Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Capacity

Sandy Smith: 

Good morning. Good afternoon. Good evening, depending on where you’re calling in from. I would like to welcome you to the WCG three-part site webinar series, and today’s topic is going to be thriving in clinical research, overcoming common challenges as a site. We still have a number of people joining us, but so thankful for your presence here today. My name is Sandy Smith, Senior Vice President of Clinical Solutions and Strategic Partnering, and we’re really glad that you’ve set aside some time today to join us to talk about thriving as in clinical research sites. We’ve certainly seen a lot of tumult over the last few years, and many sites are achieving that new state of rebalance. Others have action plans in place to get there, but sharing best practices is always a great way to learn from others. So, joining me today are two of my WCG colleagues, Jamie Harper. Jamie is vice president of site solutions and engagement here at WCG, and Emily Bornazian. She is a site service specialist here at WCG, but both come with tremendous depth of site experience. So I’m sure that you’ll really appreciate the comments and the advice that they’ll be sharing with you in today’s presentation.  

So, looking at what we’ll be talking about today, this is continuing our trend of the past two webinars, where we’re sharing information from the WCG 2023 site survey. However, as we are nearing the end of the year, please do be aware. We will update that survey in 2024, and look forward to your participation in that. We’ll also be talking about embracing anticipated turnover. As I mentioned earlier, a lot of tumult in the last few years, and I don’t think we’re at the end of it yet. And it’s just part of our normal day today. So how we respond to it can make a big difference. We’ll spend some time talking about overcoming site capacity challenges, combining technology with people, and then, as always, eager to be able to respond to your questions. I do want to thank those of you that did send in questions ahead of time, and please know that you can use the Q and A to put questions into that feature that we’ll respond to likely at the end of the presentation.  

But to get us started, we’re going to find out where you’re calling in from with our first polling question: What type of site or what type of organization do you represent? Are you joining us from a site, which could be an academic medical center, an integrated healthcare delivery system, a community hospital, perhaps a site network or physician practice, an independent site, or are you joining us as an industry partner, sponsor, CRO, or other? Okay, wonderful site representation. Thank you for joining us. And in addition, we do have some of our industry sponsors joining us as well. Appreciate that. So again, we we based this three part webinar series largely on responses from you, those of you that responded to our survey early in 2023. We had over 500 clinical research sites that responded, and giving us some important information. If you’d like to download a copy of this report, it is available on our website. Go to www.wcgclinical.com and you’ll see an option for our site challenges report.  

Now, looking at that data, who responded? Showing you that in graphic form, 31% of the respondents were research administration staff, and we had about 23% that were CRCs and clinical research nurses. Looking at the types of organizations that were represented, almost 40% were respondents from academic medical center. Although we had a great representation from physician practices, 17% And as we look at the trial volume that these sites were managing, over half of all respondents were operating more than 26 trials at a time, and knowing the number of large academic medical centers and site networks that responded, we know that obviously there’s a fair representation of those that are managing well over 150 trials at a time. So, as we see here, the results probably not startling to you that issues that have been issues over the past few years remained in 2023, with site staffing and retention as the number one challenge that sites were facing, topping over 60 percent, and in past webinars, in case you weren’t able to join us, we did address the second highest enroll, second highest challenge, which was patient recruitment and enrollment, and we also addressed study startup on a previous webinar. But also acknowledging that in 2023, we added complexity of clinical trials as an option, and that did tie for the third slot. These issues of site staffing and retention were both at academic medical centers as well as non-academic medical centers. So by far the leading issue at all research sites, And then, when we look at staff turnover at AMCs versus non-AMCs, we saw that it trended a little higher at academic medical centers. So, if we looked at a turnover rate of 20% or higher, academic medical centers reported about a 39% turnover again, 20% and higher, and your non-academic medical centers were at 29% But then another way to look at it is the under 5% and you can see that the non-AMCs certainly had that smaller degree of turnover. So in many ways, the tumult continues.  

