Introduction

When I grow up, I want to be a Clinical Research Associate!”

– no one, ever

If you’re reading this, there’s a high chance you had never heard about this role until someone mentioned it or you stumbled your way into clinical trial research and found this to be your next option for career growth. I don’t blame you for that.

Truth is, there are very few of us who end up in this industry intentionally. Most times, it’s through an acquaintance or relative who lends some guidance to your soulless drift through limited options, figuring out what you want to do with your life sciences degree.

Bonus points if your parents wanted you to be a doctor of some sort and you realized pretty early on it wasn’t for you but decided to continue Biology as a major because you didn’t really know what else you want to do. We can form a support group, just say the word.

Despite my somewhat negative start, being a clinical research associate is actually something a lot of people end up doing for 20+ years. As a choice. They love it and decide to make this their long term career. If you handle it well enough, there are many perks to this role. This is post is good, chill way to find out what a CRA is, does, and is something for you to think about. If that’s something you’re interested in, keep reading.

What does a Clinical Research Associate (CRA) do?

Clinical research associates go by CRAs or monitors for short. Their primary goal is to oversee clinical trials and make sure the principal investigator (PI) and his/her/their staff is following the protocol and safety compliance set by the clinical research organization (CRO) or sponsor (pharmaceutical company or biotech that is developing the drug being tested).

Anytime the term “clinical trials” is used, it always refers to trials in humans. These trials will have an investigational medical product (IMP) or device that is being tested for safety and efficacy in a selected group of people before it’s released into the market for the public to use, either over-the-counter or through a prescription/treatment.

Why do we Need CRAs?

Most pharmaceutical companies don’t perform their own clinical trials. They outsource them to clinical research orgs (CROs) who specialize in conducting trials. CRAs usually get employed to work at CROs and get assigned studies to monitor.

For example, the CRO you are working in has a cardiovascular study regarding hypertension that is ready to screen and enroll subjects. A CRA may get assigned to this study, and under this study they will be given multiple study sites to handle that have been selected to be a part of this trial. The CRAs are the primary source of contact for these study sites regarding any questions or concerns with the protocol and/or drug. They must have thorough knowledge of the protocol. They are the face of both the sponsor and the CRO.

The role of a CRA is highly specialized and limited to certain phases in the whole drug development and approval process. They get very good at what they do since they cover a very desirable but ultimately niche spot in this industry.

It sounds daunting to have to know a full protocol but it’s actually not that bad, especially if you’ve been reading research papers as part of your academics in college. The protocol is written in language that is not exactly layman but also not super technical. CRAs are usually given 2-3 protocols max since companies know it’s impossible to expect in-depth knowledge of more. Even 3 is a stretch. It is therefore important to be detail-oriented in this role.

CRAs also look at source notes (subject data taken during visits) ensure it matches what the staff put in the Electronic Data Capture system. The consenting process is also reviewed to see if everything was done ethically, the subject was given time to go through the Informed Consent Form (ICF) and their questions were answered. You make sure any assessments, physical exams, labs, any study procedures at all, were done on time and deal with any protocol deviations if not.

Essentially, monitors are called monitors because that’s literally the job. You’re monitoring all study activities at the site on a set visiting frequency and dealing with both the good and the bad that comes with it.

Traveling for the Job

This role is and mostly always will be travel-based. Depending on the CRO or sponsor/biotech you’re working in, it can range from 40-80%. The way the travel metrics are measures or required can also change based on the company and studies. You will need to travel to visit your sites for on-site monitoring.

On the upside, you get to visit many different places, meet new people you make connections with and get to develop a lot of new facets in your personality that are hard to come by when staying in one place.

Before you get super excited about the travel, though it IS exciting, you should know that traveling for fun and traveling for work are two very different experiences. When you’re traveling as a CRA, depending on your travel metrics, it gets so busy that you end up being at site during the working hours and then coming back to your hotel to unwind for a bit before catching up on emails and writing reports. There isn’t a lot of time to hang out or explore. I’ll delve into the day to day of a CRA in a later post but I do want people to understand that traveling for work is somewhat glamorized.

Okay not somewhat, it’s really glamorized.

However, like I said, there are people who love this line of work and do it for 10-20 years!

Happily

All of this to say, everyone is different. Travel fatigue and time zone differences along with the fast pace can be a great rush for some but very exhausting for others. You can also fall somewhere in the middle, like I do. It’s hard to know how it will be for you until you experience it yourself.

Personal Experience

Many people have mixed feelings about being a CRA and I can’t really say otherwise. I think in isolation from all the bureaucracy and always-urgent timelines, it’s actually a very cool job. When you take a step back, there are few roles that give you this much exposure, agency, and movement. I would say overall, my experience has been and continues to be positive. However, it’s not without its pitfalls and hardships.

I remember when I first became a CRA, one of the older CRAs who was giving me some tips told me that being a monitor is like being an independent business. You do your own expenses, you book your travel, you arrange your schedule, you go out to sites and you do your own reports. If you aren’t making a whole mess of it, you meet your manager once a month to say all good and continue on. In most roles you’re in charge of your metrics, but in this one I feel like since you’re home when you’re not traveling (it’s almost always a remote position or the burnout would be insane) you never meet anyone and mostly work on your own. This can be great for some and isolating for others. There is also a sense of pride that comes from doing everything so independently and managing sites while juggling life at home.

That’s not to say you never meet anyone from your company…but those instances are few and far in between.

Something to keep in mind are also travel perks like the points you collect in airlines or hotels. It makes it so your vacations are almost free when you go out with family which can be convenient.

Conclusion

CRAs or monitors work on behalf of the sponsor usually via a CRO to ensure patient safety and protocol compliance. They work with their sites to ensure the proper steps are being followed, the inclusion/exclusion criteria is in place and those enrolled are not randomized in error. CRAs have make sure the consenting process was done according to the conventions needed to be followed and no coercion took place. They must also review and confirm if the data points entered in the system match the source notes taken during the subject visits. They relay all important communications between the sponsor and sites and are the main point of contact for the sites. CRAs represent both the sponsor and the CRO when they go onsite and traveling is a big portion of the job.