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Parexel FSPs, Lisa Feeney, Vice President, FSP Operations, is joined by Jennifer Sheller, North America Regional Head, Global Clinical Trial Operations at Merck, to discuss how to prepare the CRA workforce of the future. They also discuss how the CRA role has changed, the demands CRAs face today, and strategies to recruit and develop CRAs to meet tomorrow’s competency requirements.
00:00:10:10 [Katherine Cloninger]: Good morning. Good afternoon. And good evening to our global viewers. I'm Katherine Cloninger director of clinical research marketing at Parexel and delighted to welcome all of you to our first webinar in our workforce of the future series. Today, we're talking about CRA's and we'll touch on recruitment, professional development and retention strategies. Both speakers have dedicated their careers to clinical research. Jennifer Sheller joins us for Merck where she's the North American head of clinical operations. Lisa Feeney is the Vice President of FSP operations at Parexel FSP. Today's discussion is intended to be informal. There are no slides, and we have plenty of time for questions. So please use the Q and A button at the bottom of your screen to ask away. There's a lot to talk about. So, I'll hand the mic over to Lisa Feeney to get the conversation started.
00:01:07:25 [Lisa Feeney]: Thank you, Kat. So clinical research has transformed over the last 10 years, and so as the talent needed to support successful clinical trials, the demands of a typical CRA have rapidly evolved. But job competencies haven't kept pace with the converging trend of more data, digital technologies, complex procedures novel therapies, recruitment, and retention. Certainly, for more niche populations and new methodologies for study conduct. So, responsibilities that once focused on paper-based tasks, like documentation compliance, drug accountability, source data verification now focus more on data analytics, across many, many data sources risk management and the management of more complex trials. Jen and I certainly both of us recall the, the STV and everything being done in three-part NCR for case report form. So certainly, things have come a long way. There's a shortage of skills and critical thinking needed for trials of today and tomorrow.
00:02:21:02 [Lisa Feeney]: And that's been intensified by gap in talent development. So experienced CRA's are retiring or changing roles progressing in their career. And so, it's leaving an experience gap for sponsors and CRO’s to try and fill. As roles change, competency requirements also change, and this has a significant impact on productivity job satisfaction, performance, and certainly retention. So today Jen and I will be discussing the evolving CRA role, how it's changed and how we can address the need for new skills, with training and talent to fix the gaps while we prepare today's workforce for the skills we envision needing in the future. So, Jen, let me first ask in your experience, how has the role of the CRA changed over the last several years?
00:03:14:29 [Jennifer Sheller]: Hi, Lisa, it's great to be with you today. I look forward to this discussion and you know, as you highlight, gone are the days of the three-part NCR paper CRS. I remember being very proud when we could fill a truck full of paper that was on its way down to the FDA for a filing. And certainly, technology has taken over in much that we do, and doesn't always simplify things. So, to your point with the evolution of clinical trial design and operational strategies, this has a significant impact on the role of the CRA and it continues to evolve. If all those trials become more complex you know, with increase of technology and as well as a lot more data collection when you look at trials today, they have several vendors, maybe nine or 10 vendors per trial on average.
00:04:06:23 [Jennifer Sheller]: This is much different than what we've had in years past and CRA’s are managing not just one trial or one therapeutic area. Although we do try to keep some series more focused on oncology there, CRA’s are managing multiple trials. So that's 10 vendors per trial, multiple trials that's a lot to become familiar with and maintain. And then this is coupled with a series, really our frontline with our clinical research sites who also are often part of large institutions and use many different systems across the board, even within a country. You know, you look at source documents, not all sites use EMR today. And those that do there's many different types of EMR to navigate and become familiar with. And this has become even more attuned as we're in the world of remote monitoring and in the COVID environment. So, there's a lot of variety within studies at the sponsor level and CRO, but also within our sites, even within a single site, but also across sites within different areas. So, it's a lot for surveys to really digest and interpret and then apply GCP and trial compliance principles as they navigate these complexities. You know, the role has also evolved. Fortunately, we have more focus on risk-based approaches, which is great, really trying to focus more on critical data and what's important. This also comes with additional tools and roles across clinical trial teams to help identify signal detection. And you have to really kind of weigh that with what's noise versus true detection, and really become comfortable with a focus on critical data versus what we did historically is looking at everything a hundred percent from A to Z.