We also wanted to make mention of trends that we have been monitoring at WCG on U.S. investigators participating in clinical trials. So what you see in this bar graph is the blue bar representing the number of U.S. investigators, and then the pink being the trial starts, and the alarming concern for us is to see the market reduction year over year, except for 2020, when we all know the public health emergency really brought a number of new investigators to help us with the many COVID trials that we’re undergoing. However, when we got into 2021 and 2022, seeing the declines continue, and the WCG knowledge base or data intelligence shows us that in 2023, approximately 45% of physicians participate in only one clinical trial and don’t come back for a second. But we also queried folks in our site survey on investigators, and did they see any change in physician interest or availability? And it was consistent, showing that about a third of the sites did report that they had less physicians, less physician time, or less physicians available to assist them with clinical trials, so as we look at staffing and retention, it goes well beyond the research team. Certainly includes our principal investigators and our sub investigators, and overall contributing to some of the site capacity issues that Jamie and Emily will be talking about in just a little bit. And of course, the pressing question is: you know, have sites reached capacity? Was were these trends really impacting the site’s ability to participate in new studies? And over 50% of the sites did respond that, in fact, that was the case. In fact, just yesterday, a site told me that they were not entertaining any new sites for the any new studies for the next two or three months. So we are continuing to hear these capacity issues continuing.  

So you know we’ve heard this term, the Great Resignation. It’s been called a number of things: the Great Reshuffle, the Great Quit, the Great Rebalance. But what’s happened since that Great Resignation? We’ve heard a lot of new workforce terms that have been emerging: quiet quitting, and also on the other side of that spectrum, loud quitting. We’ve heard terms such as rusting out, which means you’re kind of staying at your job but becoming less and less engaged. Some information from earlier this year, a Gallup poll was done, looking at engagement and showing only about 32% of U.S. employees are highly engaged in their jobs. So this rusting out phenomenon, where folks just kind of stay hanging on, we’ve heard terms like quiet quitting or quiet firing, coffee badging. This is an interesting one with folks returning to work that they were showing up so that they could badge in, getting a cup of coffee, kind of making that appearance, but then heading home. And amidst all of maybe some of the negative things, there’s also positive. So there’s been this quiet thriving. We’re in this tumultuous environment. We know that sometimes creativity peaks, and some folks get very, very highly engaged in trying to find new ways to tackle the contemporary issues. We’ve also heard about grumpy staying. This, of course, can have a negative impact on the workforce when you have people being vocal about not being happy and the impact it can have on their colleagues, bare minimum Mondays, kind of showing up, but really just showing up and not doing a whole lot, but the bare minimum. Rage applying, this refers to applying to lots and lots of positions at one time, just getting your resume out there and letting people know that you’re looking. There’s also been reference to something called lazy girl jobs. Again, kind of similar to bare minimum, just getting by without having to exert a whole lot of effort, and then career cushioning, applying for jobs or looking while you’re still in your present position. So a bunch of new terms for me, and hopefully that elucidates a little bit about what they mean.  

So I’m going to end my comments with this slide looking at healthcare resignations, and we are using this information from the U.S. Bureau of Labor Statistics to be a proxy for what we’re seeing in research. So as we know, back at the beginning of 2021, that’s when this term, the Great Resignation, was dubbed. It started in 2020, about March, April, when we saw a lot of forced reductions in force, furloughs, early retirements. So those were not voluntary resignations. But then as we entered into early 2021, we saw this mass exodus from the workforce. Some of the estimates were as high as 18 percent, and it started in healthcare as well as technology jobs, but then expanded into others. And as we look at this slide, the blue bars represent the number of U.S. trial starts, and the purple line represents voluntary resignations. So, since that point in early 2021, it’s been a bit erratic, and only recently, in the summer months, and this goes through the end of August, have we really seen the signs of slowing of voluntary resignations. So we’re seeing this as a positive, and with that, some of the anecdotal information that I’ve been hearing from sites that I work with, that their positions are being filled. It still is a challenge, however, that people that are joining these organizations are coming with less experience than perhaps those who vacated those positions. So certainly, site leaders are giving more attention to training to bring people up to that optimal level of making their contributions. But overall, a great sign that the slowing of U.S. voluntary resignations is slowing. With that, I’d like to turn this over to Jamie Harper, Jamie, thanks for joining us today. 

Jamie Harper: 

Thanks, Sandy. I am very encouraged by the downward trend of healthcare resignations, and I’m hopeful that that will also translate to a downward trend in some of the site capacity challenges that we’re currently seeing. But as we know, the site capacity has a different definition based on your role within the clinical research study continuum. An HCO may define site capacity as the number of studies being conducted and available for patients at their institution. A PI may define site capacity the same as an HCO, but with the added caveat of the number of patients enrolled to all the studies being conducted and available. The study team may define site capacity the same as the PI, with the addition of how many visits need to be scheduled, how much data has to be entered, and all of the other aspects of clinical research that have to be conducted for all of the studies being conducted and available at their HCO. As you roll, it gets further into that patient journey. The more granular their capacity definition becomes, and of course, the definition varies from HCO to HCO, PI to PI, and study team to study team.  

