TRANSKRİPT 🔗
Theodora Savlovschi-Wicks: Hi, Maria. Thank you so much for taking the time to join me today of our newest episodes of the Vivexa, the Human Protocol podcast. So I thought we'd just start with a brief introduction if you want to tell everyone a little bit about you, please.
Maria Milas: Of course, and thank you for having me. It's really a pleasure to have this conversation and be involved in this project. Of course, I am who moved to Spain ⁓ when I around 13 years old. Then I grew up and I got into the clinical research industry here in Spain, where, especially in Barcelona, we have a huge hub ⁓ in clinical research with amazing companies, both CROs and pharma, and it's just growing and growing every year. And then after that, my background is actually not in clinical research or science at all, which is in linguistics. And many, would say that was a challenge to switch into the industry. And I can definitely tell you of many. times that I heard, you cannot be a CRA coming from linguistics. The typical, this is going to be a blocker. But guess what? It's not a blocker. And then after starting in the industry as a CTA, as a clinical trial assistant, then I moved on to be a CRA. And then I was a CRA for around over five years and after getting to know the industry and understanding the role. Then I switched to the technology side, to the vendor side. And I had roles such as subject matter expert and then solutions consultant within the sales team, then marketing. And then after that, I decided it was time to embark on a new journey, as you would say. So I opened CRAConnect ⁓ that's what I'm doing now. Back in Spain, because I moved away for four years to Germany, but that German weather just could not win me over. So I came back to the Mediterranean.
Theodora Savlovschi-Wicks: You should come try London for a while.
Maria Milas: ⁓ I used to work for a company that was based in Limerick. I, know, it's similar weather to London, obviously it's different country, but still it made me understand what it would mean to live in a ⁓ of a colder, wet, more Northern country I think I was, Berlin was my maximum. That's all I can ⁓
Theodora Savlovschi-Wicks: So what you're saying is that me and my non-scientific degree still have an opportunity to become a CRA, that's what I heard. ⁓
Maria Milas: my God, If you want to, just let me know. I can give you the five steps how to become a CRA without the scientific background.
Theodora Savlovschi-Wicks: Great. So obviously, having come into the industry from a linguistic background, did you have imposter syndrome? Did people tell you you can't? Obviously, people did tell you, you can't quite do it. So what made you go ahead with it? What was it that made you think, I know, I want to do this?
Maria Milas: You know, I think most of us, CRAs or those who ended up being CRAs, we wanted to have a job or a role that would contribute and would have a bigger impact, whether through science somehow, and maybe you have a frustration of not having become a healthcare professional, or if it's not a frustration, you made a conscious decision not to do that for whatever the reason, and that was also one of my case. I made a conscious decision not to become a healthcare professional, but at the same time, you have still that curiosity, you have that passion, you have that, I remember when I was still in university and I was still looking at how can I specialize myself into that aspect of research. It wasn't specific clinical research, how can I, maybe I can do, medical translation or maybe I can do pharmaceutical interpretation at one of these big ONGs or big corporations. So I started having a touch base with that and that curiosity just never left. I was continuously reading literature, reading the news on are there new drugs, new treatments that are on the market. And it had nothing to do with the job that I was required to do. So of course, when I made that switch,
Theodora Savlovschi-Wicks: Yeah.
Maria Milas: Because I started as a CTA, at the beginning there was no imposter syndrome, I would say, because as a CTA, the industry is more open to diverse backgrounds because you're mostly giving support or you're in charge of documentation or quality or more on the administrative side. But when you switch to CRA, that's when you can get those, but what's your background? You don't have a scientific background or related. So I did hear that and I remember even, I wouldn't say it was an excuse, but I remember ⁓ of the CROs that I was working for at the beginning said, Maria, we want you to be a CRO and we have this study that you would be so great and it would fit exactly your ⁓ also or your interests. But the sponsor asks ⁓ for CROs to have some specific science related or clinical research related degree. So I give me, give me nine months. I'm going to go do a master degree. So, so that's how I sort of compensated that. But I think it wasn't, I consider myself a little bit of an overachiever, unfortunately. So I do think it was an overkill. I did not need that because the experience I was getting, I was definitely more than able and capable to do the job of the CRA, but because I did not want to hear or to have that apparent obstacle of not having a scientifically related degree or specialization. I did the first master that was in clinical research, but I do have to also say and emphasize from what I see managing and supporting thousands of CRAs in the community now. you don't need a master degree or a scientific degree that is related to healthcare or to If you have it, It's sort of a bonus. It makes it easier for you, but it's not a, if you don't have a science related degree, you can't become a CRA.
