What to expect on the job? - CRA edition



What to expect on the job? - CRA edition
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As the CRA is kind of mysterious creature, with all kind of tasks, responsibilities, always on the road, and often found in bizarre situations, I decided to shed some light on what typically the job of a CRA looks like. So, let's dive in!
As mentioned in my first article, How to become a CRA for dummies in 7 steps (or less), the Clinical Research Associate (CRA) acts as a liaison between a sponsor company (e.g., the pharmaceutical company paying for the study's execution, usually a patent holder) and the clinical research sites (i.e., the medical facilities where the investigators administer the investigational medical product to patients).
As a clinical research associate (CRA), your day-to-day activities can vary significantly. depending on the phase of the clinical trial and the project-specific tasks assigned to you.
Nonetheless, there are some general tasks that are part of every CRA's job characteristics, and I will go through each one of them.

Site Visits

A significant aspect of a CRA's job is to conduct site visits, ensuring that the study is conducted according to the protocol, ICH-GCP guidelines, and regulatory requirements. Typically, you would follow a monitoring plan that provides the timeframes for on-site visits. The frequency of this visit will also depend on the enrolment rates of your assigned sites. During these visits, the CRA reviews study records, medical records, patients' source documents, and case report forms, while verifying that the informed consent process was properly conducted. The CRA also observes study procedures, monitors adverse events/serious adverse events, performs accountability of the IMP (investigational medicinal product, aka the study drug), and reviews/updates the study on-site file (or "your folders down there," as one of my PIs refers to it) or any other site activity required to be done at the site.
Once I was called on site, because the SC had a panic attack, since in the protocol requirements for this particular visit, a faecal specimen was required to be collected form the subject and the subject was in no position to provide anything for collection. The SC kept the subject in almost a hostage-like situation with the hope that she would get what she needed. Eventually she dismissed the poor patient to go home and I have recorded a minor protocol deviation. Needless to mention, the study coordinator was a newbie.
It is important to mention that there will be sites with which you will have a great relationship with, and visits will be pleasant, enjoyable, and productive. The team will perform their job well, with extreme discipline and attention to detail, and the entire study will generally go smoothly.
However, be prepared for the fact that not all investigators are easy to communicate with. Some may be tired, busy, grumpy, or overloaded with work, and the CRA visit may be the last thing on their mind. Some PIs may be quite tough to work with, but unfortunately, not speaking with them is not an option, as you need to get your job done. I will review these types of investigators/situations in detail and explain how to handle them in another article. I’m just going to mention here that it's important to keep in mind, that first impressions are crucial. It's your responsibility to present yourself in the best possible way, as this will be the foundation of your future relationship with the site.
In terms of types of site visits that you will most likely conduct, here are some examples:

Feasibility, Site selection or Site qualification visits

Feasibility or pre-study visits are conducted to identify potential sites. The goal is to meet with the potential principal investigator and study team to confirm their readiness to take on the trial, and most importantly, to ensure that they have a sufficient patient pool for the respective study indication.
In some (larger) companies, the start-up team is conducting these visits and the study is being handed over to the CRA just prior the site initiation visit.

Site Initiation

Site Initiation Visits (SIVs) occur once the site has been selected, the study has been approved, all CTAs executed, and of course, the PI knows his Rave password (that is the ideal scenario, in most cases he would have missed the registration email).
SIVs are usually tough, demanding, and time-consuming as you will need to train your site on the protocol, vendor systems, labs, safety, study drug handling and all there is to know for proper study conduct. Needless to say, it is highly recommended to have red the study protocol prior to the visit.

Routine Monitoring Visit

Here's where monitoring really shines. These are the most common visits that a CRA will conduct throughout the study's duration. They involve a significant amount of source data verification (SDV), review of informed consent forms (ICF), and verification of eligibility. During these visits, your job is to closely monitor patient safety and any protocol deviations. If you don't have bloodshot eyes by the end of the day, you're not doing it right.

Site Close Out Visit

I had a colleague whose mantra for close-out visits was "Throw the ISF (investigator site file) on-site and run." In many cases, the process may not be that simple. Here you have reached the point where everything needs to be wrapped up: all documentation must be perfect, all action items completed, all logs have to be signed and all IPM/study equipment returned.

Motivational Visit

This visit is usually performed for slow-enrolling sites that are having trouble with recruitment. These sites may not be able to reach their preset enrolment targets, may not have enrolled a patient in the last year, or may simply lack motivation to work on the study. Ideally, you would want to identify the exact pain point that led to this visit initially.
These are, fortunately, not that frequent. You probably would get 2-3 of these per year. However, when they happen, you will suddenly become religious.
If you are interested in further details on how to prepare and what to do on each visit, subscribe to my newsletter. I plan to write a separate article dedicated to that.

Planning and Preparation

Reading emails should be your first activity in the morning while sipping on your coffee. Hopefully, there are no SAE alerts at your sites. When not visiting sites, you will spend the majority of your time replying to emails, preparing and reviewing trackers, following up on site issues and action items, reviewing protocol deviations, and working closely with the whole project team to ensure your study is going smoothly in all aspects.
All of this is required for you to be well-prepared for your next on-site visit. You usually want to have a great overview of all that has been done and what needs to be done.

Monitoring and Reporting

The CRA is responsible for ensuring the accuracy and completeness of study data. They review data listings, identify discrepancies, and work with site staff to resolve any issues. After each on-site visit, the CRA prepares a detailed report and sends it to the sponsor. This report provides an overview of the study, including any issues at the site and updates on study progress. It's crucial not to hide any issues from the sponsor, even with good intentions, because they will eventually come out. Failure to report an issue could and most probably will lead to blame being placed on you.

Administrative Tasks

These tasks could include managing study supplies and equipment, maintaining study documentation, filing paperwork, and preparing for audits or inspections.

Training and Development

As a CRA, it is crucial to stay up to date with industry regulations, guidelines, and new technology and innovations in Pharma. Attending training sessions, seminars, and conferences can be a great way to enhance your knowledge and skills, and more importantly, to broaden your network of contacts in the healthcare space. These events can also be enjoyable, as they often include networking opportunities and fancy cocktails.

Is it for you?

Overall, the CRA job is extremely exciting, dynamic, never-ending, and full of dynamics. I guarantee that you won't get bored. Just make sure to come ready and prepared to take up on a challenge πŸ˜‰ Most importantly, it is extremely fulfilling and creates a good feeling in your soul, as you are a small part of something huge, that, one day, will make someone's life better.