Embracing Changes to the Clinical Research Workforce

Chapter 1: Setting the Scene

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Hi, everyone and welcome back to the “Advarra in Conversations With…” podcast. Today we’re going to be touching on the very important and timely topic of workforce challenges in the clinical research industry.

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I’m Wendy Tate, director of advanced analytics and research optimization at Advarra, and I’m joined by David Vulcano. David thanks for joining us today, why don’t you introduce yourself?

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Sure! Hey thanks for having me Wendy, I appreciate it. So, I’m David Vulcano my day job or my Clark Kent job, so to speak, is, as the Vice President of clinical research compliance and integrity, for HCA healthcare.

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But at night or evenings and what not I get to take off my Clark Kent glasses put on my Superman Cape, so to speak, and be the honorary president for the society of clinical research sites. So SCRS is the Trade Association for clinical research sites, they have about 9500 sites across 47 different countries and that’s what a lot of the topics of conversation today will come up from what the sites are experiencing around the globe.

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We got to touch base briefly actually at the SCRS oncology conference that just happened a couple of weeks ago, and workplace and workforce management was definitely a hot topic there. So why don’t you start there and kind of give us a give us an overall feeling of the impact of the great resignation, the great reshuffle.

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You know there’s been a lot of turnovers at the site side, especially at the patient or subject facing position of clinical research coordinators.

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You know, probably about seven or eight months or so ago, this kind of started and the trend just seems to be escalating so a lot of the SCRS Member sites and even non-Member sites are talking about that the CRC turnover is two to three times what it used to be and a lot of that is Just your overall stuff of the great resignation, “just want to exit the workforce.”

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or “hey I have better work at home from options” which work from home as a research coordinator is kind of difficult so there’s been. You called it the great resignation great reshuffling some people call it the great poaching

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Because a lot of the research coordinators are getting recruited by the CROs and the sponsors to be monitors.

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But hospital systems are doing the same thing, and my hospital system that I work with is no different you know we have NICU nurses, emergency room nurses, ICU nurses that are exiting the workforce for other options or exiting that role.

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And many research professionals are nurses, so you know they’re getting lured by large sign on bonuses, double the salary, work from home, refer a friend bonus and things like that and a lot of site managers are complaining that they’re not even giving two weeks’ notice anymore, a lot of these folks it’s “hey it’s a $10,000 startup bonus if you’d start tomorrow”

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So, you know, instead of giving two weeks to try to transition it’s a phone call of “hey, I’m not coming tomorrow” so yeah it’s been a significant challenge for sites that we’re trying to work together with our sponsors yarrow and other solution provider colleagues to figure out, how can we get through this time.

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yeah and I can imagine you know with those types of challenges just it’s greatly impacting the clinical trial itself, which then of course impact sponsors and CROs.

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So, what are some of the short-term solutions that you guys are trying and working on or you’re seeing in the industry, either coming from sites coming from sponsors or CROs to maintain continuity in this in the clinical research? I mean we have data integrity to worry about, we obviously have participant safety at top of mind So how are we dealing with this in the short term?

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Right, right well you know we at SCRS we heard a lot of the voice of the sites coming through this and

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We decided that two deliverables were due. The first was an open letter to our sponsor and CRO colleagues, just saying hey, this is what happens when we lose a coordinator. And yeah we don’t want to shackle our coordinators to their desks, you know we endorse them getting a career path and to the extent we don’t have career path for them.

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We need to respect that they want a career path on that, so you know we’re not trying to have draconian efforts of non solicitation non competes you know. You know, things along those lines, although you know those things are often discussed, but it does have that impact on study continuity mean when so part of the open letter.

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To our sponsor and CRO colleagues wasn’t necessarily finger wagging. But it was more along the lines of here’s what happens at the site level when we lose a coordinator and they’re recruited away to be a monitor or just lose a coordinator in general, so yeah I mean the first thing that is on the sites radar is “oh my gosh what visits do we have coming up, that we need to backfill” you know if it’s a small site, they may only have one or two coordinators and they just don’t have the staff to backfill those visits.