Theodora Savlovschi-Wicks: Do you think this is one of the big blockers in the industry for CRAs, the scientific degree? Obviously the industry right now is fairly volatile when it comes to job opportunities. Do you think people without a scientific degree, with all
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the want in the world, are still a bit at a disadvantage being sat next to the ones who do have a scientific background?
Maria Milas: For sure they are, but still it's not a blocker that you can't get that job. I do think that it might take longer time to find the sponsor or the CEO who might give you the opportunity, or you might have to take the longer path and then you have to start with a more supporting role, maybe CTA, study startup, regulatory, project coordinator, study coordinator, any of these that are more.
Theodora Savlovschi-Wicks: Mm-hmm. Mm-hmm. Okay.
Maria Milas: I don't want to call them level one because these are also roles that you can build a career in and then you can stay as an individual contributor for long, but you acquire that experience that can compensate any of the excuses or that you might hear from zeroes a sponsor and ⁓ you don't have that experience. So it might be in disadvantage in terms of it might take you longer, but I do think that
Theodora Savlovschi-Wicks: Mm-hmm. Mm-hmm. Mm-hmm. Mm-hmm.
Maria Milas: you can absolutely overcome that but it definitely it takes more effort so you are in disadvantage a little bit of course.
Theodora Savlovschi-Wicks: Mm-hmm. That's great. Thank you. I appreciate that view. I think we're in agreement there. Now, in terms of the CRA role in itself, it's obviously, I you and I have often spoken about, the fact that CRAs are pretty much invisible to people outside of sites and sponsors. How would you describe a CRA position to somebody outside of the industry or somebody who's never heard of a CRA title? Although obviously, if you're in the industry, definitely have.
Maria Milas: I'm Okay. Mmm. Mmm. You know, it's a great question and my parents have asked me around 50 times a CRA is and I think even today after it's been a decade since I was a CRA and not decade since I stopped, but when I started and for a decade, they still keep asking me, can you tell us again? What exactly it? What exactly does this role do? Something ⁓ in the right? ⁓ So it's a role that
Theodora Savlovschi-Wicks: You Mm-hmm.
Maria Milas: If you don't have any touch base with this industry, you might not have any insight into what this role is at all. Maybe you haven't even heard about it. So I would say in plain words, CRA is that person who adds another layer of a filter of what do we do to patients or what the industry in, meaning pharmaceutical companies.
Theodora Savlovschi-Wicks: Mm-hmm.
Maria Milas: What do we do? How do we investigate and how do we research and how do we test treatments that we're then going to get on the market? How do we test them on patients? But the way we test it, it also matters, which is one of the most important, actually one of the most important things. Is it, is it in a safe way? Are patients safe? Are patients informed? Are patients in a safe environment emotionally? from a scientific perspective as well, but also there in terms of regulation. ⁓ Does sponsor, does the does the investigator, does the hospital apply the regulation, but also from ethical perspective. So I would say the theory is that extra eye or extra filter that we add to our research just to make sure that we comply or that we keep it as a safe space or safe environment from all perspectives, from ⁓ ⁓ safety, ⁓ ⁓ ⁓ medication, ⁓ that could happen to the patients, but also from the perspective of does this patient know what they're getting themselves into? Do they know ⁓ the ⁓ might be, not just short-term, but also long-term? So having this extra pair of eyes that looks at the
Theodora Savlovschi-Wicks: Mm.
Maria Milas: data that looks at what's coming out, what's happening day by day to this patient in the clinical trial. That's what a CRA does. I would sometimes call it as a, it's not an auditor because we have that role who audits also what the CRA has monitored, but it's that first step of audit, let's say that we have in our conduct of clinical research.
Theodora Savlovschi-Wicks: Mm-hmm. An essential layer of support is what I call it.
Maria Milas: Yeah, ⁓ Even, would say even support and ⁓ compliance support and ⁓ filtering that ⁓ sometimes in a fun fact, I ⁓ got myself for the time a little office ⁓ just to ⁓ space. ⁓ might not very essential, but when you're organizing a conference for 250 people, you might need a storage space. Like where do you put 300 pens, 300 tote bags? There's just a lot of things you need to store. So I got myself a little office and it's in inside. I'm sharing the office with a private detective. So it's a fun fact. It's very interesting. We have very interesting conversations on the hallway. So it makes me think that if I
Theodora Savlovschi-Wicks: Mm-hmm. ⁓ This is definitely interesting.
