Embracing failures on the journey
Do not index
Do not index
Ahh, FAILURE - I would be lying if I said that writing this article does not bring a solid amount of anxiety to my heart. However, recently I have realized that along with all our successes, our failures are equally - if not more - important on our way to greatness.
When I think about it, all the major life lessons I learned were from my failures. Not that one cannot learn from positive experiences as well, but you know what they say - smart people learn from other people's mistakes, the stubborn ones learn from their own, and the stupid never learn.
When I had the idea for this article, I have to admit it mortified me. No one wants to have their mistakes and embarrassments published out there for everyone to see.
Each time I go on social media, I realize that everything on there is "fake" as all of us want to present ourselves in the best possible light for society to see. Our LinkedIn or Facebook profiles are not us - as much as we would like to identify with them. These are only the "polished" versions. But even knowing this, I still catch myself sometimes comparing myself to others whom I presume are "more successful than me" in some aspect. In those moments, I always try to remind myself that this is precisely what social media is designed for, but more importantly, I cannot see the bigger picture for this person - I do not know their struggles, their background, nor what they have been through to get where they are today. I do not know if they are happy or miserable, or whether this is the life they have chosen for themselves or if they are truly following the desire of their hearts. The truth is, you cannot compare where you do not compete.
“Seventy percent of young people experience Impostor Syndrome. Those who experience it are high achievers unable to internalize and accept their success. They often attribute their accomplishments to luck rather than ability, and fear that others will eventually unmask them as frauds. Millennials are particularly susceptible to Impostor Syndrome due to technological advancements within their lifetime, societal pressures, and social media comparisons.”
*you can read the full article here.
Studies also show that Imposter Syndrome affects more women than men, with around 40 % of young female professionals saying they feel intimidated by senior people, compared to just 22 % of males. The anxiety of being "exposed as a fraud" is extremely common among graduates, and the lack of experience is often the main culprit, especially for those moving into roles within highly competitive industries (such as clinical research). However, in order to gain experience, one must first get hired in the industry, which is not an easy task in itself. It is a "Catch-22".
Imposter Syndrome in clinical research is also a topic that deserves further exploration, but that's for another article (subscribe to my newsletter✌️).
Imagine you messed up big time. Now imagine the whole world knowing about it. Sucks, huh? But now - imagine reflecting on the situation and trying to see it from a different perspective - what went wrong? How could you have done better? And what could you do to avoid it next time?
In that train of thought, I decided to share some of (far from all) my failures through the years, both personal and professional, which helped me far more than I realized at the time to become a better expert in my field and a better human being in general.

My First Job as a CRA

Let me take you back to 2019. As my lifelong dream was to become a Clinical Research Associate (CRA), I lost count of the number of CRA job posts I applied to, but it was likely around 200. At the time, I was working full time as a clinical research expert with C3i (now HCL) while still at university. Although it was still related to the field, I was in a support role, dealing with the back end of the processes happening in the Clinical Trial Management Systems (CTMS) and communicating with sites, CRAs, and project managers. However, I did not want to pursue assistant roles which were generally easier to get hired on. I wanted to become a real CRA, so in my context, I was aiming for the stars. Despite my enthusiasm and passion for clinical trials, due to being in university and lacking previous CRA experience, no one wanted to hire me. I was prepared to face a lot of rejection, and I certainly did. Almost everyone that I've told about my desire to become a CRA, they just laughed and jokingly wished me good luck with it.
One day while walking my dogs, I received a call from a very nice lady inviting me to a CRA interview. It would be an understatement to say that I was ecstatic.
During the interview, my employer-to-be, asked me about my high school, as he happened to be a benefactor for the National High School of Science and Math, which I attended. I think I impressed him with that 😃. I also remember him asking whether I liked to drive. At the time, I had my driving license but had only driven occasionally as I did not have my own car. Nonetheless, I loved to drive, so I said yes. He hired me, and the following week I had my first monitoring visit. Needless to say, I had no idea what I was doing, but I tried to implement everything I had read the night before about routine monitoring visits, so I would at least look like a CRA.
At the end of the visit, I accidentally crashed his car on the hospital parking lot 🤦🏼‍♀️. I was sweating the entire way back to Sofia, trying to figure out how to explain what had happened. At one point, I thought he would fire me on the spot. He did not. That is another beauty of mistakes - usually, people are a lot more forgiving than you might think, provided that you have the courage to stand up and take accountability.
At least I knew how to write a monitoring report since I had managed the CTMS for plenty of studies in my previous role. However, I thought that ISF or TMF were plugs on my laptop (I know it is hard to believe after this comment, but I also worked as an internet engineer for Sky b.c. - before CRA). And don’t even get me started on MS Word. Back then, when reviewing a document, I thought “accept changes” meant sending back an email with the text “Dear….., I accept the changes in the document.” We had a few back-and-forths on this.
Of course, with time, I have learned a lot and become a much better monitor (duh, after all, when I started, I knew less than Jon Snow), my driving skills have also improved, as well as parallel parking. I believe it is safe to say that to this day, I keep learning new things about clinical trials, and I am constantly trying to improve my skills and knowledge. There is always room for improvement and this is one of my main drivers.

