Clinical Research Career

As clinical research professionals, we often hear about GCP, HIPAA, compliance, monitoring, Code of Federal Regulations (CFR), so on and so forth.

When trying to secure that next promotion, we often focus on our clinical research skills: the ability to enroll a trial fast, locking that trial database on schedule or passing the FDA audit.

Rarely we take a step back and think about soft skills. Today soft skills are more important than ever. It would be too dangerous to ignore them.

In this post, I’ll share my top 25 favorite soft skills in a clinical research context. You can leverage these soft skills in all areas of your life as well.

So let’s get started:

1. Adaptability to changing requirements

Globalization and harmonization continue to change the clinical research landscape. For example, in the medical device world, the most talked about changes are European Medical Device Directive (MDD). There is a lot of buzz on this topic (and complaining too).

Last year I attended a one day roadshow hosted by BSI Group. The presenter asked people to raise their hands if they had read the draft MDD. Less than 5 people in a room of 100+ attendees raised their hands. This goes to show how underprepared the audience was. Very few people had invested the time to understand the proposed changes to the MDD. Yet most of us we anxious about how the change was going to impact our work.

The question you must ask yourself “how will I adapt to these changes?” Change is not limited to government regulations. You’ll experience unanticipated changes in your department, your role, or on your project. Take some quiet time to understand change and then adapt.

Change is always hard because it forces us to break our old habits and form new habits.

2. Authenticity and consistent behavior

Being authentic and consistent is hard work.

For example, if you are CRA responsible for on-site monitoring, you probably expect the research coordinator to respond to your emails, answer open queries and complete data entry in a timely manner. When you visit the site, you want the research coordinator to welcome you with a smile.

However as a CRA, you are equally responsible for authentic and consistent behavior. As CRA you need to show up on time for the monitoring visit, send out monitoring follow-up letters within a few days of your visit (not weeks or months), and answer research coordinator questions with great accuracy and a smile.

Many of us fail to see the other side of the equation, especially when we feel we are in charge of the situation. Being authentic and consistent is hardest when no one is watching us.

3. Coach-ability and the desire to coach others

When I was a CRA, I remember my project manager required our team to cross train each other. At that time, I thought cross-training was a waste of time. Obviously the project manager wanted team members to be cross-trained, should someone decide to quit their job.

But aside from this obvious reason for coaching others, there are many other benefits. If you take the time to teach someone how to use the excel spreadsheet you’ve created or explain the clinical jargon in the protocol, they’ll always remember you for helping them succeed. This in turn creates a lot of goodwill and karma.

4. Collaborative mindset

You may have heard a coworker say, “He is very territorial.” Rather than being afraid of others eating our share of the pie, we must develop an abundance mindset. The more willing you are to collaborate with our fellow colleagues, the more respect you’ll earn. This in turn will create opportunities for you and others.

Clinical trials requires cross-functional expertise to succeed. Every person involved in the clinical trial has a role to play. Learn to collaborate with an open and curious mind.

5. Conscientiousness in keeping promises

When was the last time you or someone you know, made a promise and couldn’t keep it? I bet you can think of at least one situation in the recent past.

As clinical research professionals, we’re constantly bombarded with requests from sites, sponsors or our management. We generally agree to everything that gets sent our way. It’s hard to say “No”, especially to someone who we wish to please.

But what’s worse is that you get overwhelmed and can’t keep your promises. This leaves a bad impression with the other person.

Before you make your next promise, think about everything you have going on personally and professionally. You can always ask for time to think about the request before making a commitment.

6. Customer service passion

Whether you work at a clinical site, sponsor, clinical research organization (CRO) or the government, providing exceptional customer service to internal and external stakeholders can go a long way in building strong and positive working relationships.

Let’s use CRO-sponsor relationship as an example. The CRO works for the sponsor. It’s expected that the CRO provides excellent customer service to the sponsor. How about the sponsor providing excellent customer service to the CRO as well?

Sponsors can help CROs be successful at their job by documenting clear expectations, addressing areas of ambiguity and being transparent.

When I’m frustrated with customer service, I say to myself, “They are trying to do their very best.” This immediately puts me in a mindset of acceptance and empathy.

7. Eagerness to learn from criticism

Whether you work at an organization or run your own clinical research business, you can’t escape from criticism. There will always be someone who is going to be unhappy with you. Rather than reacting to the criticism, you must welcome it with both hands and learn from it.

Sites criticize sponsors for creating a complex clinical protocols, sponsors criticize regulatory agencies for not accepting their clinical strategy, and a CRO criticizes sponsors for being too demanding at all times.