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the issue is, we have safety visits coming on no staff to do them the ethical thing is to drop those subjects from the protocol so we’ve lost that set of subjects.

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Another thing that that’s tough to quantify is the retention, you know many coordinators have a real bond with the subjects, because he spent so much time and so much energy and emotion with the trial with that coordinator, they really make a connection to the subjects and when the one coordinator leaves

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that subject is somewhat demotivated to continue in the study or you know, not to say that they’re all going to quit but, but there is a factor in that have you know “gee I really like that coordinator,” I mean I have coordinators that tell me that if they’re going on vacation during one of their subjects visits, the subject doesn’t want to come and do the visit with the other coordinator, they just wait till they’re back from vacation so when they when they leave all together that that’s another thing.

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Another aspect is that sites have to look at their study portfolios that they have now, and say “hey can we afford to have to come even staff 810 studies open, can we have staff two or three studies open maybe we should close down some of these studies what studies.”

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Are not recruiting well what studies are we having real friction or trouble with the sponsor or CMO on what studies have had so much scope change and what studies aren’t paying us on time, you know those types of things as well we’ll just you know close out those studies.

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Other resources for startup you’re less coordinators, you have less time to recruit less time for startup and less time for quality. Then you bring in a new coordinator and these are typically people that don’t have experience you know coordinator is oftentimes an entry level position into this, so we don’t have the luxury of saying we want two years’ experience so most coordinators are people that are new to the industry and we train and it takes six to 12 months from what most experienced site manager say to get that coordinator fully up to speed, so that they’re equivalent to the coordinator that they replaced.

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So that’s some of the impact in our open letter to sponsors and CROs and the ask was to hear us out on this. And let’s work together for this, we respect that sponsor CROs IRB solution providers, all these folks are going through the same macro-economic issues.

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We respect that, but we can’t keep robbing from each other, this is not working, so what other types of things can we do together we don’t think we can pull out of this on our own, other short-term things, where we, as a site industry do have an obligation to do the best we can even without our sponsor and zero colleagues helping us with additional funds or resources or whatnot

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was in a toolkit that we put out to our Member site so many of our sites large site networks generously shared a lot of their best practices in this area, a couple of those practices were.

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You know, one started holding “stay interviews” so rather than waiting for an exit interview when they’ve already quit sit down with that coordinator and say hey.

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we’re not talking about our KPIs or deliverables our goals or whatnot all we want to talk about right now is, why are you here and why are you staying and what would make you want to leave and that’s been interesting and they’ve learned a lot about having this new dialogue with their staff they’ve learned a lot about them.

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One example came up of the mother that said hey I need to leave here at 2:45 every day because, if I don’t pick up my child from the preschool at exactly three o’clock it’s like $5 a minute that I’m late. And you know subjects are always late extra paperwork monitor calls on the phone and whatnot that’s always a problem, so it was “hey wait. Why don’t we just get a service that you trust and whatnot to be there to pick up your kid and work that?” so you’d alleviate this. and employee was oh my God that’d be fantastic, so these types of creative solutions to understand why would somebody want to leave.

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so Those are some short-term things that that some sites are doing until we can kind of get to some stability.

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yeah there’s a lot there I heard let’s see I heard contingency planning which we’ve all learned in the last couple years that you can’t plan enough for you know contingencies emergency situations. portfolio management, which I definitely want to get back to you here In just a second I heard training in there.

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But also, then you know some maybe non-traditional human resources. And, and so, so many different things that our programs are having to think about when I think about a lot of people who are clinical research managers or directors of offices or departments, Not necessarily trained in so you know all of a sudden they’re coming up with these skill sets that Oh, by the way we know you were a great coordinator, we promoted, you have to manager, maybe now you’re a director Oh, by the way, here’s all of this.

