By Aga Finlayson, founder and director, White Wisteria Academy
Clinical trials are increasingly complex. There are more data points to collect, input into eCRF, and verify. There are more study procedures. There are also more studies being run and less time allocated for them. Not to mention, clinical research professionals (CRPs) are forced to multitask at all times, and their tasks are often dictated by urgent calls and emails. All of this contributes to the average CRP being bombarded with strenuous assignments, often above those of a full-time equivalent.
In this environment, efficiency is a forgotten ideal. To-do lists are way too long, and sometimes not even one item gets crossed off in a day full of ad-hoc tasks. If a CRP gets to finish their lunch, that’s a good day. Imagine dealing with that in the long term. This level of harried commitment is not because there is a database lock or there is a new study being set up. This is the norm all the time. The effect? CRPs suffer burnout, and trials run off the rails.
From the CRP’s point of view, this is bad news. Burnout happens, and people often quit. According to A New Way To Work, it can take between two and five years for a person to recover from burnout.1 Sometimes that person never returns to the same career, shrinking an already shallow talent pool.
From the sponsor, CRO, and site points of view, site staff quitting is equally bad. High churn means experience and knowledge are walking out the door. Efficiency and team morale are lost. This may cause the study team to be demotivated and start making mistakes, which can lead to delays and poor-quality output. Delays might even require a study to be rescued, pushing up costs and timelines even further.
When delays and quality issues compound, the overall study cost increases. Sponsors stand to lose $660,000 to $8 million each day when the product launch is delayed.2 But there is more. What about time to market? Not only do delays cost more, but not being on the market means loss of potential revenue in commercialization.
So, what does this have to do with a CRP’s skillset? As you read the case studies below, consider the single soft skill that is absent in each.
The “Perfect” Study
Study team “A” is working on a trial that seemingly has no issues. The new clinical research associate (CRA) is doing an acceptable job. There are almost no deviations, no issues, nothing to report. Study team meetings bring few updates, and given that everyone is busy with other studies, the meetings are often cancelled.
Suddenly, the sponsor starts questioning the fact that things are too perfect. Reports seem rather general. Further checks and investigations uncover a complete lack of communication in the way the CRO managed the study. Until this point, the sponsor didn’t press for updates if they CRO didn’t volunteer them. It turns out that the study team was not talking on a regular basis, the project manager was busy with other issues, and there were two CRA changes in the last year. Everyone was so busy that no one thought to do any quality spot checks.
Then, the sponsor joins the CRA for a site visit and uncovers chaos. Source documents are messy, deviations have gone unreported, site staff were not re-trained, and quality issues are glaring. It turns out the CRA is overallocated but did not communicate it to their line manager. The PM is also busy and did not probe the CRA when no issues were being reported. The site was not communicating that they struggled, because staff was pulled in too many directions.
At this point, the sponsor is frustrated and alarmed with the quality issues. They decide that the only remedy is to rescue the study and so engages another CRO to take over. The new CRO then needs to “clean up” and review the work performed by the former CRO to determine what solutions need implementing.
Needless to say, this process was never part of the plan. No clinical trial has a rescue in their study timelines. It is a complete waste of time, money, and resources. A delayed time to market is not a surprise; it’s a given.
Scaring Patients Away
A research nurse (RN) works at a busy clinical research site where she juggles multiple studies. She suddenly realizes that today is the first randomization visit on a new study, and she is unprepared. The new patient arrives on site, and the nurse is frantically looking for all the documents for the visit. She doesn’t know how to proceed, makes errors, and panics in front of the patient. She needs to ask a colleague for help and contacts the CRA with questions.
This unpreparedness starts impacting not only the nurse’s work but has a ripple effect. She calls a CRA, and that CRA must drop everything and help her. The patient grows more and more uncomfortable, witnessing the RN fumble with study procedures. Eventually, the patient goes home and discusses with their family how the randomization visit went. Not having confidence in the process, the patient is not able to instill it into their family. The patient decides to withdraw.
Overworked And Under Resourced
A senior study start-up (SSU) associate at a busy CRO is already allocated to too many studies and is worried about how her many commitments will affect the quality of her work. Rather than raising her concern with her line manager, she keeps it to herself.