Maria Milas: If I could draw a comparison with another role, sometimes it feels that the CRA is the private detective. It's sent by the sponsor. We have to be there by regulation, differently to a private detective. But what we're trying to do is that follow the data, follow the patient from the very beginning to the very end, following the regulation, following every step on the way and raising a flag or raising your hand whenever you see something that is outside. of the expected or allowed or norm.
Theodora Savlovschi-Wicks: Great parallel. And that's a great parallel. Another thing that you and I have spoken about and you're quite vocal in a lot of the things that you write and the things that you publish is obviously the unrealistic expectations that we currently tend to have on CRAs that are conducive of burnout. obviously monitoring backlogs, site file reviews, time pressure. Where do they come from and who's responsible for fixing it in your opinion?
Maria Milas: Hmm. There's so many elements to it, I think. ⁓ ⁓ long time, we would blame it on the metrics, right? We would blame it on, ⁓ this sponsor has unrealistic expectations in terms of how many monitoring visits we do in a month. ⁓ we would blame it on the CRO
who would want to charge the sponsor for as many monitoring visits as you could, because the more monitoring visits you do, the more monitoring visits sponsors pays and then
Theodora Savlovschi-Wicks: Mm-hmm. Mm-hmm. Mm-hmm.
Maria Milas: the budget just keeps increasing. So we would come up with this is the reason why, but that's not it. To me, it's a combination of not taking time to properly train our CRAs and especially consider there are many CRAs who come from an unrelated background, just like me, just like myself. So I don't just need to learn.
Theodora Savlovschi-Wicks: Mm-hmm. Mm-hmm.
Maria Milas: how to perform a monitoring visit, I need to learn the very fundamentals of how does the industry work? How do you develop a drug? What's the first step? What's the last step? What's the impact of my job? How do people communicate in this industry? It's such a different industry what's the language we communicate in? Or if I have a particular communication, what do I do with that? Do I have to file it? ⁓
Theodora Savlovschi-Wicks: Mm-hmm. Mm.
Maria Milas: It's so much content that we need to ensure that the CRAs have in order to then be empowered. So for me, it's a combination of a lack of the spending the time or taking the time or the effort of resources to train the CRAs properly. Then there's a unrealistic expectation on the many layers a CRA can pay attention to. So we're expecting a CRA to not just
Theodora Savlovschi-Wicks: Mm-hmm. Mm-hmm.
Maria Milas: have incredible soft skills building relationship with sites, of building relationship with ⁓ personalities, different expertise, also different ⁓ of experience people and bring this to reality, what I mean by that is we expect perhaps 25 year old CRA to have a great relationship in a little bit of a power dynamic, of course, with a perhaps 60 year old, incredibly, sometimes arrogant, very authoritative principal investigator, but at the same time have a great relationship with another study coordinator who might be extremely overworked, ⁓ no time for you, no time to follow up on a missing signature on some paperwork that you want, that you consider as the survey important. So we're, ⁓
Theodora Savlovschi-Wicks: I'm this.
Maria Milas: expecting from the series to just come trained with those soft skills. By this is the package that you need to come with. Have the soft skills, have the training, have the competencies, be okay with the stress that whether you want it or not, the fact that our day to every day is different, it's an added stress on you, whether you're traveling or not. Traveling, of course, adds even an extra layer of
Theodora Savlovschi-Wicks: ⁓
Maria Milas: you're just being more tired and being tired at stress on the body and on mental capacity. But every single day can be different. You never know if you're going to pick up your phone and you have a serious safety issue that you need to deal with right now, ⁓ or you have an email that says, Urgent, what the heck did you do? You never know. So that ⁓
Theodora Savlovschi-Wicks: Hmm. Mm-hmm.
Maria Milas: fear of what you don't know might happen, which is a reality, happens every day, because what we deal with, there's a responsibility in it. The impact of your work has a direct impact on the patients. So there is this extra burden as well on the expectations of what we want from the series. And I can going, of ⁓ were these little bit of
Theodora Savlovschi-Wicks: Mm-hmm.
Maria Milas: too high expectations on the CRA role come from. But I would also want to say that this is changing and I think the industry is changing, the role is changing in many shapes and forms and some of the burdens that we used to have five to 10 to 15 years ago, in many cases, that's not the case anymore. Now, obviously we'll have CRAs who are still
Theodora Savlovschi-Wicks: you Mm-hmm.