00:05:52:27 [Jennifer Sheller]: So, I think as you highlighted earlier, the CRA role and the skill to be able to interpret data leverage many different types of technology systems and really work with more analytics in monitoring activities and not just the head down approach of comparing documents. This is really, I would say a major part of the evolution of CRA's and when they're managing sites, they need to be looking at trends and are you seeing minor deviations trend where you need to have a stronger action plan with a site and we're in the realm of using things like scorecards, so we can share with sites how their performance is on a given trial. So, we have more data-driven discussions, but for the CRA this means they really have to pivot. They have to go from the big picture, down into the weeds to do some of the more detailed checks. So, it's quite different from when you and I started and continues to involve with these complexities.
00:06:54:00 [Lisa Feeney]: Thanks. Thanks, Jen. I think back to a few things that you said, I remember working on regulatory and loading those big trucks going down to the FDA. So certainly, things have changed since that time. So certainly, data analytics, right? I mean and what the CRA's have access to these days for data is certainly really helpful and something I think we all wish that we had years ago, but it's helpful. It's helpful for them and in guiding their sites and knowing where to put their focus. So, Jen, how can we as an industry develop and continually reinforce these new skills that are needed, like what efforts are currently in place and then how do we address the gaps?
00:07:38:25 [Jennifer Sheller]: Yeah. And when you look at clinical trials, it's an exciting time today. And they continue to rise there's more and more trials, but we haven't kept up with the resources and talent development. So, for me, the crux of the focus needs to start collectively as an industry to do a better job. And we're dedicated job in growing our workforce. We have to grow our workforce to keep up with the demands and then also to build in the training for these skills and data analytic components as we highlighted. And now it's now the opportunity time with COVID clinical trials are in the public spotlight and people know what they are. They're excited about them. They're excited even to participate them and it's in the dialogue. So, I think now more than ever as a great time for all of us across the industry to tap into this public curiosity and there's lots that we can do individually and collectively to take it out there and raise awareness, not only about clinical trials, but about the career paths and clinical trials you know, talking to students, they don't even realize this was an option. There's so many traditional trajectories that this one is missed, and this is a fantastic career as we can attest to doing clinical operations for over 20 years and still loving it. And you know, when you look at the talent gap, it's not just limited to CRA’s, of course it also affects other key functions, running clinical trials, like our study managers and clinical scientists and other roles. But I think we do need to remember that the CRA role is really often a feeder pool, right? For other clinical roles, we need to look at some of our senior leadership including at Merck they started as a CRA, which is pretty inspiring, I think to CRA's and those coming into the field out there it's really gives us a core foundation and an understanding of our most precious collaboration, which is that with our sites. Our CRA’s I think understand best the challenges and nuances that our sites face.
00:09:43:14 [Jennifer Sheller]: So, when we're looking at addressing the gaps, I think we really need to look at growing the workforce and walking the talk and not always mandating a senior person for our roles and also looking at the ways we recruit and looking to diversify the sources of resources that we tap into. There's lots of efforts underway at both of our organizations with diversity and inclusion. And you know, that the time to do that as also with not only developing our talent, but recruiting new talent and looking at different sources where we can get more diverse workforce at Merck, I can say that we have expanded our intern program. So, we are hiring college grads who don't have any experience in clinical research, other than coming in for an internship. And even we're going beyond that because it's working so well in the US internships are very short. Typically, three months, doesn't give you a whole lot. So, we've adapted actually our job description and, and Lisa, you know, this well too, because we apply it to our partners. And in that we do allow talent to come in that doesn't have direct experience. We have to get out of that catch 22 of you must have one to two years of industry experience and really build it you know, with robust onboarding hands-on experience mentorship, we have such incredible experienced seasoned talent out there who are often very willing to be mentors. And it's a great marriage of the two needs. I also just want to highlight we are a part of the ACRP partnership and workforce advancement, which is also committed to growing, diversifying and standardizing some of the workforce competencies. And we have built this into our entry-level training with the professional certification and training, and really getting those simulation modules so they can have hands-on experience coupled with the mentorship and getting out there and really doing the work.
00:11:48:22 [Lisa Feeney]: Thanks, Jen. Yeah. I could not agree with you more. I mean, a lot of us and to many of us that senior leadership, as you mentioned, have experienced being CRA's because it is a complex position with a lot of responsibility and the fact that they understand that and have lived that I think certainly helps all of us. I agree with you wholeheartedly on what you said about building the workforce, right. We all have an obligation in industry to assist in this. So how at Merck do you successfully recruit CRA's?
