Clinical Researcher—November 2021 (Volume 35, Issue 8)

PEER REVIEWED

Agnieszka Finlayson, MSc, MA

 

Before the COVID-19 pandemic, soft skills for use in clinical trial environments were already challenged,{1} with each clinical research associate (CRA) left to his or her own devices in forming and improving upon these skills. CRAs hardly, if ever, received formal training on what soft skills are needed to thrive in this demanding role; only with time and experience could they, like anyone else, strengthen their communication practices.

Without formal training, the most natural way for humans to communicate effectively is in person, which is what traveling CRAs relied upon. However, during lockdown, any sort of face-to-face communication was restricted. CRAs could communicate with busy sites only through digital means. Site staff still needed support and training, but CRAs no longer had the luxury of doing this while being present physically for utilizing both verbal and non-verbal cues to build rapport with site staff.

As with other industries, the clinical research enterprise turned to online tools to get important work done in pandemic conditions. Teleconferences became video calls, onsite visits became remote visits, and face-to-face conversation became e-mails. As these were not proper substitutes for the lack of physical interaction, the difficulty that CRAs already faced with training and motivating site staff was intensified.

While CRAs are intensively trained in hard skills such as source data verification or investigational medicinal product accountability, as well as the systems required to support their work on the study, soft skills are usually ignored. It was as if forgotten that a CRA’s role is effectively dealing with people—be they site staff, fellow CRAs, or vendors. The time for CRAs to start focusing on their soft skills has already passed us; however, the importance of not doing it has never been laid as bare as it is now.

The author of this article believes that post-pandemic online courses are a perfect medium to teach any required soft skills, as has been written about by others in Clinical Researcher.{2} By being better at communicating and dealing with people, CRAs (as with everyone involved in clinical trials) can not only improve the quality and efficiency of their studies, but they can improve the quality and efficiency of their lives.

What are Soft Skills?

Soft skills are human skills,{3} as Simon Sinek puts it. They are a combination of various capabilities and ways in which we interact with others. Empathy, communication, listening, and general “people skills” are all examples of soft skills. They are the qualities which distinguish us from each other and from any machine or a robot.

Through an optimal use of these skills, we can connect with other people. We can understand what is important to others and, through this, we can communicate in a way that motivates and inspires them. Soft skills can be improved with training, practice, and time.

The opposite of soft skills are hard skills—the things you need to know in order to do your job. These are normally industry- and job-specific skills and, as is the case with CRAs, are also attained through training, practice, and time.

How Do Soft Skills Apply to the CRA Role?

Empathy

CRAs work in a highly regulated yet dynamic environment. Functions around CRAs may be under various pressures while trying to meet conflicting deadlines. CRAs have to be empathetic to the people they work with to keep doing their work without being demotivated or taking things personally. If site staff are stressed and struggling and CRAs cannot empathize with them, it will be almost impossible for CRAs to build great collaborative relationships{4} with sites.

Communication

CRAs are a liaison between the sponsor and the site staff. Study management may sometimes need to achieve aggressive deadlines and inadvertently may put pressure on CRAs. However, site staff need to stay focused and motivated. It is therefore necessary for CRAs to communicate urgency to, and help set priorities for, site staff, but at the same time not induce panic or stress because that would be counterproductive.

Each site is different in what support it needs from CRAs to do the best work. For instance, some site staff like phone call reminders to do something, others prefer e-mail reminders, while others get offended by either. Some people require e-mails that are quick to read and a list of tasks that are arranged by priority, while others require explicit and detailed instructions.

CRAs must tailor their approach to each individual. Consequently, CRAs have to be able to listen carefully to all the messages that site staff convey, both verbally and non-verbally. CRAs have to look for cues about their site’s level of workload in order to have the site prepared for a deadline and be confident it can meet that target.

Motivation

CRAs are in a unique position of having to motivate their site staff and create effective collaboration without having any mandate over them. Without soft skills, this will simply not be possible. Site staff are usually allocated to multiple studies and CRAs need to stay on top of them—no matter how many other pots they are stirring—for the good of their particular sponsor’s study. CRAs can help site staff be effective, efficient, and motivated to do a high-quality job. This is a key area where CRAs with strong soft skills will prevail over those with weaker soft skills.