So, how we define site capacity in a broad sense? According to Webster, the definition of capacity is the maximum amount that something can contain, or the maximum amount that something or someone can produce. So, let’s look at this a different way. And forgive me if you’ve seen this analogy before, but this jar represents our day as we move through all the responsibilities and tasks required to conduct clinical research. The sand represents all the admin tasks, so for example, ensuring documents are filed in reg binders correctly, or managing email inboxes. These are short tasks that need to get done, important tasks but very granular. The pebbles represent the tasks that allow us to maintain compliance, such as training, maintenance of regulatory documents, and these tasks have a larger impact if the focus is shifted away, the large rocks represent our patients, without whom clinical research does not exist and is our highest priority. So I spoke with a colleague several weeks ago who had attended a clinical research conference recently, and they mentioned that there was a lot of focus on the administrative functions and then also the additional requirements of those administrative functions that were forthcoming, and there was less focus on the research studies themselves and even the patients. So while these administrative tasks may take little time to complete individually, it is very easy to lose count of every grain of sand before realizing our jar is filling up quickly. As study teams continue to activate studies, the amount of compliance and regulatory tasks or pebbles begin to add. As study teams move through training and reg document completion and other tasks that are required to ensure compliance and patient safety, the pebbles continue to fill the jar quickly as sites are not only conducting one study, but five studies, or even 10 studies or more. After focusing on the administrative tasks and compliance and regulatory functions, you can see there is little room in the day to focus on our patients, informing patients about clinical research, informing them about study expectations, answering questions from patients and their families, and just establishing the overall trust that is important for enrollment and retention. This jar, in a nutshell, represents site capacity-how much we can fit into this day with the overarching priorities, while also taking into account the additional challenges in conducting clinical research. One of the biggest challenges that impacts how a study team manages prioritization of their day is staff turnover. In the same conversation with the colleague I had mentioned earlier, they indicated that at some research sites, the highest tenured study team member had 13 months of experience, with the newest tenured team member having only six months of experience, and in a tough study completed in the fall of 2022, they reported that 69% of HCOs had hired a CRC with less than two years of experience. So, Emily, given these numbers, does this resonate with you? Are you surprised? 

Emily Boornazian: 

Thanks, Amy. It really resonated with me when we were reviewing these talking points and some of these numbers, especially the one where you mentioned your colleague had cited that statistic, where most of the most tenured employees on site or site team members only had around 13 months of experience that resonated with me because that is almost exactly what I had experienced when working on site. After about one year into my coordinator position, I ended up being one of the most tenured team members on our study team, and it was really challenging to continuing managing my priorities and managing these studies, while also serving as a resource to some of the newer study team members, whether I was feeling confident to do so or not. So, to answer your question, unfortunately, it does not surprise me.  

So, consequences of the the high turnover that we’re citing here can add to the already overburdened study staff who may have less experience now. Some of these challenges include lack of indication knowledge, EDC and technology portal experience, capacity and priority management, and technology management. The following slides, we’re going to expand on some of these challenges and offer some potential solutions. So, proficient knowledge in the indication being studied is essential to a smooth operation, especially when it comes to reviewing patient charts for eligibility, investigating potential deviations or queries, and entering medical history and medication data. Lack of this knowledge can result in lower data quality, extra communication between clinicians, patients, and sponsors, and can overall contribute to longer study timelines. If you’re leading a less experienced team, consider who are the subject matter experts your team members can rely on. The keyword here is access. If you only have one or two tenured team members, maybe a senior coordinator or level two, who can help train younger and less experienced staff, your team may be challenged with access to key knowledge on the indication itself. So consider the resources available to your institution internally and externally. The obvious start is to rely on your senior team members, but with the high turnover trends we’re discussing, there is a chance your team may not have enough senior members to go to. The clinician team has always served as a great resource for me to shadow and understand diagnosis and treatment processes for the specific indications I worked on. So use your principal and co-investigators and their clinic teams as a resource for insights on diagnosis pathways and different treatment regimens. Even if it’s on the standard of care side, this knowledge can support your team in understanding the indication and how the research protocol you’re working on differs from the standard of care. You can also consider engaging the clinic team in knowledge share sessions or educational sessions to cover specific topics on a regular basis to encourage continuing education. Lastly, consider any external resources available to your team. These can include public webinars, academic journals, or presentations. External resources may also be provided through sponsor vendors, so you can also look through the vendor portfolio provided by your sponsor to see if any can serve your team as subject matter resources. Study training is also an essential part of the study processes for new and experienced coordinators. Each study has their own nuances that differ in many areas. We wanted to focus on three specific areas that pose challenges to study teams when a quick transition occurs or a team member needs coverage.  