00:12:23:07 [Jennifer Sheller]: Yeah, and we follow the traditional methods that probably a lot of organizations do. I think referrals are the best try and a CRA referring, or somebody referring a CRA is one of the greatest testaments of quality because people aren't going to put themselves out there without referring someone who's really strong. We also use ACRP, they have a great career center. And you know, we've been working on our university partnerships and making sure we're getting out there. We have our first career fair next week, and we're going to be doing some road shows just to share a day in the life of different roles, like the CRA medical writers, study manager and engaging alumni, and really working to ensure we have a diverse geography and footprint. I think the beauty of our clinical research roles, including the CRA is that they're remote so we can go anywhere in the country, which allows us to really better diversify. And the one thing that I wanted to mention as well. When I shared that we should all ensure that we have entry-level positions, but we also should think of ourselves in this profession as community ambassadors getting out there and sharing you know, within our communities, what is clinical research and one thing that we're doing at Merck, and we did some of this work with executive families says really getting out to students and sharing what is clinical research and what is a CRA so that even high school students or college students, as they're thinking about their journeys, just to know that this is out there and it's a very rewarding profession in and of itself, I think many of us stumbled upon it by accident taking some traditional trajectories and the pre-med and different scientific or clinical routes, but to get out there and share that this exists, I think just goes a tremendous way. And we've reached in our first two years or so, we've reached over a thousand students across the US with just our Merck team using their volunteer hours to share this. And some of the impacts have been quite remarkable. And in talking to the college students, they're saying I'm going to change my major. You know, this is really exciting. I want to really get myself prepared to be able to become a CRA one day and potentially the other aspects of clinical research. So really getting out there and sharing with schools, you'd be surprised at how interested even STEM programs in high schools and by advanced biology I've been out there myself and it's rewarding, and this is grassroots what we're doing, but if we all collectively invested some efforts there, it's really minimal investment to help educate and raise awareness. And that will bring us a longer-term strategy or investment of potential candidates down the line.
00:15:21:24 [Lisa Feeney]: Yeah. Thank you, Jen. I couldn't agree with you more. I mean, I feel I decided I look back to when I decided to get into clinical research, and I was in college and decided that that's the career path I wanted to take. And someone took the chance on me, right? I had no clinical research experience clearly. So, the fact that somebody took a chance on me and brought me in. I'm forever thankful, and we're finding that in the people that we're bringing in, I have no clinical research experience. They're eager, they're hungry, they're invested. And that's valuable. That's the type of people we want, right. That we want to bring into this. I actually have three sons in college. And one of their universities I'm already speaking with, I'm going to go to the university and speak with their college students about careers and job opportunities and clinical research. Heck I should go to all three of their universities. I'll do a country tour. So it's exciting. And that's one avenue, right? To build the workforce. Another avenue we're finding, and we've found in the past is bringing people in that are within pharma, but they want to expand their horizons and get into clinical. And we found a lot of people in the labs in the past you know, they develop a compound and then they want to see what happens after that. So, sort of their interest and curiosity gets the best of them. And they want to know you know, where it's going to go from there. So, I'm passionate about this field as a profession, I've spent my entire professional career here, as I believe you have as well. So, I hope that others that we bring in feel the same way. So, Jen, what drove Merck to rethink talent development and training?
00:17:13:14 [Jennifer Sheller]: Yeah. And as you know, over the course of the last few years, Merck has moved to in-source model with FSP and you know, have sort of grown the operational workforce. And as we've evolved you know, we invested heavily in an internship program. and as that was kicked off, you know with Merck research laboratories, there was over 400 interns as an example. A few years ago we had a very interested early talent in clinical research, but we didn't have a position for them because we had that catch 22 of you have one or two years of specific experience. So, we thought, well, this is really kind of a waste. So, we changed our job description and built a program an early talent program it's led by Michelle Mitri that really has specific training courses, but also those hands-on experiences. And they built a comprehensive list of experiences that this early talent needs to get their hands on. And then they're super quick to contribute as you know, Lisa. I mean, as you said, somebody took a chance on you and you know, when you do that and people are hungry, the rewards are tremendous. And you know, like I said earlier, we have the seasoned workforce who are actually very interested in mentoring and training. So, it’s just such a great combination together. So, we continue to grow it. You know, we started with our interns, we did an intern to hire program. We're now expanding beyond interns and going out more to universities. And to your point also record recruiting study coordinators or others who want to join the industry. And you know, we've certainly seen the scientists transition from the lab as well. And that can be a great success too.
00:19:08:18 [Lisa Feeney]: Thanks, Jen. What about, has this training investment impacted retention?
