How to become a CRA for dummies in 7 steps (or less)

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Nowadays, many people have become interested in pursuing a career in clinical trials. This may be due to the Covid-19 pandemic and the boom of vaccines, which have actually been around for a while (remember smallpox? It did not vanish into thin air by itself). Alternatively, it may be because the pharmaceutical industry is a lucrative field where people can earn good salaries and benefit from intellectual property rights.

As a result, I am frequently asked by people around the world about how I became a Clinical Research Associate (CRA), how I started my career in clinical research, and how to get noticed by a Contract Research Organization (CRO) or pharmaceutical company. In this article, I will share my experience and insights with the hope that many of you will find it useful and learn from my mistakes.

Formal Education

Let's begin with the first step: obtaining the right education for the job. This typically involves a degree in medicine, pharmacy, or a related field with a strong scientific background. While it is not impossible to enter the industry with a degree in finance or psychology, it will certainly be more challenging. The majority of people working in the industry have a medical degree - this includes your colleagues, hiring managers (especially in larger or better companies), and the primary investigators (PIs) at the clinical sites. Therefore, having a medical degree will give you a better reputation and make a better first impression. Not to mention that being a CRA requires some degree of medical and pharmaceutical knowledge. You'll need to participate in medical discussions with investigators, monitor a lot of safety data (including adverse events and patients' treatment), and have a basic understanding of each therapeutic area you're working in.

Experience

Experience is the harder part. At the beginning of my career, I faced a lot of rejection. I was already in my final year of medical university, but I had no experience as a clinical research associate. Every single CRA position I applied for required some experience. However, there is a workaround. You could still land your first CRA interview and job offer by working on different, less "fancy" positions still within clinical research, such as study coordinator at a clinical site, project assistant at a CRO, junior CRA/internships, or in my case, clinical application specialist for a couple of years. The idea is to gain as much experience as possible, be extremely proactive, and be willing to invest in your career long-term. At the beginning, your salary might not be high, and your job might not be that interesting, but you need to invest in this to gain enough knowledge and experience to land a CRA position. Even if you have to suck it up for six months to a year, it is worth the investment.

Another tip is to start in a smaller, less pretentious CRO, which, like yourself, has moderate experience in clinical trials. Usually, the clinical research industry is old, and companies discovered 5-10 years ago are considered startups. These companies are most likely to hire newbies, first because they would struggle to afford an experienced CRA salary, and second because they prefer to invest in the people they hire long-term thus it makes sense for them to hire rookies. Therefore, you could start your career with a smaller CRO, still learn a lot, and later on, if you decide to explore more options, you will already have CRA experience on your CV, which will make you a desirable candidate (in combination with your medical degree).

Non-formal education and additional certification

There is a significant amount of information available online regarding the position, how to prepare for the interview, and how to handle CRA responsibilities on the job. Compared to when I was starting out, there are now many more options available. What I would personally recommend is to search for all sorts of job descriptions and characteristics (usually found in every job posting) and then research each one of them. Another thing I have done is to follow and watch every single video on YouTube about CRA's daily life. This will provide estimations on what to expect, your responsibilities as a CRA, and what is expected of you.

Additionally, there are plenty of available post-graduate programs and certifications for future CRAs, including courses and online academies. Here are a few examples:

The most important requirement is to obtain GCP certification. Good Clinical Practice certification is required for all clinical research professionals working at the clinical site or as a monitor (CRA) for the study. Without it, you cannot be a monitor. Additionally, you need to re-certify yourself every two to three years, depending on your company requirements.

Dan Sfera, also known as The Clinical Trials Guru, was the first person I started following a long time ago. At the time, he was the only one who spoke about clinical trials and offered additional information about the space. You can find more information about him here.

Viares: They offer various online certification programs for clinical research professionals, from study coordinators to CRAs. You can find more information at their website.

CRA Connect: I recently connected with Maria on LinkedIn and was delighted by her passion and dedication for clinical research. It was refreshing to meet someone with similar interests and ideas like me. She launched her CRA Academy, CRAConnect, on March 8th. The academy is not just a platform for online CRA courses but also a vibrant community of over 10,000 followers seeking accessible and engaging education. If you're interested in becoming a CRA, I highly recommend checking out CRAConnect. Here is their website.

Harvard School of Medicine: They offer the Global Clinical Scholars Research Training program, a research program for clinical professionals. You can find more information at their website.

However, I have never paid for such a course (partly because I was broke in my early 20s), and I believe you could still achieve the same result by doing good research yourself.

Keep in mind that, apart from industry knowledge, as a CRA, you'll need a variety of skill sets to do your daily job, including administrative skills (accurate documentation), IT and computer skills (databases and systems management and those are crucial), written and oral communication skills, keen attention to detail and organization, ability to manage and coordinate with several stakeholders, strong understanding of clinical research trials and healthcare space, and medical terminology. Problem-solving skills are also crucially important, as the majority of the time, you will be the first point of contact for all clinical sites. Lastly, you'll need a driver's license, as you'll be traveling a significant amount of time.