At her next one-to-one meeting with her line manager, the manager asks if she can take one more study. She says yes, wanting to help and to do the right thing. However, she is at her limit and instantly regrets accepting the extra work. She is already using personal time in the evenings and on the weekends to stay afloat on her existing studies. Now, more personal time will be sacrificed.
Fast forward two months, and the SSU associate submits her resignation notice. She quits without having another job lined up. She has no plan for her future, and she is too exhausted to look beyond the week.
Teaching Your Workforce To Speak Up & Stand Up
What do these cases have in common? These CRPs lack a specific soft skill that would help them to stand up for themselves, the patients, and the critical work at hand. They are overwhelmed, but they are not able to communicate that before it is too late. Working overtime for extended periods of time makes them unable to prioritize correctly or ask for help. They are not able to build a healthy work-life balance. They are not able to say no to extra assignments, and the only recourse left is quitting. They are not assertive.
Our industry attracts people who are selfless and caring, but they often do not know how to care for themselves. Only an assertive CRP is able to keep their workload at a manageable level so that the output quality remains high.
There is good news in this, though. Assertiveness is a skill; it can be learned and improved upon.
CRPs often go through a whole battery of training when first joining an organization. However, none or very little of that training is on soft skills, let alone on assertiveness. While employees can use all study related tools proficiently, they often do not have the tools to communicate efficiently, succinctly, and frequently. Training on assertiveness would help to solve problems not only with effective communication but also with poor prioritization, overworking, and hurried work delivered at the last minute or late.
Turnover Rate Is Alarmingly High
According to a BDO report3, in 2018, the average CRA turnover rate reached 29% in the U.S. and remained at 26% in 2019 and 2020. It further escalated to 28% in 2021. Outside of the U.S., the turnover was at 16% in 2018, 20% in 2019, and 15% in 2020, climaxing at a staggering 29% in 2021. This upward trend is alarming on its own, and if we compare it to another industry, say legal, it looks even worse. Legal claims to be having a bad year when turnover is 17% among the top 10 firms.4
We need to do better as an industry. There are many ways to retain staff. The internet is full of articles suggesting creative perks, bonuses, and ways to unwind and recharge. Yet many of these suggestions overlook the fact that our industry attracts people who are not assertive. They are not able to ensure their work-life balance is in order. They are outstanding in helping others, but in being selfless, they lose themselves.
Importantly, equipping the workforce with improved assertiveness is going to help retain them. In the current clinical research landscape, the fight for top talent is real. There is a shortage of experienced professionals and when they leave, it wreaks havoc from study efficiency all the way to patient recruitment and retention.
When CRPs’ assertiveness improves, good things can happen. When staff are assertive in communicating their wants and needs, they will not be exhausted, burnt out, or handing in their notice. People will work effectively using the efficiency systems they had time to put in place. There will be less time allocated for training new staff and creating new team dynamics. Planning will be more accurate, and timelines will need fewer adjustments. As a result, time to market just might be reduced.
Training Provides Payoffs
Judging by responses of those attending international conferences, I am encouraged to know industry is starting to take soft skills seriously. Everyone wants to know what resources are available. I recommend including a soft skills specialist to analyze your requirements and create bespoke courses in soft skills. Identifying existing issues and linking them to soft skills are critical for targeted, worthwhile training.
Everyone is busy in our industry and as much as it is about respecting the precious resource of time, it also is about efficiently tackling the root cause issues. In my experience, assertiveness is one of the foundations that many other soft skills are built on. Once you are assertive, you are able to make sure your workload is appropriate and build a healthy work-life balance. That is a good start.
About The Author:
Agnieszka Finlayson, MSc, MA is the founder and director of White Wisteria Academy, which focuses on soft skills training for clinical research professionals. Agnieszka has been working in clinical research for over 15 years, ranging from pharmaceutical startups to global CROs. She is passionate about sharing her experiences and knowledge with her peers and newcomers alike. Agnieszka believes that the development and maintenance of soft skills such as communication, assertiveness, and empathy are critical in order to achieve high quality on studies. Through White Wisteria Academy, Agnieszka has created online courses, and she also consults for CROs and pharmas on how to improve study efficiency. She is a published author on the subject of soft skills in clinical research, which she also presented at ACRP and SOCRA conferences. Connect with Agnieszka on LinkedIn or email her at firstname.lastname@example.org.