Maria Milas: in a more traditional type of environment in a clinical trial will say, no, I still have the same problems that I had, same challenges, same metrics. Yes, of course, as an industry, the change will come gradually. But as we're starting new clinical trial, more remote monitoring, more centralized, more supported by tools, all that is also alleviating a little bit the burden on CRAs. But at the same time, it adds a new layer of expectations, which is
Theodora Savlovschi-Wicks: Mm-hmm. Mm-hmm. Mm-hmm.
Maria Milas: adapt to these new type of more modern clinical trials.
Theodora Savlovschi-Wicks: So it's really one of the most versatile positions you could possibly have in clinical research. You have to adapt, you have to have the soft skills, you have to be pretty young and pretty cheap in what today's hiring market. You have to be able to travel night and day, you have to be able to retain a lot of the information, go through the SOPs in three weeks and then go to site on your own and have all the responsibility on your shoulders. Did I summarize that correctly?
Maria Milas: It really is. Very well and you did it in 10 seconds instead of me in two minutes.
Theodora Savlovschi-Wicks: Now talking about technology, so obviously you moved into clinical tech specifically because you wanted to get treatments to patients faster and you wanted to be part of that change. In your opinion, what are the gaps that you've seen working in clinical tech between the field and the tools being built for it?
Maria Milas: Mm. Hmm. The biggest problem I've is ⁓ lack of direct contact with the end user and ⁓ always speak of, no, our vendors they run user they run user interviews, they run a couple sessions of surveys ⁓ and discussions with our user, but it's not enough. ⁓ So many times I've observed and I even used to work with systems as a CRA, because as a CRA you get to touch every single system that you use in a clinical trial, that I would just think, why are you asking? Why is this a mandatory field when it's not even required by protocol? It doesn't even make sense. It's just completely unrelated to the reality
of the role. So I think that's one of the biggest problems of the industry,
Theodora Savlovschi-Wicks: Yeah.
Maria Milas: this tech bubble we have in our niche in clinical research because it's technology companies that only do or mainly do systems for clinical research. So it sits somewhere between what I call the real tech, real tech companies and pharma or zero companies is somewhere in the middle exactly. So the main problem is always if you're building a system, but you only have
Theodora Savlovschi-Wicks: Mm-hmm. The intersection.
Maria Milas: a group of five developers and two managers that have no experience or have no touch base with the the study coordinator, the PI, the patient, the system ends up being used by a patient. How are you going to design a system that is embraced, is adopted easily, the user then loves and that the user uses it continuously so that then you don't end up complaining about,
Theodora Savlovschi-Wicks: You
Maria Milas: They don't use the system. We have an adoption rate of 40% So I that's the biggest problem. We need people with expertise, ⁓ with the real experience, just on paper. The people who were serious 30 years ago, that's not the reality today. ⁓ not useful anymore in that scenario because industry changes incredibly fast and
Theodora Savlovschi-Wicks: for adoption. Mm-hmm. Mm-hmm.
Maria Milas: my experience from 10 years ago might be not relevant at all today. So if you don't keep up with that, and if you don't make sure that within your team designing and building these systems, you have real-world experience from right now, current one, that's the problem you're going to have.
Theodora Savlovschi-Wicks: Mm-hmm. I completely agree. And I think there is a lot of conversation around that, the right type of background and actually understanding in real terms what the end users pain points are in developing a product that addresses those specific pain are quite crucial, right? And I think ⁓ everybody that I with is pretty much overwhelmed with the amount of tech, with the amount of tools of which there are and they don't always communicate with each other. So then you end up obviously,
Maria Milas: Mm-hmm. Yeah.
Theodora Savlovschi-Wicks: duplicating your work quite a lot depending on the systems.
Maria Milas: Yeah, that is a very good point, Theodora. In the we always speak about this unicorn system at point that will just connect every system and that, ⁓ but that does exist yet, or we haven't managed to connect. We have the source data, what we call the electronic medical that usually sit perhaps sometimes in a
Theodora Savlovschi-Wicks: harmonize everything.
Maria Milas: little software built by a hospital and only they have access to it and they're completely refusing to give access or APIs or connect to other systems from the industry that is outside of their hospital, because it's not compliant and their procurement team will never accept that. So imagine a system that would have to connect with the
source data, connect with the end data capture connect with the patients, connect with the study coordinator, connect with the pharmacy, connect with the storage unit of the investigational product, connect with the transport vendors so that we know what's happened to the drug in the trust. There's so much to connect in this industry that the day we have that unicorn that connects every single vendor or every data point, then we've solved it. But we're not there yet.
Theodora Savlovschi-Wicks: So here's a, we'll launch the challenge to our audience then who's going to be able to come up with a solution that harmonizes the ecosystem of tech in clinical research.