Proactivity is also needed - make sure you have access to all sorts of CRA groups on social media, podcasts, YouTube channels, etc. This will give you plenty of insights on the industry and what's been going on so that when you go to a CRA job interview, at least you'll sound like you know what you're talking about.

Building your own network

Networking - as I mentioned earlier, in order to become an effective CRA, you need to be aware of innovations in your field, and building a network of contacts is crucial. LinkedIn is a great platform for this; you can follow all global pharmaceutical companies and CROs, join relevant CRA groups, and learn a lot about various topics in the healthcare space. You should also build your personal network by connecting with industry professionals who have already built successful careers, people with numerous contacts in their network, and other CRAs from around the world. These connections can be useful when you need them, or at least they could help you get you noticed in the industry. In fact, all Pharma recruiters are on LinkedIn, using it to hunt for new talent and search for suitable profiles for their job postings. So it's important to be active on the platform - comment, like, share, post, and write articles to increase your visibility. The more persistent your involvement, the easier it is to find and connect with new people as this is how the algorithms work.

Attending various types of pharmaceutical events such as conferences, seminars, and summits can also be greatly beneficial (although a bit pricey if you are paying for yourself and not going as a company representative), as they provide the opportunity to meet industry professionals face-to-face, whom you may not have been able to reach otherwise. If you manage selling yourself effectively, you might even leave with an interview invitation or at least a valuable contact.

Expectations

Here I would also like to discuss what you should expect now that you have landed your first CRA job. It is important to understand that everything you have learned so far, including online resources, courses, and podcasts, is just the incredibly small tip of the iceberg. I don't mean to discourage you, but it's important to realize that the CRA job is extremely vast and no course can fully prepare you for it. You will be required to make daily decisions and be responsible for several clinical trials, including their execution and all clinical sites and staff involved in the studies. The ability to think critically is also of great importance, as you will often be the only one familiar with the situation you are dealing with at the moment.

A Clinical Research Associate job requires a lot of traveling across the country, visiting different hospitals and performing various types of visits including selection, initiation, monitoring, closeout, and audit. In general, most companies require approximately 8 days spent on-site visits, considering that the sites could be located anywhere in the country. This may not seem like a lot; however, if you are looking to do that long-term, you should also consider whether you will be comfortable not being at home for at least 2 days per week, with some overnight stays in different hotels. While the dynamic environment can be extremely fun and exciting, especially in your early 20s, you need to also consider whether you would like to have the same lifestyle once you are settled and have started a family.

Apart from that, you can expect to be heavily involved in monitoring patient files, medical records, and all collected patients’ data during the study. You will communicate on a daily basis with project managers, and in some cases, with sponsors (the pharmaceutical company paying for the study being executed), as well as doctors and study coordinators from the sites. Your job will be to ensure that everything concerning the trial is done according to the protocol requirement and FDA or EMA regulations, and, of course, that the PI knows how to reset his password (yes, this falls under your responsibilities as well).

There are definitely some undeniable perks of being a CRA. You get a highly competitive salary, which can range from 70k to 120k annually depending on your level of degree, experience, the company you are working with, and the amount of visits per month. Additionally, many companies offer yearly and performance-based bonuses, car and meal allowances, and 25 days of paid leave. Most monitors work remotely, which is becoming more of an industry standard. The majority of companies offer similar packages with minor differences. Some larger CROs also offer a sign-in bonus.

The job of a monitor is extremely interesting, challenging, and dynamic. However, it's up to you to decide whether you can handle the stress and if you're ready to take on this challenge. It's definitely not for everyone.

As the topic of what to expect once you become a CRA is very broad, I will provide an in-depth review of the daily tasks and responsibilities of a CRA in a separate article. I will also cover how to handle certain situations and share my personal experiences. If you are interested, you can subscribe to my newsletter.

Career growth and opportunities

Career growth and long-term opportunities are important to consider when pursuing a job as a Clinical Research Associate (CRA). Once you have landed your dream job as a CRA, it is essential to think about what comes next. When a CRA reaches the senior level, there are typically three main routes a career in clinical research can take: trial process management, people management, or project management.

It is important to note that titles and positions may vary significantly depending on whether you are working for a Contract Research Organisation (CRO) company (such as IQVIA, PPD, or PSI) or a Sponsor company (such as Pfizer, AstraZeneca, or Novartis).

The career paths for a CRA are as follows:

Clinical Team Management:

A Clinical Team Manager is responsible for acting as the direct line manager to associates. Clinical Team Managers will manage and support team members, ensure staff are trained effectively, review the effectiveness of business processes, and plan professional development activities.

Clinical Project Management:

A Clinical Project Manager is involved in the planning and directing of clinical trials and is also responsible for evaluating clinical data. Day-to-day tasks include maintaining study records, ensuring activities are being delivered on time and on budget, interpreting study data, and developing trial plans.

As there are many career progression paths for a Clinical Research Associate (CRA), I will provide further insights and an in-depth review of what comes next, as well as different career paths that you could pursue in a different article. If you would like to receive notifications for future articles, you can subscribe to my newsletter.