Communication with my sites

Throughout my career, I have experimented with different approaches in communicating with my sites. I have tried being extremely professional and keeping communication with the team strictly official. I have also tried being more friendly, hoping to build better trust with my sites. However, I have found that there is no perfect recipe for building a good relationship with your sites. It is more about adapting to the site team's communication patterns and letting them take the lead.
As an extremely extroverted and chatty person, it has always been challenging for me to maintain a strictly professional relationship with my investigators. It comes naturally to me to ask about their kids, invite them to lunch, or ask how their holidays were. However, I recognize that for many people, especially doctors, this would cross professional boundaries and would not be appropriate.
Over the years, I have had several instances where my friendliness has bit me on the butt. Recently, I had a co-monitoring visit at one of my sites with my study lead. This particular site had never had prior clinical research experience, and I saw it as a challenge to work with a complete "newbie" site to test my skills of teaching proper study execution. I taught them everything they now know about clinical research, from GCP to how to write patient source files. As a result, they are now one of my top-performing sites, and we have built good relationships with the PI and SI, to the point I now consider them part of my friend circle.
During the co-monitoring visit with my study lead, I had high expectations that he would leave the site with the impression of having seen the best-managed site in his life (I know, it sounds a little bit cocky), and that he would have no comments about the documentation. However, very predictably I must say, this was not how it went, and he did have several comments about things that I really wish I had seen beforehand. These were not major issues, but rather small details that I had overlooked. This caught me off-guard, as I was super confident in my abilities as an experienced CRA. To make matters worse, he also asked the PI and SI to leave the room while we were examining their files (at this point it was really more him reviewing my work), which only added to my anxiety. Later on, I realized that he did ask them to leave because he did not want to undermine my authority in front of the site team by discussing my mistakes in their presence. However, at the time, this seemed rude to me, as it was not my customary way of communicating with them.
All site issues are eventually fixable; however, this situation has damaged my relationship with the investigators. They no longer trust my judgment as they used to before and now request a second opinion from my lead all the time. They feel offended by the way we treated them during the visit. Needless to say, we are no longer on "friendly" terms. Despite this, our bottom line is to work together to get the job done, nothing more and nothing less. This was a lesson for me to learn: to keep a little bit of distance. At the end of the day, it is just work.

Dealing with superiors i.e., “difficult” managers

Phew, this is a tough one. I have to admit that throughout my modest career, I have almost never faced a challenge with "difficult" managers. It's quite the opposite-almost all of my managers have been amazing professionals and mentors whom I look up to.
However, the situation with a difficult manager is painfully familiar to many people, and it is usually the original cause of CRA burnout, switching companies, and in some cases, even careers. Remember, people never really leave certain positions but rather toxic work environments. For the most part, it is up to the managers to create a positive work environment.
I have been in situations where, at some point, I felt extremely frustrated, overburdened, and mostly unheard by my manager. I'd like to add to this part that communication with other people is often the most challenging part of the job, regardless of the field. This could happen in both online or face-to-face communication (there are things that could be left unintelligible in both types) and could leave the other person with a bitter feeling after the conversation, simply because you did not express yourself properly, or the other party understood something completely different. In many cases, you could just be lost in translation. Or in rare occasions, the manager could simply be an arse 🤷‍♀️.
Personally, I have a straightforward approach to things. If I dislike something, I bring it up, discuss it, come up with an action plan, and try to resolve it. However, this approach may be outside the comfort zone for many people, who may instead engage in what is called "quiet quitting."
*To learn more about "quiet quitting," click here.
There is no playbook for dealing with situations like this, but from my experience, I can give you a few hints:
  • Don't take it personally. It's rarely personal. Usually, it has something to do with work overload or the other person's character, rather than you.
  • If you decide to address the elephant in the room, speak directly with the manager in question. This will save a lot of wasted time and energy and will leave no room for interpretation from your colleagues. You don't want to get into the game of he said, she said.
  • Express your frustration towards the situation, NOT towards the person. This is a hard one, I admit, but what I try to do is very carefully pick my words (it helps if you come prepared for the meeting - write down everything you wish to address) and figure out a way to talk about the particular situation/issue, rather than focusing on how this made you feel. If you fail to do so, things can get personal very easily, and it's a rabbit hole from there, trust me. Also, try to have such conversations on Friday, as this will give all parties time to calm down, think things through over the weekend, and start the next week with a fresh perspective 😉.