Maria Milas: wouldn't that, that would, that would definitely solve a big need.
Theodora Savlovschi-Wicks: a lot of the needs. So in terms of, ideas and entrepreneurship, you're obviously you founded CRA Connect. So what made you come up with CRA Connect? What was the thing that made you say I'm going to do this and I'm going to do this now?
Maria Milas: pain. You know, I think we all use our experience to then build something. while I was a CRA, it all comes from back when I was a CRA. Now, of course, I love the job. I absolutely love the job. I love traveling to different hospitals. I loved having a a different task and different priorities every single day. I met so many people. I've met so many places in Spain that I would have never traveled to because who goes into a little town somewhere in Andalusia where you have like a little hospital with 10 patients, but you would never consider. But guess what? Maybe I've had the best paella I've had in my life just because you had the chance to go there. So I loved that. Plus obviously the
Theodora Savlovschi-Wicks: Hehehe.
Maria Milas: the impact of my role. But because I was traveling three days out of five, because I was already an experienced CRA so I would be always by myself, because when you would not be traveling you would probably want to be working from home instead of the office because somebody has to put the laundry, somebody has to do the groceries especially when you're always on the road. So I felt very isolated from the other CRAs in the industry. And at that time, when the idea sort of started growing, I was even a CRA in one of the biggest CROs in our industry. Even in, I don't even know how many CRAs we were in the company, but within my team, we were 45 CRAs in my team, local team in Barcelona. So we were huge, but ⁓ two of us would have the time one day in the office to grab a coffee and just chat. Because if I was in a monitoring visit, then you were. And if I wasn't in a four-hour remote site initiation visit, then maybe you were in an investigator meeting somewhere else. So we didn't have that space to connect and speak about the challenges and support each other and how are you dealing with this. So that's how it all started, trying to
Theodora Savlovschi-Wicks: Mm-hmm.
Maria Milas: bring a space or create a space where CRAs can share and can learn from each other, also without the eyes of the manager you. Because there's an aspect of the CRA role where at one point ⁓ come across the decision of, Do report this? Do I close my eyes to what I'm seeing at the site and we'll just deal with it later because
Theodora Savlovschi-Wicks: Mmm.
Maria Milas: there are certain things that sites might decide to do differently sometimes. And I'm not speaking obviously about non-compliances or big non-compliances, but maybe, you're, requesting the site to give you that document now, but they might say, take this document because, this is what we usually Is it, is it good enough? And then you would just close your eyes and say, this is what the site is using. So you would not push back. And sometimes
Theodora Savlovschi-Wicks: Yeah. Mm. It's good enough.
Maria Milas: Exactly. And you make that decision, but you know that if you bring this discussion to your line manager or to your project manager, they would say, no, no, no, no, In our study, this is what we're doing and this is what the sponsor, so you would then have to push back. having the access to another CRA to say, do you also work with this site? Do you also go with this? Do you accept this document? Exactly, and another CRA might say, I am, they've been doing this for 10 years. It's totally fine.
Theodora Savlovschi-Wicks: Have they said this to you as well? Yeah.
Maria Milas: Just argument or specifically say why you're using this document. This is how the site, this is their standard of proceeding with this documentation. And then it's totally fine. You don't need to push that back because it's not a mandatory SOP. So these little things that you just get from discussing with other colleagues, with other series in the same scenario, and sometimes not having to bring it to your line manager.
Theodora Savlovschi-Wicks: you Yeah.
Maria Milas: Cause it's it's a skill that you just ⁓ from experience. That's what impulse me to open the community first, which is the first product sort of that we opened. That was three years ago and it all started with just posting on LinkedIn and seeing that thousands of other CRAs ⁓ going through the same situation. they also wanted a space to chat and to mentor and to
Theodora Savlovschi-Wicks: the same.
Maria Milas: discuss and to open conversations and ask questions. And that's pushed a little bit to say there's a need for all of us here. Now, if a company like a pharma or a CRO or a vendor is not providing that space for us, well, who will? Us. So let's us create a space for ourselves where we can empower each other.
Theodora Savlovschi-Wicks: So if not us now, then who and when, right?
Maria Milas: Exactly. And create the space so that you yourself can have a voice in this industry. it's almost related to the biggest challenge that I see within the tech industry when we create our systems and we don't speak, we don't give a voice to the
Theodora Savlovschi-Wicks: be the change
that you want to see. Make the change that you want to see in the industry.