00:19:15:05 [Jennifer Sheller]: Yeah, I mean, it's early cause we've been doing this just a few years. So far everybody's with us. And we do have great retention overall. We do invest a lot in Merck has tremendous support, but also, we invest a lot in our talent and our first cohorts intern to hire from 2018. I think they started in 2019, but were recruited in 2018. They've moved on to graduate to their next roles within clinical research. And they've taken different pathways, which I think is important that we're all flexible to support that as well, especially when you have long tenures you know, in this profession, it's nice to sort of spiderweb and get different experiences across. but so far everybody's with us. And I think as you mentioned earlier, it's just when you invest in someone, you get that much back, and people become quite loyal to the mission and the model because they see how much you value them as people. People are what it's all about.
00:20:19:26 [Lisa Feeney]: Exactly. Jen, that's what we're finding as well, but they, they really appreciate that. We took a chance on them, right. It's such as I appreciate that somebody took a chance on me, then I stayed with that organization for 18 years. So, there is that loyalty. So, what other significant considerations are there for retention? I know the CRA specifically the CRA role is a very it's a very intense role, so possibly to either offset stress or burnout.
00:20:49:27 [Jennifer Sheller]: Yeah. And I remember the earlier days when we weren't regionalized you know, leaving from Philadelphia to somewhere in the Midwest and waking up, just thinking, where am I today? What time zone am I on? It was you know, four days a week and getting back to do your trip reports. And unfortunately, the industry has shifted to a better model. Less travel I think is important to have that balance, especially. So, you know, our CRA’s can be home with their families and finding that good balance. So, when the regionalization has been a key, the other is some people are joining clinical research because they have a passion, maybe they've had an experience or they themselves have been a patient and they want to really contribute to oncology research or pediatrics. So certainly, we can meet the needs of those passions, right. And couple CRA’s with assignments in those therapeutic areas. I also think we need to really recognize CRA's they are frontlines. They are one of the most critical roles in clinical research and that really needs to be recognized. And you know, we have different programs as you do for recognition, whether it's a thank you and a note or a gift card and some sort of point system or what have you. But I think it's important that we take the time to really recognize the contributions of CRA's and really making others aware in clinical research, what a CRA does. You know, I think one thing that we've found in high value is taking different leaders out with the CRA to see what it's like to have to navigate a site and work with the site and have all that external management and matrix to really get what we need for our clinical trial.
00:22:36:22 [Jennifer Sheller]: It's a lot, and it's very eye opening when you get some guests to join you out there. The other piece, we hear a lot from our CRA's, as we're evolving operations and developing new processes, make sure you include the CRA in that, because they can really give you some of the best insights on how it's going to work day to day and with our sites in particular too. And we're always looking at what the role of the CRA is. It's quite varied across companies as far as what CRA’s are doing today, but there's always opportunity, I think, to make sure that we're taking as much as we can administratively off their workload so they can spend time, you know managing their sites and managing important GCP issues. I think of things like training records and making sure systems are updated. That's something that we continue to see work on to try to improve for our CRA’s. So, they don't lose hours to those types of things.
00:23:35:16 [Lisa Feeney]: Yeah. I think that's a smart move. CRA's who monitor want to monitor, so yeah, that's what we continually hear. So, I think, yeah, that's very smart. So, beyond the initial training, what does an effective mentorship program look like?
00:23:52:12 [Jennifer Sheller]: Yeah, and I think when you have a mentorship program, make sure you're giving those mentors time to do it. I think the worst you can have is somebody coming in and feeling like they're bothering their mentor because they're just so overwhelmed. So, I think that's one of the first and most important points. I still remember my first mentors coming in and I remember always asking questions and thinking, oh my gosh, they're gonna they're gonna kill me. I keep asking. I keep bothering them. But patience and availability is such an important thing for mentors. So, you have to free them up a little for their workloads so that they can do it. The other component too, I think is I learned a lot early on and with coal monitoring and getting out there with actually my manager when I was first working as a CRA many years ago, and I think that's a great way to learn from a seasoned CRA, right.
00:24:45:14 [Jennifer Sheller]: And also do the work directly. We also have a lot of subject matter expert roles in different topics. And our goal is that they are available for questions. So, making sure our entry level folks know who they are so they can tap into and ask questions. You got to ask a lot of questions when you're coming in. It's a lot of work. But if you have the right experts out there and seasoned talent, it works beautifully. And you know, the entry-level staff that we have coming in or career changes, or what have you while they're learning this and developing their CRA expertise it's also important to invite them into other projects that are helping supporting operations more broadly and you know, improving clinical research. We've had some great experience in bringing in talent to drive things that are unrelated to the CRA work, but very operational and sort of helping them see the bigger picture of how the clinical trial engine is working. And it's great to have them a part of it because they have fresh perspective, new ideas and not sitting maybe in a headquarter seat, or they're not. So, exposed to the day-to-day of what our customers are facing and our customers, our sites and our patients.