Starting off with the EDC portal, each EDC I’ve worked in captures data in very different ways, and there’s always been a little bit of a learning curve when getting introduced to a new portal. Even if it’s the same system, same vendor, each protocol may have completely different data capture setups, so if you have a team member new to the protocol or portal, they may experience more auto or manual queries as they get used to the system. So the next one is the schedule events. I know you’re probably thinking that that’s pretty obvious that the schedule events is going to differ across different protocols, so that is true. But I’m more speaking to the specifics, like visit windows, AESAE criteria, and footnote details that might be easily missed during a quick transition. I worked on oncology studies, and a lot of the protocols showed similar patterns, like the length of the cycles, when scans were to be completed, stuff like that. So oftentimes, it was easier to recognize the similarities across these protocols, and a little bit harder to recognize the differences. If these if these differences aren’t covered during that transition, you may experience more deviation incidents, and lastly, sponsor-specific processes.  

So each sponsor employs different points of contact to support their study sites, including CRAs, CTMs, data management, medical monitors, and so on. It can be challenging when bouncing between studies to remember who should be contacted for what and sharing the actual contact information for the sponsor team. Additionally, some protocols outline specific escalation processes or communication pathways for enrolling patients or reporting SAEs and deviations, and these pathways are something else that can be measured and not covered thoroughly in transition training. So the solution here we’re talking about is cross training. Cross training involves training all of the members on your study team on each active protocol to ensure your team understands the needs of each protocol for an easy transition or coverage. If cross-trained, the team has more flexibility and can leverage their strengths to focus in areas where they excel, while also building new skills. In my experience, being cross-trained gave me more opportunities to work on protocols I wouldn’t have been considered for based on my level of experience, as well. It allowed me to work with more PIs and their clinic teams, and just become more familiar with the overall institution. It also alleviated a lot of the pressures I felt when taking PTO. So just knowing that I would have someone on site that can handle the oversight of the study while I was gone with no major hiccups. We recognize cross training to potentially boost staff retention rates. If site staff members have more opportunities, as I mentioned, I did to work on the more complex trials and expand their skill set. They can use those experiences to leverage promotion and growth opportunities. An increase in growth opportunities, of course, we hope can lead to increased employee retention.  

So, before we continue with more challenges and solutions. We wanted to take a look at the specific responsibilities expected from your study team. This is a job description for a coordinator in 2023. Pulled from Indeed.com. I bolded the action verbs in this job description, and as you can see, it can be a little overwhelming, especially for individuals who only have the credentials outlined on the right side of the screen, while I was looking for the job description, I looked at about five to six CRC job postings, and each post each position required something closely to needing an associate’s or bachelor’s degree, one to three years of experience, and some level of healthcare knowledge. The job description includes a lot of heavy duties, like managing, directing, being a liaison, and being responsible for regulatory compliance, budgets, and laboratory activities. This is a lot for someone with only one to three years of experience, and like we cited earlier even less than six months of experience for most study team members, and this comparison we hope to demonstrate the importance to consider how much support your study team really needs in order to perform each task to the best of their ability. This slide here is meant to visualize the job description we just reviewed. You can see the different tasks grouped into study startup, recruitment, patient retention, data management, and regulatory activities. We wanted to further demonstrate here how those tasks multiply across multiple studies that one coordinator may be responsible for. We found when reviewing turnover data that one of the top reasons for CRC job dissatisfaction is the workload itself.  