Maria Milas: users that will end up using our system. It's a little bit happens the same with the CRAs. CRAs don't really have a voice into what do we do with the budget that we have in a clinical trial. We don't have a voice of which vendors do we choose to have in a clinical trial. Do we prefer the CDC system? Do we prefer this other EPRO? Because it just makes our life so much easier, our lives and the whole site's lives. So we have that voice, but that doesn't mean we shouldn't have a voice. We should still be considered because the impact of the CRA, the influence of the CRA, the work, day-to-day work of the CRA has such a bigger impact on sites compliance, ⁓ efficiency, sites to work again with that CRA or with that sponsor. And also ultimately that an impact on the patients. And we forget about the influence of the CRA. So we had to build a place, a space within the industry where we have created a space to have a voice. And that's what ⁓ did opening ⁓ Connect Live 2026, so the first conference for CRAs. And there hasn't been something like this in the industry ever before, but not only it was time, it's also incredibly needed to have the industry here.
Theodora Savlovschi-Wicks: Mm-hmm.
Maria Milas: what CRAs do, what we need, what we need to be empowered, what we need to have more efficient and better clinical trials. And I know that, of course, technology now is adjusting and adapting and changing completely the role. But that's also the point. We need a united space where we have that conversation of how do you, technology, impact me, my role as a CRA? I know you still need CRAs.
Theodora Savlovschi-Wicks: Hmm. Mm-hmm.
Maria Milas: So I'll have to adjust and adapt. How do I have to do that? Let's have that conversation.
Theodora Savlovschi-Wicks: Absolutely. So what I'm hearing you say is basically that through the CRA community, you've created that space where if the CRA doesn't have the actual pre-made space at the table, this is the space where they learn how to build that space at the table and how to have their voice heard and how to better communicate up the chain on what their needs are, which I think, we can probably look at this from so many different functions across the clinical research industry as a whole. ⁓ I there is a
Maria Milas: Hmm. Yeah.
Theodora Savlovschi-Wicks: it is a theme that I hear often when I speak with people in different functions that perhaps there are a multitude of ⁓ experiences, that they would love to talk more about that they would love to develop on and feed up the chain, but there isn't the space to do so because this is what we do. This is what we've done. This is what needs to be done. I don't have time to listen to you. So from your experience,
Maria Milas: Yeah. Yeah, yeah, exactly.
Theodora Savlovschi-Wicks: creating this community and obviously, you there are thousands of members worldwide and it's incredible what you've built in such a short space of time. So I think that's testament not just to, your excellent ideas ⁓ and marketing ⁓ but also why hasn't anybody done this before? So you're obviously, the right person with the right passion at the right moment. ⁓ So from your experience, what do CRAs most of right now?
Maria Milas: Yeah.
Theodora Savlovschi-Wicks: Is it knowledge? Is it validation? Is it a forum for their voices to be heard?
Maria Milas: It's a number of things. I hope, I genuinely hope that there are especially sponsors and, hearing this podcast because I'd love to, I always say that I love to represent the CRA voice just because I love to hear what we need and somebody has to speak out loud because we don't make ourselves heard, then ⁓ the will never be heard. But what CRAs need is.
Theodora Savlovschi-Wicks: Mm-hmm.
Maria Milas: First of all, education. And by education, I don't mean, don't give us another 100 slides presentation on how to develop a drug. We know that. Don't give us another GCP training. You know what? Most CRAs do GCP trainings themselves just because they understand the need or the importance of having those certificates. What education we need is, what's the state of the industry? Where's the industry going? How's it changing? How, by what's impacted? What are the trends in the industry? Do we see more sites? Do we see more new sites? Do we see still the same old sites, big sites, and where we have more and more clinical trials? We also want to know about these things. We want to know about how's it impacted by DCTs, AI? How's it impacted by automation? How's my role going to be impacted? What do I need to know to then be a successful CRA, successful in my job? Because then I will also be a successful employee or freelance or individual contributor. So that knowledge, we need to also be brought into the conversation of the industry as a whole, as a body. the first thing we absolutely need. The second thing we need is invest a little bit into us, the series, because, every company does or should have a personal budget. And ⁓ this way don't only ⁓ ensure that retain these employees, but also you ensure that these employees are staying up to date, are staying It's growing, it's developing skills that in the end these skills will of course be applied within your own context of the company. So it's in your benefit, I would say. But we also want to grow as people, as professionals. We don't want to stagnate and then have the fear that within five years we won't be relevant because we didn't know how our role was changing and adjusting.