00:26:06:16 [Lisa Feeney]: Thanks, Jen. I do recall my mentor very well and it made a huge difference in my career and my position as a CRA to have somebody who was passionate and wanted to teach and took all of my million questions. Right. But was always there for me without passing judgment on my questions. And I still remember that person very fondly today. So, as you stated, they made they had a huge impact on our CRA position, but then also on our career, I kept in touch with that person for years. So certainly, very influential, but I feel it has to be somebody who wants to do that. Right. And has the time to do that exactly. As you stated, I feel that's important to set both parties up for success. Yeah. So, Jen, what do you expect the CRA job expectations to look like say in the next three to five years from now, and also what impact has COVID had on that.
00:27:10:16 [Jennifer Sheller]: Yeah. And when I think of the role of this year, I won't change. CRA’s will continue to need to be relationship builders with our sites. They’re our front lines and I think the first CRA’s out there was the Salesforce. Right. And having been in that relationship building and negotiation, and that's not going to go away and will become ever more important, especially as we're working virtually like in the Covid environment. In talking with sites, I think we're going to continue on with a lot of remote source work and other activities coupled with that onsite time. So, we have to support our CRA's and having those virtual conversations, but also teaching some of the soft skills and even recognizing the sites for our work, just being there to support them and communicating that and not always just reaching out when something is needed because you know, those relationships really build the trust. And sites want to trust CRA’s who have the expertise. So, we have to make sure our CRA’s are constantly refreshed with ICH GCP. And even if you go through training and get a graduate degree, it's always good to refresh on GCP principles and real-world application. I think all of us you know, should continue to refresh that and invest in our CRA's to do so. And the role is vast of the CRA, as we said earlier, navigating so many different technologies and systems, and that will continue to be on the rise. Maybe we'll see more you know, direct data feeds and the risk-based approach and focus and site management is gonna you know, be probably a greater focus. And also, we should consider clinical trial awareness, especially in, in the US as an example, but in many countries there still are gaps. So, could our CRA's be ambassadors in the community to also share a bit more because access to trials still remains a challenge you know, for many patients out there. So, we maybe need to think about opportunities that having very localized clinical research experts in that capacity.
00:29:31:14 [Lisa Feeney]: Excellent. Thanks, Jen. So, this has been a great discussion. I want to thank you for joining me today. This has really been enlightening. And as I said earlier, Jen, I think you and I have been twins and sort of our careers in industry. And I hope that more people will follow in our footsteps, really the people that are eager and excited about the work and clinical research in general and developing new therapies and options for the patients that to me, still motivates all of us to this day. So, what's your parting advice to the industry based on your years of observation and lessons learned and what do we need to do differently as an industry?
00:30:17:10 [Jennifer Sheller]: Yeah, and I sort of repeat myself on this topic, but we can't forget where we started. As you recall your mentor, I do as well. And I had no idea what clinical research was. I did a bachelor's in molecular biology, a master's in public health epidemiology. And I got a random phone call from one of my classmates who I actually worked with recently. It's a very small world, but I remember when somebody hired me, and they took a chance on me. I didn't have any experience. I had so many questions. We all need to do that. You know, it's the only way we're going to grow. And I would say for companies, CRO’s and sponsors, it's important if you have operational teams to make sure that you have an entry level role it falls into that catch 22, as we talked about earlier, you have to have a role where you don't mandate X number of years of experience so that you can truly grow and build the workforce. And without this, we're just going to end up in a talent war and we're not going to be focused on the right things like talent development. So, take a chance on someone is my advice. And then, we all need to take part in it.
00:31:26:12 [Lisa Feeney]: I wholeheartedly agree, Jen, and we have a Parexel CRA Training Academy where we're doing just that. And we're pulling in people and recruiting people again, finding the right people that want to do this for the right reasons and pulling them in and putting them through some very, very good training. We have simulations where they're walking into the pharmacy. I mean, it's all being done remote based these days, obviously. But very thorough and comprehensive training to set them up for success in the future. So, thanks again, Jen. At this time, I'll hand it back over to Kat for the Q and A.
00:32:08:08 [Katherine Cloninger]: So, thank you, Lisa and Jen for just such a really insightful discussion. And I think both of you have such a natural passion for what you do and within clinical research. I mean, it's easy to see that both of you made excellent CRA's and how you've progressed your careers to where you are today. So, we do have a number of questions and it would be interesting to hear both of your perspectives for the first one but ask Jennifer to start. So how do you assess candidates beyond general life science education and the basic requirements? I mean, what kind of qualities are important?