So the next couple of slides, we’re going to cover a potential solution and tool to support your study team and alleviate the high workload burden. So, task distribution is a possible solution that can lessen the burden on primary coordinators. In my experience as a site coordinator and working with sites through WCG, I recognize more sites structuring their teams with multiple roles that are responsible for certain areas within the umbrella of CRC responsibilities. This may include data managers to handle data entry resolution, startup coordinators to manage study startup activities, regulatory specialists focusing on maintenance and startup of regulatory, and recruitment specialists handling outreach on potential patients. This structure is not meant to replace a primary CRC. We would still expect a primary CRC to lead the overall conduct of the study. Rather, it’s meant to support the primary CRC and allow them to focus on patient enrollment and retention and other high priority tasks that need to be completed in real time. The structure may also alleviate any bottlenecks that occur when the primary CRC is not able to get to some of the back end or administrative tasks. We also feel that this structure opens up opportunities for sites to seek talent that appeal to the more specific tasks, broadening talent pools and engaging more high potential individuals to your team. This goes hand in hand with the process of cross training as well, where having more staff members involved in a protocol can cushion turnover for smoother coverage or transition. There’s also the component of staffing retention by opening more opportunities for team members to build new skills, leading to growth and/or promotion.  

Lastly, this structure also presents opportunities for your team members to become subject matter experts in their specific areas and serve as resources to other team members. So, task distribution still doesn’t address the challenge primary coordinators face with prioritizing their responsibilities across multiple studies. This is a priority funnel that a mentor of mine provided to me during my first few weeks as a coordinator, and it served as the foundation on how I would structure my days. On site, you would often hear the term “putting out fires, and the challenge is when you’re presented 10 fires, which one do you get to first? Or when you finally have a moment to get to your desk, what administrative task are you going to address first in case you get pulled in another direction? Applying this priority structure streamlines our decision making as primary coordinators and allowed our department to manage our time more efficiently and effectively. For me, it certainly calmed the overwhelming feeling when having so much to do by providing a basis on how my decisions were made, and and those decisions can be recognized and understood by the rest of my team. So this funnel here on the screen worked well for me at the site I worked at and the types of protocols I work on. However, this exact structure may need to be amended to fit your processes and studies. If you are a site coordinator or a site leader, I encourage you to think what tasks often pop up for your primary coordinators, and how would you want them to prioritize those tasks? Or consider what bottlenecks are forming and target those tasks to be at the top of the funnel to alleviate any backlogs from forming.  

The last challenge we’re discussing today aligns closely with some of the other solutions we have already discussed. We recognize with every protocol there is a handful of portals the study team needs access to to conduct essential study activities. This might include the EDC, CTMS, diary portal, pharmacy dispensing portal, the binders for source documents, regulatory binders, and the site’s AMR. This list is certainly not all-encompassing, and we know that studies vary in the technology components that are attached to them. The challenge is maintaining each portal. We wanted to call out here, as you can see, there’s a star next to the e-diary portal that the technology components not only affect the study team but also the participants, as they are now often required to participate in data collection through apps and tablets from home. We know these decentralized components of the study are aimed to streamline data collection and make participation more accessible. However, it is important to recognize the additional burdens the site team may take on to manage these portals and support their patients in any troubleshooting needed. This challenge occurs at the crossroad between technology and people, and the solutions discussed earlier, can be applied to alleviate these burdens. Cross-training on each portal and task distribution will give more flexibility for coverage and transition for your site team members. Consider where each portal will fall within the priority funnel, and which team members can be responsible for maintaining the portal. Additionally, consider who you can rely on for patient support through your subject matter experts that are comfortable in each portal and are able to troubleshoot with patients. Whether this is an internal resource or if there are sponsor-provided resources that can help serve your team and patients. So with that, I’m going to hand it back over to Jamie for some final thoughts before we get into some questions and answers. 

Jamie Harper: 

Thanks, Emily. This has been great information, and something you mentioned really resonates with me, and that was the priority funnel. So I think that’s a great way to use that tool to be able to put together everything that we’ve talked about today and rearrange our clinical research jar just a little bit. So let’s take everything out and we’ll start over based on that priority fund concept. So by rearranging our focus to patients first, new and current, you can see we have more opportunity to focus on building that rapport and trust with patients who are in normal clinical trials. Whether it’s answering questions about scheduling treatments or symptoms, we can ensure patients are well informed and more likely to have positive clinical trial experience.  