Theodora Savlovschi-Wicks: Yeah. You don't know what you don't know.
Maria Milas: Exactly. So tell me, tell us what we don't know. That's what the biggest need is, I would say, having that conversation of, if I were to make a comparison, you can't become a CRA if you've never heard about the role. And most, let's say, graduates have never heard about roles in clinical research when you are
in academia still, in university. So you can't become Siri if you don't know about the role. Now for us, I can't become the monitor you need or the industry needs if you don't tell me what that is. Tell me what's expected from me. How's it changing? I want to learn, but I don't want to learn through the same two hour presentation that I'm forced to click next, next, next. And there's a lot of texts. And the only thing it's telling me is how to do my job now, but prepare me.
Theodora Savlovschi-Wicks: So no, that's an option. Absolutely.
Maria Milas: me that insights into what's expected from me in the next five years. And then let's look with a personal development plan together with the hiring manager, with the company, how are we getting there as a whole? This way we would feel part of the team, part of the conversation, part of the industry.
Theodora Savlovschi-Wicks: So communication, inclusion.
Maria Milas: Yeah. Education, learning, also in networking space, to be very, very honest for us, we are such an role because we just travel or we're doing monitoring activities and we're, ⁓ within the of a screen. And we don't so often have the chance to do networking with not just...
Theodora Savlovschi-Wicks: application. Mm-hmm. Mm-hmm.
Maria Milas: other, let's say, CRAs as well, because we also need that, but with other roles, roles that perhaps we then get the inspiration of, I want to develop into this. I want to become a study manager. I want to become a study startup manager. Actually, I like more people managers. I want to go into line management. ⁓ networking opens eyes and creates soft skills as well. So education, communication.
Theodora Savlovschi-Wicks: Mm-hmm. Mm-hmm.
Maria Milas: Inclusion and of course networking is just one more layer into all of them.
Theodora Savlovschi-Wicks: inclusion. Absolutely and I think perhaps if I may add to that because obviously we're in agreement with so many different things you and I. I think when it comes to building one's career in today's society, in today's job market, it is perhaps more important than ever that we know what options that are available and that we understand that we don't necessarily have to carry on through that you
Maria Milas: Thank
Theodora Savlovschi-Wicks: matrix that was given to us a decade ago of hold on to your corporate job for 10 years in the same sort of role will notice you and I think it's up to us as individuals as well to kind of go and ask you know and look at where we can diversify our skill set so that's I love the idea of the community and obviously I love being part of this ⁓ as if you you first started monitoring what would you say is the
Maria Milas: Mm.
Theodora Savlovschi-Wicks: the main piece of advice that you wish somebody would have given you when you first started.
Maria Milas: Oof. more than advice, I ⁓ I wish someone had told me a fact sort of just for, my ⁓ release little bit for, releasing a little bit the stress or the fear I had. I wish someone had told me that in this industry or in this role, soft skills are much more important than the hard skills than the technical competencies. ⁓
Theodora Savlovschi-Wicks: Mm.
Maria Milas: because it's I did spend more time or it required from me to practice more of my soft skills to be successful in my job, in creating the relationships, in communicating with so many different parties on a different, on a daily basis, on paying attention to the little things or understanding the communication, the nonverbal communication.
Theodora Savlovschi-Wicks: Mm-hmm. Mm.
Maria Milas: that you would get at the sites, that you would get from the study coordinator. That is what a CRA is even expected to do. But you focus so much at the beginning on, okay, so show me, how does the protocol, what is the protocol? What are the sections in the protocol? And of course that's important knowledge too. But if you don't come with a set of soft skills or you forget about them and you just focus on
Theodora Savlovschi-Wicks: Mm-hmm.
Maria Milas: data point check, your role, it will be harder for you. You will have added stress, added burden. And I wish just someone had told me that it's, you'll get the technical things. You'll learn the competencies, but the soft skills is just something that you want, only you can work on ⁓ and learn. So don't forget those.
Theodora Savlovschi-Wicks: Great advice. Thank you for that. And if somebody who's listening right now is sitting on an idea, to know, for any company or a new technology or new community, a course, a pivot into a new position, what would you say it's important for them to hear now to kind of give them that go and do it?
