The Crucial Skills That All CRAs (Monitors) Need

Abstract: In the heavily regulated world of clinical research, clinical research associates (CRAs) are generally receiving all of the training in hard skills that they need to understand their role. What is often missing is training in the soft skills that will help them deal with the demands of the job, increase each CRA’s job satisfaction, and reduce churn (staff turnover), while allowing CRAs to have a healthy work-life balance. Examples of crucial soft skills include assertiveness, listening, and task efficiency. This article describes two pictures of a CRA’s life: one without these soft skills and one with soft skills training. This will illustrate the importance of paying attention to soft skills and offering CRAs appropriate training in soft skills along with training in hard skills.

Introduction

The clinical research industry generally focuses on hard skills and the training of CRAs on hard skills. Hard skills are the skills needed to operate the tools and systems of a job. A major part of the job of CRAs, however, is dealing with clinical research site staff, such as clinical investigators, site coordinators, data coordinators, and research nurses. CRAs need people skills to deal with people. Yet, this author feels that very few contract research organizations or pharmaceutical/device companies offer soft skills training to their CRAs.

Learning soft skills should improve work-life balance for CRAs. Work-life balance means something different to each person and changes over time. For the author, having a healthy work-life balance now means having time for her family and friends. Healthy work-life balance also means not doing reports at 11:58 PM to hit the midnight deadline or spending her weekends traveling to clinical research sites instead of being with her family.

Work-life balance is vital for our health and wellbeing. Also, work-life balance helps reduce potential stress and burnout and should make CRAs better at their jobs. When CRAs are rested and in control, they are able to focus, and many of the tasks CRAs are involved in require a high level of focus. Not having a healthy work-life balance often means that CRAs will be less productive and more prone to making mistakes. Having a healthy work-life balance and other soft skills should help CRAs become better at their job.

Definition of Soft Skills

Motivational speaker Simon Sinek says that soft skills are human skills. Ultimately, these are the skills that are needed for human beings to interact and work with each other (Table 1). While soft skills are the polar opposite of hard skills, training and practice can improve both hard skills and soft skills. Soft skills can enable CRAs to form effective collaborations with people, and inspire and motivate them. CRAs use soft skills every day in their jobs.

According to Ladders, the top soft skills that people include in their CV are:

• Interpersonal skills
• Being flexible/adaptable
• Leadership skills
• Having a good work ethic
• Positivity nature
• Being a team player¹

Positivity in the workplace would not be possible without other well-developed soft skills. This list shows how soft skills are inter-connected.

Why Soft Skills Are Important

Soft skills are important because the clinical research industry is all about people and soft skills help CRAs create effective collaborations with others. When a CRA inspires and motivates clinical research site staff to do great work, this, in turn, improves the quality of the studies. Higher quality studies will have fewer deviations and it follows that people should be happier and less likely to experience burnout.

While there are many soft skills, this article focuses on assertiveness, efficiency, and communication. The most common definition of assertiveness involves the ability to say “no”. There are, however, many other aspects of assertiveness. It is much more than a reaction to requests from stakeholders. Assertiveness relates to the ability to assert both our needs and wants (at work).

1. Assertiveness

Assertiveness is important because a CRA’s workload can vary depending on their level of assertiveness. Lack of assertiveness means that the CRA is likely to be swamped instead of having a manageable workload. If a CRA dos not have work-life balance and is also not vocal about their work and successes, they run the risk of being undervalued and underappreciated. This could harm the chances of promotion or any movement within a company.

Being assertive helps CRAs negotiate time off, pay increases, and promotions. Assertiveness is the ability to make decisions and to prioritize activities. Without effective prioritization, a CRA will usually not be able to complete all of their assigned tasks.

Table 2 provides an overview of decision-making for CRAs. Prioritization is at the core of a CRA’s job. While there are not enough hours in a day to do everything on the “To Do” list, not everything needs to be done now. Each CRA must decide what needs to be done now, what can be done later, and what may not need to be done at all. Study deadlines and key performance indicators may not always align. By prioritizing, CRAs will be able to continue working instead of being paralyzed by indecision or always waiting for more information.

CRAs must make the best decision possible with the information that is available at the time. If it later turns out that there was the wrong decision, it still may have been the right decision at the time. As Theodore Roosevelt said, “In any moment of decision, the best thing you can do is the right thing, the next best thing is the wrong thing, and the worst thing you can do is nothing.”

2. Efficiency

Efficiency does not mean using personal time to catch up on work. It is not being more efficient if an activity is accomplished at the cost of work-life balance. This exchange is generally unsustainable. Efficiency is working smarter, not harder. It includes doing things that need to be done and not doing things that do not need to be done. It is doing things in the best way possible within the allocated time. Also, efficiency is using as little effort as possible to do things as well as possible. Efficiency uses time and energy in a way that is not wasteful.