Chapter 2: Pipeline Impacts

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Basically, project and people management that you know you get to pick up off the cuff, so some really interesting stuff coming out of that, but I want to get back to the portfolio management perspective. You were talking about open studies visits close outs, but one of the things I heard at the conference that was really interesting from the sites is also thinking about future pipeline.

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And that the lack of coordinators isn’t just affecting studies that are open it’s affecting the studies that might become open, the study activation pipeline, and one of the quote unquote easier places or maybe we’re kicking the can down the road to hold is to not open protocols to help with this shortage why don’t you talk about that a little bit and what sites are doing to help think about the pipeline, not just today but six months, nine months 12 months from now.

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yeah I know it’s a great point, Wendy because, the challenge of just maintaining the existing safety visits and study portfolio and whatnot is key, and like I said so many sites are looking at which one’s going to close.

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Because it’s too much of a drag or I just can’t maintain the quality that I want to have because you know, even if I have a new coordinator, they’re still new, they may not be able to handle complex studies, I have to have other people supervise them, etc., etc.,. But the new studies are key. Now an interesting thing was it in our survey that we had done with sites to gather some data around this.

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And, it was asked to the sites, “What can the sponsors and CROs help with this?” of course, the number one everything else was we need budget increases. The payrolls for these folks to retain them to compete with the CRO salaries and the hospital salaries.

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Has gone up an average of 30 to 50% year over year for many of these sites and they didn’t have the kind of margins and existing but this to do that, that and all the inflationary pressure pressures which you know, is a completely different topic than the workforce challenges.

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But in that scenario there other ask that the second most common ask was, we need to make sure our pipeline is still coming forth.

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And I’ve talked to many sites, and I say why don’t you talk to the sponsors and CROs oh my God, no, no, no, I can’t tell them the problems that we’re having with us because Then, then then they’re going to shut us down or they’re going to shut the study down or they’re not going to give us the next study.

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And we need to get past that and up encouraged many sites to say listen we’re in this together, I mean we really truly are in this together. The sponsors and CROs are just as much invested interest in study continuity as you do, if they don’t get the drugs approved.

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The CROs can’t get the study started and going that’s a burden on them too, so this is a problem we all are sharing this problem and we can come together and solutions, but it starts with an honest discussion and an open discussion and I’ve even talked with sponsors and CROs and encouraged them

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call your site and talk to them about this issue, not the other KPIs and all the other kind of stuff make a special point to call the sights on this. I’ve even told sponsors hey if you’re using a CRO you call the site directly, and bypass the CRO to see if you know there’s dialogue that you can have that unfiltered from the CRO that’s coming in, so that we can kind of share this, because otherwise.

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All the medical progress that’s going to slow down, we did so many great things and did it so quickly and fast during the pandemic for covid related stuff, but this is concerning to a lot of sites, because they don’t feel that they can adequately do the studies that they have much less expeditiously start and plan out future studies.

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yeah I love that communication. I’ve talked to several sponsors and CROs that we’re collaborating with as well and that’s a tough question for them is, how can we help our sites? like we need our sites for so many reasons we want them to be successful, we want them to be resourced and so.

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I love that you brought that up from the site perspective to yes talk to sponsors and CROs sponsors talk to sites have that dialogue, because we are all in it together, and there are a lot of ways that can be helped, but if you don’t have communication and transparency, you can’t solve the problem, because you don’t know what that is you’re just kind of shooting in the dark and guessing at it.

Chapter 3: Long-term and creative solutions

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And so, you know, taking a look into that, how do we do more long-term planning, how do we move this from a short-term problem to have a long-term solution.

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thanks for bringing that up, it is important point, I mean we, at SCRS, have done a survey to get some data around this and a couple of the questions well, one of the key questions in the survey was, what can sponsors and CROs do?