Maria Milas: Mm-hmm. Mmm. That's a very good question. ⁓ I believe the success of something, obviously, big part is your knowledge and ⁓ whatever. ⁓ even part for me is the consistency. So for how long are you going to keep pushing until that project at the beginning or that idea becomes a project, the project becomes a company? And it becomes the company starts with a little profit and then starts having more. So it's just a matter of also time. So I think my tip, not tip, just the thought that I would have at the beginning is whatever project you want to start or company you want to start, if it's not directly related to your passion, it will be very hard to sustain it and maintain it for the... amount of time that it needs so that it turns from just a project into a company or into a scaled project so that you can in the end not just scale it and grow it but also live off of it because at one point we also need to sustain ourselves somehow and that only comes exactly and that only comes with waiting the right time and I've seen many
Theodora Savlovschi-Wicks: forgot bills to pay. Mm-hmm.
Maria Milas: founders or great ideas that come up in people and then they might try it for three months, six months, one year, one year and half. But sometimes the results don't come that fast and you need
to keep pushing. And if your project and what you're doing and what you're pushing is not your passion, it's very hard to push until you don't know when.
Theodora Savlovschi-Wicks: Mm. Mm. That is such fantastic advice. I think there is probably the consistency is obviously something that comes up very, very often in any entrepreneurs conversations, right? You have to keep at it if you believe in it. But obviously, if it isn't your passion, and if you don't truly believe in it, then it becomes much more stressful than perhaps gainful in any ways. ⁓
Maria Milas: Yeah, you'll have days where you'll think you cannot do this and you will not pull this off. And then you'll have days where you think, I can pull this off. ⁓ if it's, ⁓ ⁓ ⁓ standard fact, it will happen. You must have as an entrepreneur days where you'll feel up on a high and you'll say, this is great. This I'm, it's working great. I'm so happy I'm doing this.
Theodora Savlovschi-Wicks: There's days and days.
Maria Milas: And then there's days where I'll say, maybe I think I overdid it. I think this is over my head. I think I might need to Exactly. And that is the stress of an entrepreneur, I believe. So it's much easier to overcome that or to live with that when are passionate and you believe in what you do, because then the highs are very high. So it compensates a little bit the low days. ⁓
Theodora Savlovschi-Wicks: What did I do? Absolutely, I think you and I have obviously have discussed about this before and I think we're very similar in that regard and there are days when know we're on top of the world and everything is fantastic and this was the best idea ever and I'm so proud of doing it and are days where I question my life choices and whether I'm going to live in a tent in a few months time. And then talking about you know the future obviously there is the conference coming up can you tell us a little bit more about the conference where the idea about the conference came from and
Maria Milas: Yep. Yeah. Mm-hmm.
Theodora Savlovschi-Wicks: What can we expect apart from obviously hearing me speak?
Maria Milas: Of course, of course. So I'm ⁓ incredibly excited about this that we're hosting in May. ⁓ So we're getting together for the first time in the industry, 250 CRAs over, I would say mainly Europe. We do have some coming from the US too, but it's quite expensive and hard to go across. So the world, so we're mainly CRAs from Europe 250. We have two days panel discussions and presentations of ⁓ exactly those, that information that we need about the industry, about the role, how to grow, how to develop. We're learning about, ⁓ the how's AI impacting our industry? How's it changing? We're learning about the skills that the CRA needs. We're learning about career growth. You'll know that I have a session on career development for CRAs, which I think it's incredibly important to hear it directly from someone who's been empowering CRAs to change or to get the job or to get those jobs that they were looking for. So having that information firsthand is important. So we're having two days. On the second day, we have a full two hour networking and career fair. which I love to be able to provide this space where we can connect over 15 minutes and we use matchmaking and then according to whatever you want, if you want any opportunity, if you want just networking, you want to just connect with another CRA, if you want mentoring, you can get five 15 minute conversations within the setup of the conference. And it's going to be amazing. We have come speakers from sponsor, from CROs, from consulting companies, recruitment. We have from all sorts of layers of the industry. And I'm very, very looking forward to this event. And it's in May, 12th and 13th of May in Barcelona. And the plan is to do it every year so that we have a space in the industry that is regularly for ⁓ And we know where to get together and where also the industry can come to meet us.
Theodora Savlovschi-Wicks: Absolutely fantastic. I'm really excited. really look forward to being part of it. And I can't wait to see some sun as this is ⁓ filmed the morning, yet I had to put my lights on. ⁓ thank so much, Maria. It has been a real pleasure hearing you talk so passionately about the CRA and the community that you have built. And it ⁓ is a pleasure for me to be part of the community and to support with
Maria Milas: Yeah. You will not miss that in Barcelona in May, definitely, because dreams do. Thank you for having me.
Theodora Savlovschi-Wicks: with your endeavors as well. So thank you so much.
Maria Milas: Thank you for having me, Theodora pleasure.