Audit: my first major finding

Rather soon after becoming a CRA, I received an email that can induce fear even in the most fearless CRAs out there.It was notification that I was about to undergo my first audit. The study had already completed the enrollment period long before I became a CRA. Additionally, there were no active patients at the site, and I had never met the site team. Nonetheless, the audit was only a week away.
The next day, I called the site to arrange my first routine visit, only to discover that the principal investigator (PI) did not speak English and had only a vague recollection of the protocol specifics. Additionally, the on-site files were almost non-existent, and we lacked patient source files (or at least we lacked them in a format, in which they could be presented to the auditor) for approximately two-thirds of the patients.
Now, the normal reaction to this would be any of the following: inform my superiors, try and re-schedule the audit; ASK FOR HELP; any of the above would do. What did I do? In the spirit of being a young and ambitious CRA, I have decided “challenge accepted!” and dove headfirst into the pit of my downfall.
notion image
I spent the entire following week on site, working from dawn until dusk. During this time, I taught the PI the protocol, good clinical practice, basic English skills, and more. In addition, I assisted the SI in preparing proper source files for most of the subjects. During my spare time (on the weekend), I worked on the OSF. I must note, however, that at that time, the OSF was still a bit of a mystery to me, therefore, I hardly did the best job possible. At certain points, I only left the site to walk my dog at around 9 PM so that I could come back and wrap up for a couple more hours.
Monday arrived, and with it came the Swiss auditor. I arrived at the site at 7:20 AM and looked through the window to see the auditor already in the PI's office having coffee and chatting. My heart sank; this could not be good.
I entered the room, introduced myself, and attempted to engage in positive small talk to build rapport with the auditor. However, my tendency toward over-friendliness (yet again) and talking too much did not work this time, as the guy was Swiss. To my surprise, apparently the English lessons I have been giving the PI paid off. He found himself blurting out far more details than necessary, which would have been better left unsaid (unless specifically asked for).
At this point, you're probably already guessing, but the audit went dreadfully. Two days of misery ended with my first major finding. There were also some minor findings, but I remember feeling relieved at the end of the audit, because I thought it could have been much worse 🫥.
On top of that, I had to explain to my manager why we were in the situation we were in, and NOW I had to ask for help to fix all the CAPA actions. It took me six months of hard work with the site and a significant amount of damaged ego to fix what I had messed up. I wish I could say that I learned from this situation to ask for help when I need it instead of thinking I can do everything on my own, but it took me several more failures to realize what it means to be part of a team and that help will always be given to those who ask (I stole the last line from Prof. Dumbledore 🧙‍♂️).

The silver lining

I wrote this article with brutal (95%) honesty - as Tars says in Interstellar: "Absolute honesty isn't always the most diplomatic nor the safest form of communication with emotional beings." I figured the same applies to the pharma industry.
I am sharing all of this with the sole desire to keep things real, especially in a world where we are constantly surrounded by the illusion of "perfection." I firmly believe that growth happens precisely from our biggest mistakes, as long as we are able to learn from them and strive to do better next time. For me, sharing my most uncomfortable experiences also helps me gain clarity on where things went wrong and how I can improve for future reference. Of course, that doesn't mean I won't make mistakes in the future, but I like to think they will be a different set of mistakes. And honestly, I can't wait! I hope you have also learned something from mine ✌️.