Spend the time to understand the root cause for such criticism. It might be worth having discussions in a team environment to dissect the cause and how you can learn and improve in the future.

8. Enthusiasm for the work

Yawning is contagious. So is enthusiasm. If you’re enthusiastic for the work, you’ll get others excited too. Your output at work will be much better too.

Bored to read that Standard Operating Procedure? Or don’t want to write that clinical study report? Well, the good news is that everyone experiences dull moments. Enthusiasm is what keeps us going.

9. Ethics even when not under scrutiny

Clinical research and ethics are two sides of the same coin. For example, you don’t want to to take shortcuts by not following procedures. The impact of your decision to take shortcuts can result in a serious audit finding years later.

10. Managing difficult conversations

Difficult conversations can be emotionally exhausting. I remember several difficult conversations I’ve had over the years, particularly with employees who were a misfit for the organization.

If you’re a people manager, you need to learn the art of having difficult conversations with your team. If there are performance concerns, don’t wait till that next annual review. Be proactive and provide ongoing feedback – good and bad. People appreciate knowing where they stand.

11. Motivated to take on new challenges

Sooner or later you’ll asked to take on new challenges,asked to do things that make you uncomfortable. Some challenges are more direct and others are subtle. For example, if you are a clinical research assistant, you may be notice that the team needs help with some higher level work to meet a timeline. Put yourself out there and make it known that you are willing to take on new challenges.

Remember that there may not be any immediate financial benefits to you. However it is certain that you’ll grow personally and professionally as a result of taking on the new challenge.

12. Self awareness

If there is one soft skill you must master on this list, it’s self awareness. As clinical research professionals, we’re constantly interacting with various stakeholders. Before reacting to any situation, you want to be in full control of yourself by being self-aware.

For example, if you are choosing to take a tough stance on an issue, be sure to understand the “why” behind your decision. Don’t be tough for the sake of being tough. Put yourself in the other person’s shoes before you call the shots.

13. Sense of humor

A few years ago, I remember a conversation between a Clinical Vice President (VP) and a well-respected clinician. The clinician wanted to design a very large sample size study. But there was no scientific or statistical reasoning behind the clinician’s proposal. The VP was quick to comment, “I’ve never heard you be so unscientific in all the years we’ve worked together” The VP’s comment broke everyone into laughter, making it easier to have the much harder conversation of reducing the sample size.

Clinical research is a regulated industry. We’re always talking about compliance, patient safety and good clinical practice. A sense of humor can put you and your colleagues at ease and not take everything so seriously.

14. Diligence and attention to detail

Paying attention to details is exceptionally important. Some people, intentionally or unintentionally, just don’t pay attention to details.

For example, if you are planning an investigator meeting, you need to understand pay attention to meeting logistics and content. Why? Because you’re inviting physicians and research coordinators to spend anywhere between 2-16 hours on your project. If you expect them to the attentive during your presentations, the meeting flow needs to be top notch with every single detail mapped out.

Another area where attention to details is necessary is medical writing. Writing clinical reports is not an easy task. Combined that with paying attention to document formatting and grammar can be daunting. If you are not good with formatting documents, learn to master the skill or outsource the work.

15. Facilitation of discussion

We’ve all been through painful meetings. People give boring “updates” on a project or simply digress on the least important topic on the agenda.

Facilitating an effective discussion by asking the right questions will help you long way. When holding meetings, you need think about the purpose of your meeting and focus on achieving that purpose. If the purpose is to provide updates, more often than not, it can be achieved through a well crafted update summary. People can read the summary at a time that works best for them.

16. Listening skills

A few years back, my manager at the time gave a four bullet feedback. One of the bullets read, “Talk Less, Listen More.” As humans, we love to talk. But if you can master the art of listening, you’ll start to understand what really matters to the person you are communicating with. Once you know what matters, you can tailor your response to address that person’s question or concern.

We’ve all been on a few teleconference calls where people are talking over each other. Let’s not do that.

17. Managing up

When you land with your first job, no one tells us that you need to learn how to “manage up.” You may be putting in a ton of hours at work. Yet your manager may be disappointed with your performance.

Seldom do managers want to give their employees a hard time. Infact it’s in the best interest of the manager to keep an employee happy at work. Learning to manage up, gives you the ability to get in sync with your manager.

For example, a site investigator may expect the research coordinator to lead a dozen clinical studies. The coordinator single handedly can’t possibly manage such a heavy workload without burning out. But the coordinator can track how long it is taking her to perform her tasks. She can share this data with the investigator to discuss potential options to make her workload more manageable.

