From Good to Great – The One Skill Great CRAs Possess

To be a great CRA, one skill is needed: active listening.

What skill differentiates a good clinical research associate (CRA) from a great CRA?

1. Knowledge of clinical processes and the regulations that govern them?
2. Ability to be flexible with travel and work schedules?
3. Ability to spot errors that could gravely impact data and ultimately patient safety?
4. A relentless zeal for ensuring assigned sites are ”buttoned up?“

The answer- none of the above.

Don't get me wrong, these skills are important and they are point of entry for a good CRA. These skills are expected as a minimum set of skills to be hired for the job of CRA but they are not the skills that differentiate a great CRA.

What sets a good CRA apart from a great CRA?

A great CRA knows how to spot a troubled site AND turn it around. Or better yet, spot a site headed for trouble and turn it around before it gets there. A great CRA is proactive, engaged and a partner with her/his sites. Let's face it; sites don't want to be in trouble. Sites want to do a good job, keep enrollment numbers up, and be successful on their own terms.

None of us enjoy dealing with a persistently troublesome site. It is uncomfortable, unproductive and exhausting. Troublesome sites take up much of our most precious resource as CRAs our time. Yet, too often we label sites as “troublesome” and apply the same tactics over and over again:

1. Identify the deficiency.
2. Discuss the deficiency with the site. (That's our job, after all).
3. Explain what the site needs to do to correct the problem.
4. Have this conversation again at the next site visit – because nothing has changed.

We all know (and could write volumes on) the downstream effects of poor site performance (delayed product approval, to name just one). So what's a CRA to do? You've explained to site staff countless times what is wrong and how to correct it (CAPA this, CAPA that) and yet the issues and problems remain. Can you really have an impact or should you write them off, because after all, in large studies, not every site is going to be a success?

The reality is – if you are a great CRA you can do a lot to help these sites. To be a great CRA one key skill is needed: active listening.

What is active listening?

Active listening is a communication technique that fosters understanding and ultimately builds relationships. Active listening requires you to:

• Suspend judgment
• Seek first to understand
• Not take things personally

Active listening is a fancy set of words for genuinely trying to understand where the other person is coming from. In this case, the other person is the study coordinator or the site staff.

Ask yourself this:

In your discussion with your “troubled sites,” who does most of the talking? If you responded with “I do,” then you are likely missing a huge opportunity to help your sites become successful.

By employing active listening, you will be able to better understand the root cause of the issue(s) and provide a better solution than a “standard” CAPA that lacks meaning or relevance to the site. And the bonus for you and the study is this: people like to feel heard. When you make a genuine attempt to hear the study coordinator or other site staff, they start to open up and a better relationship begins to form. Better relationships typically lead to better results.

How do you actively listen?

You execute this 5 Step Active Listening Process.

Step 1: Open the dialog. Meaning create an environment for good communication to happen. You can do this by:

• Giving the speaker your full attention and minimizing distractions
  • Shut your laptop lid
  • Turn off your cell phone
  • Stop doing what you are doing (and pay attention)
• Considering the speaker’s background
  • Nationality and culture
  • Time in current role
  • Clinical study experience
• Keeping an open mind and being aware of potential barriers. The most common barriers are a person’s own judgments, attitudes, biases, and prejudices but others include:
  • Lack of interest
  • Fatigue
  • Distractions
  • Environment

Step 2: Listen attentively. You can do this by:

• Leading with your ears
  • Do not think about your “next move” when hearing someone else speak. Listen to what they are saying.
• Displaying signs of listening
  • Make eye contact
  • Provide verbal affirmation
  • Lean forward
  • Do not interrupt
• In the case where the speaker is angry, let her/him get her/his poison out
  • Wait until s/he is truly done
  • Do not take it personally
  • Ask for more. “Is there anything else that's been frustrating for you?”
  • Seek first to understand

Step 3: Interpret. Meaning make sure you understand what they said by:

• Confirming what you've heard
• Parroting back
• Leading with a non-threatening and non-defensive tone. Use phrases like:
  • “Let me see if I'm hearing you correctly, you mentioned you have…”
  • “You said something interesting. <paraphrase> Did I hear that correctly?”
  • “Let's make sure I'm hearing you correctly”
• Paraphrasing the speaker's words
  • Note: this does not mean you are agreeing with them, it is just restating what you heard

Note: Step 3 is the most challenging step and most often forgotten. Practicing will help.

Step 4: Evaluate. Consider the information the speaker provided by:

• Clarifying any open points or areas for miscommunication. If s/he says something that you need more detail on – ask for it
  • “Tell me more about ________.”
  • If you don't think they are telling the whole story, ask for it.
• Listening to your inner voice
  • If something seems off or does not make sense, ask questions until you have a better understanding
  • If it still seems a little “off” when further explained, keep a note of it and see if it ties into something later
• Avoiding the use of trigger words or hot topics
  • Fraudulent
  • Really?
  • Violation
  • Falsification
• Calling feelings/emotions out on the table in a non-threatening way
  • “I'm sensing some <emotion> (frustration, fear), am I off base? Tell me why you feel that way.”
  • “You seem to feel passionately about this topic. Is that because…”

Step 5: Act! You now did a great job of listening and understanding what the speaker was communicating. Continue to build the relationship by ensuring proper follow up. You can do this by:

• Leaving conversations knowing, and if appropriate, driving the next steps
  • Identify who is responsible for a task and assigning a deadline
  • Send a follow-up email confirming your understanding of the tasks and deadlines set
• Using words that show you want to help
  • “How do you want to proceed?  What's important to you?”
  • “It's important to me that this gets resolved to your satisfaction.”
• Being reliable
• Following up

Above all, when you employ active listening, be genuine – the site will know when you're not

Practice makes perfect

This 5 Step Active Listening Process is not always easy. Our nature, at least in the United States, is to keep the focus of our conversations on ourselves rather than the speaker. To mitigate this tendency you need to practice this process. I teach a course called “The Highly Effective CRA: Soft Skills for Taking Your Work to the Next Level.” In this course we conduct a role play activity where a CRA needs to actively listen to better understand what is happening at the site. Almost every attendee who participates in this role play activity ultimately learns that s/he might have listened, but s/he did not actively listen. Bottom line – it takes practice, practice, practice to perfect your active listening skills. See if you can find a partner to practice active listening prior to performing your next site visit.

Change your monologue into a dialogue

The next time you sit down with the staff at a troublesome site, break your old habit of pointing out the issues that need attention in the hopes that they will fix them. Most likely, the site knows what needs attention. Telling them again is only frustrating to them. Bottom line: they need a different approach.

Try a little active listening and see where the conversation leads. Let them vent and get it all out. You may find some valuable information comes to light as you actively listen to their airing of grievances.