00:32:53:13 [Jennifer Sheller]: Yeah. And CV's are interesting. I like to look for sort of those above and beyond nuggets that are in the CV, not just, I did a CRA job at this company for two years. And but you know, I look for even in university experience, if they participated in different clubs or volunteers, just kind of looking at passion and roundedness you know, when people job hop really quickly, that is kind of a question. If I see that somebody has some resiliency and can stick it out at a company for a few years, at least it's not just looking to keep moving up in titles but can demonstrate progress. I think those are key components for me.
00:33:39:05 [Lisa Feeney]: Yeah. And it's somebody asked this, do you balance your checkbook? Right. So, I know that's a little bit odd, but attention to detail, right. I think and looking at data and putting the big picture together from a bunch of little pieces I think those are things we try and assess. Sometimes it's a little bit difficult. But really the looking at the data, many different pieces of data and putting the story together and that's not necessarily inherent in everyone.
00:34:17:08 [Katherine Cloninger]: So, for our next question, I think I'll start with Lisa this time. So, this question states when training CRA's new to the profession, how quickly can they be fully utilized and how do you ensure quality?
00:34:32:24 [Lisa Feeney]: Much quicker than one would envision? So, we actually have done the metrics and pulled data on this, which I recently reviewed. So, with regard to utilization and how quickly they can be fully utilized it is within, it can be as early as three or as late as six months. That's still very quick. So, we've looked at the data with regard to how quickly certainly they do call monitoring visits, they go through the training and then when they're released out on their own to do their own visit, they do co monitoring visits for all of the different visit types. And then when they're released to be ready to do their own visit, it can be as early as three months or up to six months. But that is still very quick for being fully utilized with regard to quality. Again, same exact thing. We looked at our experienced CRA's and then we looked at this CRA's that were new and had gone through recent training and were new to industry. And again, the quality metric data was astounding that their quality was on par with experienced CRA's within three to six months. And we looked at that in a number of different ways. One is you know, action items and follow up trip report timeliness, a number of different metrics.
00:36:03:21 [Katherine Cloninger]: And how would you answer that question, Lisa? Or Jen?
00:36:09:29 [Jennifer Sheller]: Yeah, and I agree with Lisa's points wholeheartedly, and if it's not number of years of experience, that will really tell you indicatively of quality, always despite what one thinks. And when you look at turnover time, it takes to replace someone right. And recruit. I mean, that three to six months is really nothing. But no, I agree with Lisa as assessment there, and I know organizations look at this routinely to see what the difference is, and it seems to be quite a surprise that it's not what we think.
00:36:44:09 [Lisa Feeney]: Yeah. Agreed. One thing if I could add, Kat, onto that is once you get that new person, that new trained resource and training specific on different clients, SOP systems processes, right. How to be a CRA within that organization, then it's about retaining them. Right. So, having a development plan for them and career path that's transparent to them, so they know what the options are and what the opportunities are.
00:37:17:18 [Katherine Cloninger]: So, our next question focuses on development. So, both of you might be able to answer this. But again, I'll start with Lisa here. What's development pathways are there for CRA's and what changes have you noticed in your career?
00:37:33:02 [Lisa Feeney]: Wow. I look back to when I was a CRA going back just a couple of years, and there were limited opportunities at that point coming out of the CRA position if you wanted to advance. There was basically, I think at the time it was pretty much study management was, was, and that took years to even get that as an option. Now there are so many different avenues that these folks can go into. They can be trial managers in country, they can be global study managers, they can move into data management, they can move into contracts and budgets. They can move into regulatory. There's just, and I know I'm probably missing quite a few others, but there really are unlimited opportunities. They can move into supply chain. Jen, what am I missing? I know there's more.
00:38:22:29 [Jennifer Sheller]: Yeah, I think of my own path. So, I was a CRA and then I became a clinical scientist you know, and then moved into in country manager, as you said, Lisa, and then global study manager and medical writing, there's people love to have the CRA foundational experience to do additional tasks or roles in clinical research. But I think the sky's the limit in some cases, right. It's just vast opportunities and some people want to stay at CRA for their career path. And that's great too.
00:38:59:12 [Katherine Cloninger]: And here's a follow-up question we just received. Are you seeing interest from student pharmacists as competition for industry fellowships, intensifies competition?
00:39:14:11 [Jennifer Sheller]; Can you repeat it? I'm sorry.
00:39:16:10 [Katherine Cloninger]: Are you seeing any growing interest from student pharmacists?