When you are managing up, don’t be defensive. Instead explain the issue you are facing in calm and objective manner, backed by real data.

18. Planning for projects

Planning for projects shouldn’t be left to the project manager. Although it’s nice if the project manager did all the project planning for us. As a clinical researcher, you’re likely have your own projects or deliverables.

For example, a clinical quality manager may be responsible for developing or updating standard operating procedures. She would need to allocate focused time to update procedures, schedule time with other team members to get their input t on the procedure changes, read FDA guidance documents to understand the regulatory landscape and more.

Planning for projects can be boring because you’re tempted to spend that extra time on doing the work itself and planning seems like a huge waste of time. However when you actually sit down and write your plan on paper, it helps bring clarity to your mind and work.

19. Technology savvy

I love technology. It helps us do our work faster and better. I won’t argue with you if you told me technology also leads to issues that can take a long time to fix. But overall, we are net positive with technology.

As an clinical research industry, we should leverage technology to make research more interesting and engaging. Being tech savvy doesn’t end once you learn how to use Microsoft Word, Excel, PowerPoint or Electronic Data Capture (EDC) systems.

For example, sponsors can use email software such as Marketo to send out well-designed clinical trial newsletters to research sites rather sending an email with a PDF attachment that very few people bother to open.

Other ideas include the use of electronic informed consent solutions (eICF), transfer imaging data online rather than via courier services or using social media to recruit patients.

20. Conflict resolution instincts

We’re prone to conflicts because each one of us has a unique worldview. This leads to disagreements. Developing conflict resolution instincts can take years of practice. One strategy I’ve found particularly useful is putting myself in the other person’s shoes.

For example, let’s assume you and your colleague are disagreeing on the clinical protocol design. It would be wise for you to take the time to understand your colleagues concerns. Discuss or think through the concerns one-by-one and be creative about mutually resolving disagreements.

Ultimately a few concerns will need to be elevated to senior leadership. But atleast you and your colleague would have vetted out most issues before escalating to the next level.

21. Creativity in the face of challenges

It is quite common to face challenges when conducting research.

It’s taking months to negotiate a clinical trial contract, the CRO is not meeting sponsor expectations, patient recruitment is significantly slow and an audit led to major findings are some common challenges.

Rather than reacting to these challenges, it’s important to take a step back and brainstorm all potential solutions to the challenge at hand. In order to come up with creative solutions, you need to have an open and curious mind.

22. Dealing with difficult people

There are many ways to deal with difficult people. You approach will vary depending on whether the difficult person you are dealing with is your subordinate, supervisor or colleague.

My only suggestion when it comes to dealing with difficult individuals is that you conserve your finite amount of energy. If you drain your energy in trying to correct other people, you’ll distract yourself from fulfilling your own dreams and doing work that actually matters.

23. Diplomacy in difficult situations

The author Maya Angelou once said, “I’ve learned that people will forget what you said, people will forget what you did, but people will never forget how you made them feel”.

When you find yourself in difficult situations, don’t say things that will hurt the other person or make the feel bad about themselves.

I also find myself using silence as a way to gather my thoughts before speaking my mind in difficult situations.

24. Storytelling

You may feel that storytelling does not apply to clinical research. But actually take a minute now to think about any talk or presentation you thoroughly enjoyed. I bet the speaker was harnessing the power of storytelling.

Humans love stories. Therefore the next time you are invited to present at an investigator meeting or a site initiation visit, practice storytelling. Don’t read the slides verbatim because no one will remember you or what you said.

25. Empathy for customers, co-workers and vendors

Being able to understand the feelings of our customers, coworkers and vendors makes us more approachable. People will want to connect with you if you care about them. Showing empathy is not a sign of weakness but rather of strength and maturity.

For example, assume you are a CRA out at a site for a monitoring visit. If the research coordinator is stressed about missing patient records, you can express empathy by acknowledging the coordinator’s efforts in trying to find the missing records. The missing records won’t magically appear. However the coordinator will recognize the fact that you are able to understand her plight.

Summary:

We’ve covered 25 foundational soft skills that will serve well in your clinical research career. In order to put these skills to practice, pick just one soft skill and practice it for 30 days. Then see what magic is does for you. At the end of 30-days, spend 30 minutes reflecting what worked well and what didn’t. Then move onto the next skill of your choice. Within a year, you would have mastered 12 soft skills.That’s lot!

Let me know if which soft skill you’re planning to put into practice next and why? I’d love to hear your thoughts, ideas and suggestions in the comments sections below.

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