Before the Pandemic

Normally, people exercise their soft skills face-to-face. When next to another human being, we use our social skills and emotional intelligence to “read” people and respond appropriately in order to build rapport and communicate effectively. Once a relationship with a study team or site staff is established in person, that usually increases collaboration.

When CRAs or site staff find themselves inevitably under pressure, they will be more forgiving due to the rapport that has already been established. Because site staff have met their CRA in person, they will trust them in the future and vice versa.

When CRAs join a new company, such as a contract research organization (CRO), they get a lot of training. However, a vast majority of this training is about hard skills and technical aspects of the job: the tenets of Good Clinical Practice, creating and following standard operating procedures and study-specific procedures, etc. As CRAs develop and gain more experience, they are assigned to more complex studies and receive more study-specific training. CRAs become well-trained and well-prepared for the complexity posed by the indications and protocols they are working on, but only on a technical level.

Unfortunately, at no time are CRAs provided with extensive soft skills training, if they are provided with any at all. Often, CRAs need to rely on their own wits and support and advice from other CRAs through informal networks in order to get their tasks completed. This state of affairs is tolerated because at the end of the day, CRAs meet their goals and it is physical interactions that help get them over the line.

During the Pandemic

The COVID-19 pandemic brings challenges at every level for everyone. Lockdowns, travel bans, and social distancing each bring their own set of difficulties that CRAs, like anyone else, must overcome. In-person interaction, with all its fragile elements that were previously done subconsciously and taken for granted, is severely restricted.

CRAs can no longer attend site visits. Everything moves online and is done remotely. In addition, CRAs have to train site staff in this new way of doing things. Soft skills that were already lagging behind hard skills become even more essential. Across the industry, new tools and new processes are quickly adopted, causing friction and hassle in what was already a fragile network of relationships. These new tools bring with them new challenges.

Zoom Etiquette

Video conferencing comes to the fore to replace face-to-face meetings. Even though this mode of communication is not exactly new, the extent to which we are currently using it is unprecedented. Tools like Zoom, Teams, and Skype, all video-conferencing interfaces, become part of our human interaction with anyone who does not live in our household. Out of all the available video conferencing tools, Zoom is probably the most famous for both the right and wrong reasons. Therefore, this article will focus on Zoom as an example of all similar tools.

Because communicating face to face is nothing like communicating on Zoom, we needed some guidelines to convey our message via this medium as accurately as possible. Collectively and informally, participants in Zoom calls created a set of rules to communicate online effectively called Zoom etiquette. While Zoom etiquette is difficult to define and out of scope of this article, one key example is through eye contact.

When participating in a video call, each participant has to make a choice between looking directly into the camera (to give the other participants the illusion of having a real physical conversation) or looking at the monitor (to get non-verbal cues via their video streams). This means that it is now impossible to have a conversation and hold eye contact at the same time.

Any video conversation will always lack the synchrony of a conversation as you may miss facial expressions when looking at the camera, or other participants may miss your gestures as they are looking at their camera while mimicking physical eye contact (instead of looking at their monitor).

Zoom etiquette rules come about to lower expectations and tell participants that even if others are not “looking” at us through their cameras, it is because they are paying attention to what we say, hence looking at their monitor. This is particularly true if people’s setups mean their cameras are out of position relative to their monitors.

Through these video calls, soft skills are “working overtime.” The disconnect between video and face to face communication needs to be compensated with soft skills in order to foster a positive human-to-human interaction. To top it all off, the psychological reward that we would normally receive from physical communication which would make us alert is not really there.{5} This leads to Zoom fatigue.

Zoom Fatigue

Zoom fatigue is a term used to describe the tiredness, anxiety, or worry resulting from overusing virtual platforms. Video conferences are mentally exhausting.{6} Sensory overload may also be playing a part. We are now using our eyes, ears, and facial expressions in disjointed ways which we are not used to.

Staring at a monitor all day is tiring. The lack of movement and the required high level of focus all come together to exhaust us. On the top of it, we are forced to “overuse” our soft skills, foster attentiveness while on camera, and we have to do all this without the natural energy boost from a physical conversation.

Zoom fatigue can be contagious. When you are speaking to somebody who appears tired, that tiredness can transfer to you. If it is your first call for the day and their sixth, you will know it and start feeling their fatigue, too. This, unfortunately, is the flip side of being an empathetic CRA.