00:39:20:14 [Jennifer Sheller]: We do. Yeah. We do have a fellowship program too. And probably you guys do as well at Parexel, and I know we're doing some road shows too. One just occurred the other day at a pharmacy school. But there's lots of opportunity and growth and I think companies are probably looking to do more apprenticeships, fellowships, and what have you.
00:39:42:00 [Lisa Feeney]: Yeah. Kat, and actually at one of my son's universities where I've been speaking with them, one of the schools they want me to speak at is to the pharmacy students.
00:39:55:29 [Katherine Cloninger]: So, our next question takes a slightly different turn. Going back to sometimes the challenge of using the lesser experienced CRA's, what kind of support do you provide them if performance isn't quite at the expectation level for CRA's?
00:40:18:29 [Jennifer Sheller]: Yeah. And maybe Lisa I'll start. I mean, the manager plays a key role. Lisa and I were talking about this the other day. You really need to make sure your managers have enough time and maybe a different algorithm right. Of number of CRA's that are non-experienced. And those oversight visits and checks are really important. I think also the call monitoring component is really helpful. And then you know, checking in with stakeholders, but coaching and development retraining, maybe some of that simulation training on topics that they're challenged on you know, can become really important, but it's really important to hone in on where it is that the deficits are and what type of training would make sense for that.
00:41:04:24 [Lisa Feeney]: I agree. And having technology support in training is we find is very big. Sometimes the technology can be the most challenging part, right. They have the knowledge and the skills, but the technology is slipping them up some. And also, the mentor as Jen and I had spoken up before and having SMEs available to support them and a buddy, we buddy them up with someone who has who is in the role and has experienced in the role and sometimes just having another voice and another person to bounce ideas or thoughts or questions off of is important. Definitely the support as Jen stated, the manager, having the proper work allocation to be able to really add some support to those entry level folks.
00:41:56:21 [Katherine Cloninger]: So, I've got two, it looks like related questions to that. So, I think this is a popular topic. So one is, are your CRA's in training working on sponsor contracts during the training period or is there co monitoring on sites assigned to sponsors designated CRA's. Lisa, that might be a better question for you.
00:42:21:10 [Lisa Feeney]: So yes, they are working on sponsor trials. However, it is with agreement on the sponsor. And I can speak with Jen about this as an example, we were currently doing this with Merck. So, our CRA's have gone through the training, our Parexel CRA Training Academy. And then they go through not only not how to be a CRA, but how to be a CRA at Merck, right. So, it's really the learning the Merck's systems, SOP processes, and then begin working on that program. Again, we have a much lower manager allocation for those CRA’s, and we have mentors and buddies set up for them. And then the understanding that they will have co monitoring higher oversight during that first for six months, absolutely. And longer if need be.
00:43:16:09 [Jennifer Sheller]: Yeah. And I think what you had highlighted earlier, sharing the data on their performance is really important to share with sponsors because it gives that reassurance as well.
00:43:26:18 [Lisa Feeney]: Agreed. Full transparency.
00:43:29:27 [Katherine Cloninger]: So, Lisa, I believe you've partially answered the next question, which is how do you ensure the right get experience for pairing less experienced CRA's with seasoned CRA's? Is there an algorithm?
00:43:44:22 [Lisa Feeney]: Not necessarily, no. We don't have an algorithm. Jen, do you have anything to add on that?
00:43:52:22 [Jennifer Sheller]: No. And I think when you highlighted earlier, you have to make sure it's the right season CRA you know, who's interested to mentor and open because there would be nothing worse than a junior CRA really trying to learn and someone feeling they're just too busy. So, you have to give them the breadth of workload, but also, they have to be interested. And there's so many that are interested, but it's certainly not for everyone. So that to me is the more important, like qualitative pairing,
00:44:21:17 [Lisa Feeney]: Right. You don't want to force somebody to do this who's not interested, right? But there are, as Jen stated, there's a lot of interested parties out there that really want to do this, and they're passionate about it. And teaching others.
00:44:36:19 [Katherine Cloninger]: It looks like I've got another one that just came in. As we move into RBM and use technology to identify trends and outliers and more remote capabilities, the need for CRA's to go to sites is decreasing. Do you see the CRA's moving into remote hubs to provide remote monitoring?