Efficiency is important because the CRA’s role is very demanding, with multiple overlapping deadlines that often need to be met at the same time. CRAs must be able to manage their time wisely in order to meet both their professional and personal goals. Ultimately, being efficient leads to a better work-life balance.

There are several ways for CRAs to be more efficient when working with clinical research sites (Table 3), including going paperless. The time used to take notes by hand and then to transcribe them into an electronic format is of great value. Entering information directly into a computer will save a great deal of time.

An efficient day starts the day before the day. CRAs should make a list of tasks to do for the next day before they log off for the current day. For example, if the CRA will be doing a site visit, they should think about the tasks that must absolutely be completed at the site. This encourages efficiency because working on site can be chaotic, with multiple things happening simultaneously. While the CRA must be able to react quickly, having previously documented priorities enables the CRA to complete the priority tasks even after addressing other things that come up during the site visit.

American author and lifestyle guru Tim Ferriss said, “Lack of time is actually lack of priorities.” CRAs must prioritize their tasks and automate as many repetitive actions as possible.

3. Communication

As liaisons between the sponsor and the clinical research site, CRAs are in tricky positions. They must inspire and motivate site staff to do great work on a study without having any administrative authority over the site staff. Communication skills are necessary to establish a good working relationship with the site staff. These are skills where demands, constructive feedback, and deadlines can be passed on without inducing panic or lowering morale.

Communication is key because CRAs work with people. CRAs must tailor their approach to each individual member of the site staff or study management. For example, some people like email reminders while others prefer to receive a list of tasks to be done with priorities clearly marked. Other people prefer telephone calls. Still other people do not want any reminders at all.

CRAs must establish genuine relationships with clinical research site staff and be able to listen carefully to all the messages that site staff convey, both verbally and non-verbally, in order to be able to motivate and support them. Listening is extremely important (Table 4). This soft skill will help CRAs learn more about site staff, and how to motivate and inspire them.

Listening will help CRAs learn about the strengths and weaknesses of clinical research site staff. CRAs will be able to emphasize site strengths and mitigate weaknesses. For example, if a site staff member does not like to file and has not filed documents sent after the last site visit, the CRA can discuss this with the staff member and look for a way to solve this problem. The solution could be simple, such as indicating in an email exactly where documents should be filed. Then the site staff member can quickly and efficiently do the filing correctly.

Ultimately, listening will enable CRAs to build genuine relationships with site staff that will result in more efficiency and better work-life balance for everyone.

Soft Skills in Action

The following five scenarios show soft skills in action.

n the first scenario, patient folders are not ready or made available when the CRA arrives at the clinical research site despite the CRA having highlighted in the confirmation letter that these are a necessary component of the visit. Instead of waiting, the CRA should use the soft skill of communication to emphasize to site staff the importance of having the patient notes available for review ASAP.

Also, the CRA should communicate the situation with their clinical trial manager or project manager. This gives the clinical trial manager or project manager the opportunity to decide whether to escalate the situation to the sponsor and whether there are any other priorities that the CRA can be working on instead of reviewing the patient folders. The CRA should also consider what they can do while waiting for the patient folders and share this with their manager. In this scenario, soft skills are used to keep everyone in the loop and to avoid further surprises.

The second scenario is very common. The CRA has a scheduled meeting with the clinical investigator, but the clinical investigator is not available. The CRA should not wait outside of the clinical investigator’s office and hope for the best.

Instead, the CRA might message the clinical investigator and state that they appreciate that the clinical investigator is busy and may be running behind schedule. However, the CRA is also busy and cannot sit around and wait for the clinical investigator because the CRA has a packed agenda for the day while on site. The CRA could note that the clinical investigator will find them in the monitoring room when the clinical investigator becomes available. Thus, the CRA is able to get on with their work while also keeping the clinical investigator informed about where to find the CRA.

In the third scenario, a research nurse asks the CRA for help answering every single electronic case report form query during the site visit. The CRA may not be able to sit down with the research nurse and go through all of the queries one by one. That would usually be unplanned work and would be done at the expense of other planned tasks.

The CRA may carefully explain to the research nurse that this item review is not the aim of the current site visit, but that the research nurse is welcome to ask questions during the site visit if something specific is not clear. Otherwise, the CRA may suggest that the research nurse can email the CRA with the questions, or perhaps schedule a teleconference so the queries can be resolved at another time. Also, the CRA should listen to the research nurse to determine whether the nurse needs help with a specific issue or whether there is a systemic issue that needs to be addressed that may need additional time outside of the site visit.

In the fourth scenario, the CRA wants to do as much source data verification as possible in any spare time between the different meetings throughout the day. The CRA should not stay at the clinical research site longer than planned, trying to do as much source data verification as possible to get ahead of a deadline. Doing this could mean that the CRA risks missing their flight home, which could require staying away from home an extra night.

