In this series, we will be speaking with Simbec-Orion staff and asking them about their day-to-day work, what it involves and how they see their role developing in the future. In our first post, we are meeting Dr Maria Kozlak, a Clinical Research Associate (CRA) at Simbec-Orion. We’ll take a look at a day in the life of a CRA, considering what a clinical researcher does and what Maria enjoys about her role.
Introduction: Dr Maria Kozlak
After completing her PhD in pre-clinical studies on novel anti-cancer treatment at the Curie Institute, France, Maria Kozlak was interested in moving her career toward clinical research.
She joined Simbec-Orion as a Clinical Trial Assistant – a position that allowed her to have a broad overview on every department in clinical research, as her duties were focused mainly on supporting the management of clinical trials. In that role she gained exposure to many aspects of trial management and advanced her career as a Clinical Research Associate (CRA). She is based in Belgium.
What does a Clinical Research Associate do?
The CRA supervises the clinical trial on behalf of the sponsor, and that supervision takes place daily, not just during the on-site Monitoring Visit (MV). The main tasks of a CRA are to ensure patient safety and to guarantee the quality of the trial data.
To carry out these functions, CRAs visit the hospitals and verify that everything is being carried out in accordance with current legislation and following the established Protocol. To ensure quality of MV a solid preparation for that visit is necessary and as well after adequate follow-up.
A non-monitoring day for a CRA is therefore either preparation for the next MV or following-up on actions from completed visits. This can include preparation of MV reports and related correspondence, developing trial materials and distributing to study sites, providing Clinicians and Study Coordinators with guidelines on how to perform the specific aspect of trials, overseeing progress throughout the duration of the clinical trial and communicating it with sites.
And what would you do on a monitoring day?
Monitoring Visits are very complex in terms of tasks and responsibilities; therefore, it is important to set priorities. The most important consideration is patient safety, and it is that which drives all the monitor’s work.
It is a CRA’s responsibility to make sure that investigational site personnel are performing the study as per Good Clinical Practice guidelines. The CRA also ensures that the investigational site complies with all appropriate regulatory specifications and performs source data verification.
We also evaluate the reliability of drug accountability records and carry out other administrative responsibilities. The CRA is responsible for training the site personnel, and such training needs to be adapted to the needs of each site. Very often training can be done remotely, although my preference is to do it on site.
Importantly, the monitor needs to document everything, as document control in clinical trials is not optional.
What are the biggest challenges of your role?
In my opinion, communication with the site. Belgium has three official languages, but it doesn’t mean that every site personnel speaks all of them and is fluent in English. It is important to take this into consideration in all communication with the site.
Also, very often the sites have their own standard operating procedures that we need to adapt. Some Site Coordinators have their own way of working, and we need to find the best way for efficient collaboration during the study conduct.
How has your role changed as a result of the pandemic?
I moved into the role during the pandemic, so although I have an idea about the role of a CRA in pre-pandemic times, the fact is that I only fully experienced the CRA role during the pandemic.
During the pandemic, we saw changes on the recruitment level and use of technology. Clinical Research fundamentally changed. Even today, post-COVID, it is not always possible to perform on-site MVs, so for every project we now have a remote site monitoring and management plan in place.
During the pandemic, there was always the question of how the site had changed to account for the limitations of the pandemic and would in-person visits be possible. At most sites, some aspects, such as review of patient data, are impossible to perform remotely, but depending on the country, or even the individual hospital, there can be limitations around on-site visits such as the number of people who can visit at once.
I once had a MV cancelled on the day, due to the new government regulation relating to the pandemic. Therefore, a monitor needs to be able to adapt quickly and, in that case, set up a remote visit and perform the activities that can be done per site’s internal policy.
Frequency of monitoring visits depend on the trial and the stage of the trial, how many patients are active on the trial etc. My preference is always to go on site if that is possible. It facilitates communication with site personnel as discussion face to face with Principal Investigator and Study Coordinators are way more fruitful and easier in my opinion.
What qualities are important for a Clinical Research Associate?
From my perspective, it is important to have a strong scientific background as monitors need to have a full understanding of clinical trial documentation. It’s necessary for good communication with the trial staff who are experts in the specific investigational field. Also, knowledge of ICH-GCP and regulatory authorities’ guidelines for the country where the studies are being conducted are crucial for a CRA role.
What makes a good CRA is the ability to multitask and be comfortable working both individually but also as part of a team. Being flexible and adaptable.
What’s your opinion on decentralised trials?
There is a lot of discussion about decentralised trials and patient centricity. What do you think of these possible changes? Will they be beneficial, or will there be more challenges?
I am very interested in these aspects, and I think many clinical trials will move in that direction. The core of the clinical trial is the participant, without them you cannot run a trial. We (Clinical Trial Specialists) need to adapt to take the trials to them.
Traditionally, there are many roadblocks to trial participation such as the inconvenience of the site location, the need to take time off for trial site visits or financial constraints. I have already experienced this even in the short time I have been a CRA. These are the types of things that can prevent a participant from attending a visit and results in a non-compliance. We need to make it easier for them.
Of course, decentralised trials are not suitable for every trial protocol or every patient group, but where it is possible the effort should be made to implement it.
You very clearly enjoy your role, what do you particularly enjoy?
I really enjoy working with all Clinical Trial Specialists at sites and at Simbec-Orion. My job is not limited to CRA responsibilities, but I am growing in other aspects of clinical trials. For example, I am involved in the “Patients Recruitment and Retention Group” and “Vault Clinical Champions” group at Simbec-Orion. There are (still) things we can improve in Clinical Research that are challenging, and that motivates me.
Want to read more? View our next meet the team blog with Tracy Thomas.