00:45:00:12 [Jennifer Sheller]: Definitely with COVID there's so much remote monitoring happening, and some countries allow it more than others. Some have more strict regulations. And I think that still needs to be worked on, I think, especially in Europe, but we've done a tremendous amount of remote monitoring, but there's checks that you have to do to get out there. I mean I hear people go piloting Google glasses and other ways to see things, but I also come back to certainly there'll be maybe fewer onsite visits, but I do believe there is high value. And I know some companies send staff out just for the relationship component and yes, we can get good at that in virtual, but we all know it's not the same. But you know, checking drug and pharmacy, some sites have been creative, right. And having virtual ways to do it. We're not a hundred percent, I think we're years to go before that happens. But I think that relationship piece and the evolution of the CRA role will certainly continue. And as I mentioned before, I think even the role of getting out there and supporting community awareness and trial awareness, that's a tremendous gap that Zoom calls are not going to address. Right. So, there's still a lot of work. And I think to your question, this role will continue to evolve with that, but it's gonna take time.
00:46:20:27 [Katherine Cloninger]: And we just had another one come in and I'll ask which one of you might be best positioned to answer this. How do you see experienced drug safety professionals and clinical research, especially foreign trained experienced graduates?
00:46:39:24 [Jennifer Sheller]: Very valuable.
00:46:41:19 [Lisa Feeney]: Totally agree.
00:46:43:05 [Jennifer Sheller]: Yeah. And if there's specific questions or interests I think you'll share our contact information after happy to discuss but extremely valuable.
00:46:54:18 [Katherine Cloninger]: It looks like we've got a final question for Jen here. Can you comment on efforts within your company to expand diversity and inclusion in hiring?
00:47:06:17 [Jennifer Sheller]: Yeah. I mean, we have a lot underway. I'll touch on a few. I mean, for one, for each open position, at least in our global trial operations group, we are committed to making sure we have diverse candidates, the pool of diverse candidates. So, taking that extra effort and maybe going some non-traditional routes and sources of candidates, and then we're also committed to having diverse interviewers. So not just so we don't have those unconscious bias where you're picking the same type of person over and over. Cause maybe that's what you're familiar with but making sure we have diversity in those who are interviewing candidates, this coupled with, as I mentioned, getting out there and doing some road shows, we're doing our first career fair next week. And we're going to target different areas HBC news, for example, and other organizations where we can share, even with alumni, just more about potential career opportunities. So, we have lots underway, but those, I would say are just some of the direct elements in, in recruiting talent.
00:48:13:23 [Katherine Cloninger]: That's great. Looks like we're the end of our questions now. So that concludes today's webinar. I hope everyone found today's discussion educational, and if you have additional questions, the last thing that you'll see on the screen is an email if you want to get in touch. You've been such a great audience with a number of great questions and I hope everyone has a great day.
00:48:38:09 [Lisa Feeney]: Thank you.
In clinical development, functional service provider (FSP) outsourcing is an outsourcing model that gives biopharmaceutical companies the flexibility to contract out full or partial aspects of a specific function or functions to a contract research organization. A range of FSP models help biopharmaceutical companies manage the ebbs and flows of portfolio workflow staffing, with customized levels of oversight, administration and governance. An FSP can range from one or two employees to teams of 50 or 100+. FSP collaborations may involve the use of either the biopharmaceutical company’s or the research organization’s systems and processes. In some cases, it may involve a mix of both.
The most outsourced services in a functional service provider (FSP) model are clinical operations, site management, and data management. However, FSP outsourcing can include, but is not limited to:
There are a variety of benefits to the FSP outsourcing model. They can include:
Parexel’s FSP model options include:
Staff augmentation – Skilled staff who perform well-defined tasks for a functional area (such as clinical monitoring or study management roles), using Parexel’s systems and processes
Managed staff – Skilled staff and line management are provided by Parexel and work within the sponsor’s system and processes
FSP complete – Staff who comprise a functional discipline and use Parexel’s systems and processes
FSP flex – Skilled staff and line management who perform a specific volume of work, with unit-based pricing. Use of Parexel or sponsor systems and processes
Hybrid - A combination of FSP and full-service delivery models with flexible management, using either Parexel’s or a sponsor’s systems and processes
One of the benefits of an FSP is that it can accommodate your specific needs, whether that’s one or two staff or a team 100+. Additionally, it’s a scalable model which allows you to quickly ramp-up or down depending on your needs.
FSP Case Study: Urgent medical writing need to assist with dual FDA submissions
Is your FSP vision 2020?
EMWA Regulatory Matters Vol 29 Issue 1 March 2020 - J Wolfe and S Takidar
The Evolution of FSP Article
The Rise of FSP Outsourcing
FSP future view: the functional service provider model in 2025
Parexel FSP Culture Map
Putting AI to Work in Your Safety Program
Parexel FSP brochure
Elevate Your Medical Writing Team To Success
The FSP Workforce of the Future: Spotlight on CRAs
Podcast: Making the Most of Functional Service Provider (FSP) Relationships
Parexel FSP: Highly skilled people, where and when you need them
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