Instead, the CRA should leave at the planned departure time, with a healthy buffer to get to the airport in plenty of time for the flight. The CRA should wrap up the site visit properly and close the day calmly and confidently. If necessary, the CRA can add an extra day to the next site visit to handle any missed source data verification. This use of soft skills helps the CRA prioritize what is most important and to be more efficient.

In the fifth scenario, the CRA asks the clinical research site for a visit on May 19th. The site cannot do a site visit on that day, however, they are available on June 22nd. The CRA is not sure at that moment whether that date works.

The CRA should consider not delaying the decision on confirming the new date because they have to check other activities. Waiting on other input to confirm the new date usually wastes time. Instead, the CRA should make a decision that day based on the information that is available and if it becomes necessary, to re-evaluate the decision later. For example, if the CRA finds out later that the date does not work, the site visit can be rescheduled. The author believes that making the decision there and then and accepting the new date makes the CRA more efficient. Otherwise, initially scheduling a site visit usually requires a few emails back and forth between the CRA and the site.

Conclusion

Without the use of crucial soft skills, a CRA’s life will often become very difficult. Days spent at clinical research sites can be very stressful and CRAs may begin to lose motivation. Most likely, they may want to change their careers. For companies, lack of soft skills by CRAs results in a higher potential for expensive revisits, not meeting deadlines, and higher costs to retrain new CRAs when CRAs burn out and leave. When an experienced CRA walks out the door study quality often decreases.

The CRA’s life when utilizing soft skills will look completely different than without such skills (Table 5). Training in soft skills can tremendously affect the CRA’s life and can produce gains for the company. If CRAs are not overworked or stressed out, they should have time for their families and time to establish greater relationships with clinical research site staff. Site staff will be meeting their deadlines because they are prioritizing the CRA’s activities appropriately. They should feel more motivated and inspired. The CRAs should enjoy going to their sites and the site staff will enjoy having the CRA visit them.

With soft skills, the CRA will be able to build up the culture of the company and hopefully will stay there. They will have additional potential to be promoted within the company.

While soft skills training has long been ignored by many organizations, such training can massively improve the lives of CRAs and the people who work around them. Soft skills can also improve many aspects of the quality of clinical trials.

A healthy work-life balance is key to thriving as a CRA for the long haul. Being assertive is essential in being an effective CRA. Communication skills are key contributors, and a large part of communication skills is being a diligent, active listener.

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TABLE 1

Soft Skills

• Any interaction with other people
• Whether conscious or sub-conscious, people are always using soft skills
• Example of soft skills:
  • Empathy
  • Listening
  • General People Skills
• The polar opposite of hard skills:
  • Technical skills needed to use job tools and systems
  • Training and practice can improve soft skills and hard skills
• Benefits of soft skills:
  • Connecting with people
  • Better understanding of what is important to the other person
  • Ability to inspire and motivate other people

TABLE 2

Decision-Making for CRAs

• Prioritization is at the core of a CRAs job:
  • Not enough hours in a day to do everything
  • But not everything needs to be done now
  • Decide what to do now, and what to do later
• Study deadlines and key performances indicators may not always align:
  • Additional stakeholder requests must be handled appropriately
  • By deciding on priority, the CRA gets something done
  • Make the best decision possible with the information available at the time
• Justify Decision:
  • Lack of assertiveness in defending choices can make the CRA appear incompetent
• Learn from each experience and each decision

TABLE 3

Simple Steps to be More Efficient as a CRA

• Go paperless:
  • Time used to write and trasncribe notes electronically is lost time
• Make a list for tomorrow:
  • At the end of the day, make a list of tasks to do the next day
  • Mark this planning time in the calendar to ensure that this gets done
• Prioritize:
  • Prioritize based on key performance indicators
• Automate:
  • Try to automate as many repetitive actions as possible
  • Make templates for doing repetitive activities

TABLE 4

Benefits of Listening Skills

• Learning about others and how to motivate and inspire them
• Focusing on strengths and mitigate weakness
• Understanding what is important to site staff and knowing how to support them
• Form genuine relationships with site staff and other stakeholders
• Creating more efficiency and better work-life balance

TABLE 5

The CRAs Life with Crucial Soft Skills

• Short-term consequences:
  • For Individuals:
    • Higher efficiency
    • Motivation
    • Sense of pride and achievement
  • For Companies
    • Deadlines met
    • Fewer Days on Site
    • Less training costs
• Long-term Consequences:
  • For Individuals:
    • Happy relationships
    • Career progression
    • Healthy work-life balance
  • For Companies
    • Reduced churn (turnover)
    • Higher-quality work
    • Medicines and other products brought to market quicker

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References

1. Ladders. List of top soft skills employers value (to use on your resume). July 28, 2022. https://www.theladders.com/career-advice/top-soft-skills-for-resumes. Accessed 6/7/23.