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Of course, the number one answer was “hey we need some study funds, you know, we need to change our existing budgets, because salaries have gone up 30 to 50% for our coordinators.” There’s no margins and existing budgets for that, so we you know we have to have an honest discussion about that because of the salaries and the inflationary pressures rent in some places is doubling in areas with the second most requested thing was the study continuity and you know that “please don’t shut down the pipeline of new studies we may not be ready for them yet.

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But please don’t shut that down.” I talked to many sites and many of them are actually scared to bring this up to their sponsors and CROs because they’re scared that they’re going to shut down the studies, or not give them new studies and you know, we are in this together in this concept we’re all facing similar macroeconomic issues.

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So that assuring or reassuring the site that we’re not going to shut down new studies for you, we realized that this is an issue that we have to solve and get past and work together get past, create some study continuity plan for existing studies, but then also get assured that there’s continuity of new studies flowing to those sites, because they are, they are scared that

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You know, they’ll be prejudiced against if they bring this up. So, we’ve encouraged sites to bring it up to the sponsors CROs and encouraged CROs and sponsors to call the site’s directly on this issue, how is workforce affecting our studies.

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How is it you know, is it more money is it temporary staff, is it can we alleviate something from you, is there a burden that we’ve put on you, that we can alleviate, so that you can focus more on recruitment and retention of subjects, or you know getting workforce up to speed a lot quicker.

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One thing I think that this might also be helpful from sponsors and CROs is they do a lot of training, they have access to training that they can provide new staff or other things, so you know if sites are having issues, having that conversation to say hey we might be able to be able to bring some people on.

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Maybe they’re really fresh like, Do you really need two years to be a CRC? Like in times like this, I think about coming from academic medicine and I had a couple of managers and I’ve talked to other institutions, who have done a similar method where they’re like we’re an academic institution, we constantly have a revolving door of undergraduates wanting research experience, people who want to go to Med school, people who are here because of a different situation where they know they’re only going to be here for maybe two or three years, so they would like train them

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On the job, regulator, like get them up and going entry CRC, data entry, those types of things, knowing that it was kind of a short revolving door, but would get some really great work out of it, so you know, having some of these internal processes, where we can say hey maybe it’s not the traditional.

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You have a biology degree, you have two years’ experience you come from a health system, maybe you’re a phlebotomist or something like that. How do you see maybe some Nontraditional training, either from sponsors or CROs or from systems, academic systems, health systems, maybe train out the next generation, so that as we’re getting through the short-term issue where hopefully some temporary staffing or maybe some funding boost for studies, how do we, at the same time, say we’re going to feed in the next generation pipeline, how do you see sites addressing that?

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Yeah so, so sites have done several things in this area. Some sites have started these types of mentoring programs, onboarding programs for a couple reasons, you know number one you know it would shorten the time from when they are hired to when they’re fully trained, I mean six to 12 months to get up to speed of the previous coordinator needs to be shortened so they have reached out to some universities and even if it a university hey.

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Come shadow us for a little bit we don’t hire you, but just come shadow us for a week or two or three or so see if you like it. Because that’s one thing, and this job’s not for everybody to be a research coordinator, people do this and.

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We’ve had people that got it and a week later, said this isn’t for me at all, you know I thought I was going into see patients not do 90 hours a week of paperwork, so you know it’s not for everybody, so it gives them a realistic job preview and then the site gets the cherry pick you know hey these are good these didn’t and we’re starting to see some classes of individuals that have gone up.

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They’ve also looked at nontraditional things so we had one site, brilliant idea was during the COVID pandemic; a lot of hotel staff concierge staff were laid off, they weren’t needed. They hired on the hotel concierge staff. Why? they didn’t have clinical trial experience, but you know what they did have: That experience in customer relations and solving problems for people, you know hey, how can we get you a ride from here to here and then here to here when we need you know.

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The overall arching thing we’re starting to see on the whole two-year experience thing. A lot of universities are starting his bachelor programs or some other certificate program in clinical research that they have developed training courses to onboard so that it’s you don’t need the two years’ work experience I have a degree and 160 hours of volunteer experience or other types of internships and whatnot so.