So, moving down the priority funnel, we can continue to add our pebbles: the compliance and regulatory tasks, such as the SAE reporting, the CTMS reporting, ordering data entry that were mentioned earlier. These tasks can easily fill the space in between patient activities, and I know what you’re thinking: the jar is full. There’s no possible way we could add in all of the admin tasks we have to begin. And while those tasks are many, they can be completed in a relatively short amount of time and fill in all the gaps where we’re not focused on patients or completing compliance and regulatory transitions. So hopefully, the takeaway from this webinar is that capacity holds a different definition for every HCO and every person involved in clinical research. Identifying creative solutions to addressing capacity constraints, such as the ones we’ve discussed today allows us to build a toolbox full of new ideas that can be drawn upon as we continue to move through the evolving clinical research landscape. So we hope you enjoyed the webinar today, and we thank you for taking time out of your business schedules to attend and view our session. At this time, we’re happy to answer any questions from the audience. 

Sandy Smith: 

Jamie and Emily, thank you so very much for the really thoughtful presentation. There’s lots of heart emojis and thumbs up and clapping that’s coming into the Q and A. So obviously, your comments resonated quite well with our viewers today. So, a couple of questions for you to respond to. The first is: someone said they’re a bit curious about the uptake from sites on the use of remote clinical coordinator support and how it’s being funded. Could you speak to that, please? 

Jamie Harper: 

That’s a great question, and I think it’s a different answer pre-pandemic versus post-pandemic. Pre-pandemic, we were very much on-site. There were still a lot of sites that had paper charts. The pandemic has allowed us to transition more into that remote support and set us a very loosely for eReg binders for offering remote access to EMRs. So we have been able to see an uptick in remote support at our clinical research sites, even more so than we have in the past. Emily, can you speak to some of the conversations you’ve had with some sites? 

Emily Boornazian: 

Yeah. So when when we start engaging with the site, we often talk about how can we support their team members remotely. You know, through our services. A lot of those include data entry, managing those binders, even the recruitment side of things, a lot of that can be done remotely, and I’ve gotten some really great feedback from sites on when they use our services in that in that way, where we’re remote and on site. It allows their site team to really free up time to focus on those hyper tasks, managing the current patients and getting them enrolled. 

Sandy Smith: 

You know, it’s interesting. I think sites have been quite creative and thoughtful about how they may be able to reorganize work. I was speaking with the cancer center recently, and they were talking about the schedule for infusion room nurses and how you would think that infusion room nurses have to be there, you know, five days a week. But what they were able to do was reorganize the work and all of the administrative tasks. Have that be performed by a person remotely. So the schedule now for the full-time nurses is four days on site, one day remote. So again, I think continuing to be open to new solutions, new approaches, new partnerships, and just new ways of doing things in general. People are coming up with really interesting approaches. Another question: How can sites better manage their own site capacity issues? 

Speaker 1 

So you’ve kind of addressed some of it, but maybe just to restate some of the highlights appreciate this one. We covered a few different things, but I think for me on site, just acknowledging that we were having challenges with capacity, that priority funnel I talked about really served as a tool that I, you know, constantly rely on and refer to in managing my days. Jamie kind of alluded to only having you only have so much time in the day. Your your dark moment gets so full. So really focusing on how you can support your team so that they know what to get to first and how to really fill their day so that they can be as efficient as possible. 

Emily Boornazian: 

And I do think there are also things that sponsors and CROs can do to help sites address their capacity issues. Really looking at the protocol itself and doing a 360 review of the protocol, and really assessing the wants versus the needs and requirements of, say, IE criteria or tests and procedures in the schedule of events, and making sure that what they’re asking the site to conduct is truly necessary for the purpose of that clinical research protocol and the end goals for that for that particular indication, so there are things that sponsor CROs can do as well to help with that capacity challenge. 

Sandy Smith: 

So, a couple questions specific to your presentation. One is, can you explain CTMS duty in a little more detail? 

Emily Boornazian: 

Yeah, I can cover that one. So CTMS is short for Clinical Trial Management System. This was a tool that we used on site that held all of the protocol calendars. It’s where we organized our research subjects, where we, you know, would log if certain visits occurred. What occurred during those visits, and it was also tied, you know, to the back end of the finance pieces of clinical research. So, just carving out time to make sure we were tracking our patients correctly and certifying those visits. That’s really what what you know the the actual task is that I was focusing on on site. 

Jamie Harper: 

Thanks. And then, yep. But the other aspect to that is that we have the the clinical research coordinator side, the end user. But then there also has to be somebody upstream who’s entering all of that information into the CTMS itself, who’s building out that calendar for the protocol, who’s entering in all of the financials based on their master’s charge, their charge master, and the finalized CTA. So there’s a lot of input that has to go into that CTMS reporting for it to function accordingly. So it is it is very time consuming. 

