely via a phone call or video conference meeting. When a new study starts, for example, I need to discuss with several sites whether they are able to conduct the study. If this seems to be the case, I perform a site selection visit in which we discuss what the clinical study will look like and afterwards I write a report about our meeting. If the site decides to proceed, I perform an initiation visit in which topics like the study protocol, requirements, legislation, safety training, and systems are addressed. Once a site is activated and the study has started, I visit the site multiple times to discuss with the study team how things are going and to verify that the patient data that are entered into the hospital records match with the data that are entered into our systems. Finally, at the end of a study, I perform a closeout visit too.
Furthermore, I am also the first contact person for participating hospitals and general practitioners. In between the site visits, I, therefore, have regular contact with study sites to address questions that they may have. In addition, I spend a lot of time collecting clinical study documents, I have regular meetings with our project team or I am updating our clinical study databases.
How is this different from your previous job as a CTA?
When I was a CTA, I spent a lot of time filing, documenting and doing quality checks on documents that were uploaded by CRAs. For example, I needed to make sure that forms were filled and signed correctly. In addition, I assisted CRAs and PMs by creating minutes of internal project meetings. As CTA you are assisting many different functions (PM, Clinical Team Lead (CTL), CRA), whereas as a CRA you have one main point of contact, which is the CTL or PM. As a CRA you have contact with the research sites directly, which is mostly not the case for a CTA.
Do you have to travel a lot for your job as a CRA?
Personally, I am mainly involved with studies that are executed within the Netherlands and therefore I don’t have to travel that much. But it really depends; at Julius Clinical, some CRAs travel a lot, especially if studies are being executed in several European countries.
What is your favourite part of the job?
I like to support sites with questions they may encounter, so together we can make sure that the clinical trial is executed in the best way possible.
What is the company culture like at Julius Clinical?
In my opinion, the people that work at Julius Clinical make the company unique and are the reason behind the success of Julius Clinical. They have a lot of expertise and collaborate well with each other to make our projects a success. I also like that it is a medium-sized company and that the doors are always open.
What skills have you found vital for your job?
As a CRA, you need to be able to prioritize well, because you usually have to divide your attention between multiple projects and most of the time, there is a lot of work that needs to be done. In addition, good communication skills are vital as you are the first point of contact for study sites. You also need to keep the team up to date about how things are going. Furthermore, I would say that you need good organization – and presentation skills for presenting the study protocol to sites.
Is there a typical career path for CRAs?
Traditionally, people start working in the clinical trial industry as a Clinical Trial Assistant (CTA), after which they can be promoted to Clinical Research Associate (CRA). After this, a position as Clinical Team Lead (CTL) is a common next step. Then people usually move on to a Project Manager (PM) role. However, of course, it is also possible to grow in your CTA/CRA role and become a senior CTA or CRA where you are involved with coaching the more junior team members. In addition, Julius Clinical recently introduced a new fast track program that for example makes it possible to be directly promoted from CTA or CRA to Associate Project Management. So even though there is a classical career path that you can follow, there are a lot of different options.
What would you be looking for in a new team member?
We are always looking for team members that are enthusiastic and eager to learn. This is especially important if someone is new to the clinical research industry because there are a lot of standard operating procedures (SOPs), guidelines and rules that you need to learn by heart. Patience is also a characteristic that can be very helpful for this job. But at Julius Clinical, we will always help someone out wherever we can. For example when someone is new to the industry, they don’t usually start working on a project right away; first, they will get sufficient time to get comfortable with all the information and different tasks.
We would like to thank Emma for taking the time to give us a glimpse into the role of Clinical Research Associate (CRA) at Julius Clinical. Do you want to know more? Or do you have a question for Emma? Don’t hesitate and get in contact!
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