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hey, we’ll count that and we will get you up to speed to be a monitor, a CRP is working on a lot of these programs to try to alleviate this whole myth of you have to have two years’ experience before you can be a monitor. So hopefully as, one big pharma does others tend to do.

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And with the success of this program that they can look for alternative paths to become a monitor rather than robbing him from the other CEOs or nicking away the coordinators to go up to that monitor position it kind of opens up the applicant pool, so to speak.

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I love the story; you gave about the hotel concierge and customer service and because I think it also highlights the expansion of what clinical research jobs really entail. in a previous life I worked at the IRB and our running joke is nobody goes to college to work at the IRB.

Chapter 4: Looking Forward: Embracing the Next Generation

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Like you know you just don’t. You know you’re starting to see degrees and regulatory and all that kind of stuff now, but nobody goes in as an undergrad and speaks. Oh, my goodness regulatory ethics that’s my jam they kind of fall into it and when they do a lot of them love it and it’s great and that’s why we have a booming industry of these people who do it.

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But I’m excited that with a lot of the education and information that’s come out with the COVID pandemic trial, the vaccine trials and those types of things that we’re showing that clinical research isn’t just a doctor or a nurse or a pharmacist or a lab tech.

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In all of those different things, and even start, I want to see it start getting down into the high schools and middle schools, that’s when we need to get to these people to say hey you want to work in research like that’s going to be a really great pathway for you, and this is all the different ways that you can do it so. You know I really hope that we’re going to be able to see you know, a drive towards those different things which can then of course help with this move to more hybrid work, we had the Advarra report come out last year on workforce that did talk about the vast majority are going hybrid.

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If not completely remote that was that was still kind of a niche area. But a lot of institutions, whether their sites or sponsors or CROs are looking to be more hybrid

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really interesting to see how hopefully some of the things that have been kind of we were driven towards in 2020 due to the need to actually lock down. we’re seeing pains from that now and 2021 and I would say, even more so in 2022 with the great resignation, the reshuffle the everybody is trying to redefine their workforce.

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I’m encouraged for 2023 and beyond that all of this communication with the sites works that SCRS and ACRP and others that you mentioned, are doing to bring these groups together to encourage communication, transparency can really help solve this issue, but would love to give it back over to you, David

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yeah I mean I too am very excited about this, I mean what an interesting time that we have with COVID I mean the entire planet was looking to the clinical research industry What are they doing on this, you know and we had our 15 minutes we had our air time on this. So now is the time to get people excited about it

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in this area, what I understand about you know, especially most resonating in this younger generation or the next generation of workforce is they really want to work for something they believe in and they will sacrifice, they don’t have to be paid as much

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If they believe in leadership of the organization and believe in the mission and they’re very mission driven, more so than then perhaps my generation of the gen Xers and baby boomers. What greater mission you’d be hard pressed to find a greater mission

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the health and wellbeing helping people live longer happier healthier lives is among the top missions out there. So, we can tap into that with the culture of this next generation and say hey do you want people to live happier healthier longer lives. You know, higher quality of life throughout their times, this is the industry that does that

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Well said, David. Well thank you so much for joining today’s episode of Advarra in conversations with… it was really great to sit down with you, virtually and talk to some of these issues that are going on some short-term solution, some longer-term planning.

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And really giving such a positive outlook to what seems to be a desperate problem into really what I think is going to just continue to enhance the clinical research enterprise and really make us bigger, better stronger so that, as you mentioned, we can have a healthier and happier public Health population, so thank you so much appreciate talking with you hearing about the work at SCRS and thanks for joining me today.

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Wendy, Thank you so much, thanks for having me I really appreciate it

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That’s all for this week’s episode thanks everyone for listening, if you enjoyed today’s episode, please keep a lookout on Advarra’s social channels and on Advarra.com for our next episode.

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