Sandy Smith: 

So a comment and a question. Rodney shares with us a great use of Stephen Covey’s first things first jar. I encourage others to read his book as I still see staff having trouble understanding what to do, and the other resource is urgent versus important matrix. So Rodney, thanks for sharing that, and then related to the jar analogy, we have a question that says: As the jar is reorganized, what’s the best way to do to organize the day-to-day work for a novice coordinator who is a linear learner? 

Jamie Harper: 

Great question. I do think it goes back to that priority funnel of focusing on patients first, and making sure that the patients are taken care of, their needs are addressed, their questions are answered in a compliant and in a compliant way, and I think it’s all going to tie together. But focusing on those patients first, everything else is going to fall into place after that. 

Emily Boornazian: 

Yeah, and I can add something here too. When we reference, you know, who are your subject matter experts, whoever they are, they can also be a resource in bringing your novice coordinator up to speed with, you know how to deal with patients, how to get them scheduled. However, you know it works at your institution, but really relying on those subject matter experts to train the new you know new coordinator at site. I also know just from experience, I think a lot of people learn by doing. So really allowing them to have the opportunity to work on different studies, get trained on different studies, and you know get exposure to that with you know appropriate people who can be there to train them and oversee them as they’re they’re getting on board. 

Sandy Smith: 

Erena asks a question: Are other sites experiencing administrative task fatigue? 

Jamie Harper: 

I think that’s a common theme, and it can be just as simple as the number of emails you get in your inbox. In your, you become overwhelmed by just where do I even go within my inbox, how do I prioritize my emails? Much less, how do I prioritize the scheduling of patients and then talking to the patients? It is it is a lot of again little tasks that don’t take a lot of time, but they are like very cool for me. 

Sandy Smith: 

And you know, Jamie, you made a point earlier about technology, and I think as we have research-specific technology to keep many of the tasks that are part of the day-to-day work within that research technology, and not having to go look through perhaps hundreds of emails that folks are getting a day to find that one important one that’s needed to make a decision on you know a patient next step in a clinical trial or whatever. So finding those things that support workflows specific to research and not being mired down by wading through the emails and possibly overlooking that one that is critically important. We also had a question about what should employers do to guarantee employee satisfaction and improve retention? You know, this one’s a tough one. Anytime I see guarantee, I’m reminded of we’re dealing with humans, and there are probably no guarantees. But in a lot of my work in following issues that have contributed to the Great resignation and issues affecting the work workforce today. I’ve seen that a lot of it has to do with being present, listening, conducting employee satisfaction surveys, doing things that build and bond teams together. But I’m interested if if Jamie, you, or Emily have anything more to contribute to a response to this question? 

Emily Boornazian: 

I can I can start, Jamie, and then hand it off to you if you have any other thoughts. But one thing that I think it’s important for an employer to consider is what motivates their team, the people that they’re bringing on board. What are their motivating factors to want to stay, and I think for a lot of people in the research world, in academia, growth and you know learning new skills, learning is definitely something that motivates a lot of people. So, just constantly providing those opportunities to your team members, no matter where they fall, you know, on their experience level, and just making sure that that educational factor is there and that growth factor is there, I believe that that can really add to the retention of your employees and motivate them to stay within your team and work on these studies. 

Jamie Harper: 

I think in addition to that, and those are great points, Emily, is maintaining that open line of communication as far as I acknowledge that you are doing so much. Here’s what I’m trying to do to help you, and then on top of that, offering grace, just realizing that everyone’s under a lot of pressure and mistakes are going to happen, and if they do offer that grace and that training to help them through it, we’re all in this together. 

Sandy Smith: 

Great points. So we have a question on clinician engagement and whether you have any tips on clinician engagement. Knowing both of you worked at at sites where you interacted with physicians all the time, what do you have to share? 

Emily Boornazian: 

For me, I would just hang out in the clinic. You know, I would find a computer and stay put. And you know, usually I would have a question to ask someone, but I really would try to, if I had time to do administrative tests, I would do it, you know, in the clinic and try to hear the lingo, hear what they’re doing, make sure I was getting to know everyone so that they could also serve as a subject matter resource for me, and really developing that relationship with the clinic team. I think is important since you know they’re busy with our days, so yeah, I think really just being present for them to to help you out would be my first thought that that came to mind. 