Languishing

There is also an emotional, long-term effect of the pandemic. A feeling of stagnation and emptiness that a lot of us are feeling is known as languishing. It is claimed to be the most dominant emotion of 2021.{7} Adam Grant explains languishing as an emotion that lies between depression and flourishing. Critically, we need soft skills to combat it—we need to feel connected to others, to be a part of a community.

CRAs are in a great position here because of the meaningful nature of the work they do. As an industry, we need to keep reminding ourselves of the good we are collectively doing and stay focused on achieving our goals. We need to make sure that we remember the bigger picture of getting the medicine to market and the patients who will benefit.

After the Pandemic

What will become of the skills and solutions that we used during the pandemic when the dust settles and we reach a “new normal”? It is hard to think that everything we learned during the pandemic (e.g., communicating through video conferencing, remote working, and online training) will fade away as our state of practice reverts to how it was before.

A balance of the “old” and “new” must be the way forward. In this, the “old” will include tasks such as making traditional physical site visits when required or attending investigator meetings and seeing everyone involved in a study face to face. Meanwhile, the “new” may include further remote or flexible working, more remote monitoring visits than prior to the pandemic, and an appreciation of when to use video conferencing.

Ultimately, we will all organize our time differently and start prioritizing human connections above all. In-person interaction and time spent with family and friends will prevail over superficial interactions.

If these auxiliary interactions can be permanently shifted online, much like during lockdown, we can gain more valuable time for ourselves. Furthermore, if more “static” content can be consumed via online pre-recorded media, then we can further gain time and flexibility by eliminating commutes and pausing or playing back content as needed.

Time to Appreciate Soft Skills

No matter what the outcome is after the pandemic has subsided, what has been made clear is that our current lack of focus on soft skills in general, let alone their training and development, is not a sustainable position. We managed to stumble our way through awkward Zoom calls and e-mails without context or tone of voice. These lessons will not go away quickly, nor will the repercussions of not being prepared.

Soft skills training and development must go hand-in-hand with hard skills training and development. By ignoring effectively half of a CRA’s role, pharmaceutical companies and CROs are only harming themselves, their studies, and ultimately the investigational medicinal product.

The Right Tool for the Job

One of the instrumental methods that CRAs, and indeed anyone else in clinical research, should be utilizing going forward is the medium of online courses. We have collectively enjoyed not losing time on commutes or long travel to training sessions at the office where in-person training can have negligible results.

Instead, taking our lessons learned from the pandemic, we can shift all of this online. Online courses allow CRAs to complete them at their leisure, working in-between their personal and professional needs. As new training is made available, it is simply posted online for CRAs to complete. Much like hard skills training, more advanced soft skills courses can be made available to CRAs as they progress in their careers.

While it took a global pandemic to shake the status quo, ultimately this disruption will be of benefit to the industry as a whole. CROs and pharmaceutical companies massively benefit by having CRAs trained in both hard and soft skills, as this will lead to having more efficient sites, reduced study costs (compared to before the pandemic), and higher quality studies with the potential of going to market sooner. Meanwhile, CRAs are more likely to be happier with their roles leading to lower churn and creating an upwards spiral of skill and experience. Ultimately, a healthy work-life balance for CRAs (and indeed all clinical research professionals) means better studies and better results.

References

1. https://www.youtube.com/watch?v=o9uzJ0LgvT0&t=201s
2. https://www.forbes.com/sites/amyblaschka/2019/02/19/the-soft-skill-gary-vaynerchuk-simon-sinek-and-oprah-winfrey-say-is-crucial-for-leaders/?sh=28ca76d84e9b
3. https://www.psychiatrictimes.com/view/psychological-exploration-zoom-fatigue
4. https://www.psychologytoday.com/us/blog/the-desk-the-mental-health-lawyer/202005/virtual-platforms-are-helpful-tools-can-add-our-stress
5. https://www.nytimes.com/2021/04/19/well/mind/covid-mental-health-languishing.html

Agnieszka Finlayson, MSc, MA, (aga@whitewisteriaacademy.com) is Founder and Director of the White Wisteria Academy, which focuses on training for clinical research associates and is based in the United Kingdom.