Jamie Harper: 

And I think that’s a great point. And as you’re present and as you’re hanging out in the clinic, you’re gonna get to realize and understand their preferences. So instead of us trying to get with the PI and communicate the way we feel would be appropriate, understanding PI, what is the most appropriate way to communicate to you? How would you prefer I do this? What’s going to be easiest for you in understanding their preferences? That will go a long way. 

Sandy Smith: 

You know, I worked with a site that the physicians were highly engaged in research, partially because it was a culture of research. But one physician who did a lot of phase one work said, “My coordinators make it easier for me to enroll a patient on a clinical trial than to prescribe standard of care. That’s easily said in these days of staffing shortages, but where we can have everybody work to the top of their license, if it’s a licensed professional, or to the top of their job description, I think that physicians are pulled in many directions as well, and time challenged, and we certainly want to give every potential participant or patient the opportunity to enroll in a clinical trial. So we’ll take a couple more questions. One relates back to your comments earlier on relying on SMEs. Do you have ideas on how to best ensure this is recognized? Are you seeing an increase in pay, for example, and their comment is they find the experienced staff have more studies, and it’s hard to carve out time. So they’re just open to any ideas that you have. 

Emily Boornazian: 

Yeah, I can I can jump in here. Sorry, Jamie, I cut you off. But yeah, I think it is a hard one to address. You know, when people do get that more experience and more of that subject matter expertise, they are relied on a lot more. And I think that’s where we kind of point out that that is something that these SMEs can leverage for growth and promotion opportunities. You know, a lot of that is dependent on on the site and their employer, but that is something that you know we we feel that we wanted to call out today. 

Jamie Harper: 

And I think it’s getting creative and how to collaborate with those SMEs. So it may not be a matter of carving out time. It may not be a matter of scheduling a two-hour meeting to have a conversation. It may be, can I shadow you for half an hour? Let me see how you do this, so that way it’s not interrupting their day, but they’re teaching, but also getting their tasks done and the more less tenured researcher is also gaining that experience at the same time. So being creative and how that communication goes back and forth. 

Sandy Smith: 

Fantastic. Well, Emily and Jamie, thank you so much for sharing your experience of some different approaches to consider on addressing workforce capacity issues. We want to thank all of you for joining us today. And with that, mentioning that there are lots of educational opportunities available on the WCG website. And Emily mentioned this during her presentation. First and foremost, a free CenterWatch subscription every Monday morning. I have kind of an update on what’s going on. New regulatory changes are always highlighted through CenterWatch, and we do have the web address there. If you’re bringing in new staff and you need electronic tools to help with training, there are CRC, CRA, and PI training modules and guides available through Center Watch, which is a part of WCG.  

Also, more formally, we have our MAGI conference. We were pleased at offering a virtual version just recently with 1000 plus attendees. We will be back in person in the spring in New Orleans. So, if you’re interested in attending or speaking at Magi, you can reach out to us. For those of you interested in tools that may help you with your quality management, I’ll mention the Avoca Group, which again is a part of WCG, has an Avoca Quality Consortium with a knowledge center with over 1000 different tools and templates that are pre-developed to help you with a variety of things, including how to prepare for an FDA audit, and we have a number of other webinars that are all archived, podcasts, blogs, white papers, any of the contemporary issues that are going on in clinical research or related to new FDA mandates or guidance, you will find resources on our website at www.wcgclinical.com.  

And lastly, we all do this as a focus on advancing science and for patients and participants, and with that, WCG also has a focus on patients. And annually, do have a WCG patient forum, which we just offered in October. That is also archived. Just great inspiration, and it’s in smaller segments. It’s overall a three-hour program, but smaller segments. If you just need a little uplift or maybe a experience to put in front of your team at a at a staff meeting, I think it’s just a nice reminder of why we get up every day and show up for work. As I mentioned previously, we will be updating our 2023 survey in 2024, so we’re all eager to see how that reduction in U.S. healthcare resignation translates into clinical research and the challenges that sites will be facing in 2024. So look for that survey. We’ll be eager for your responses as well as any of the other solutions available from WCG, which you can find on our website, and lastly, reminding you that our 2024 trends report will be out in January, so be on the lookout for that.  

We thank you for your time joining us today. We know that not only in your busy day-to-day functions as research professionals, but as we wind down this year, taking any time away is critically important. So thank you for giving us your time, and hopefully you have some great takeaways from today’s session. Wishing you all health and happiness in the new year. Thanks again for joining.