How CRAs Can Develop Better Relationships With CRCs

By Justin Patri, MS, CCRA, CCRP, president and founder, Flyover Clinical, LLC

During the pandemic, the FDA recommended that sponsors use central and remote monitoring to maintain clinical study oversight.¹ The guidance is intended to remain in effect until Nov. 7, 2023; however, the industry is unlikely to ever completely revert to on-site monitoring. Knowing that and seeing how changes to the monitoring paradigm have stressed relationships between clinical research coordinators (CRCs) and clinical research associates (CRAs), it’s time to examine this crucial, if at times unstable, relationship and consider ideas on how it can be improved with clear communication expectations, thoughtful requests, and kindness.

Long Distance Afflicts The CRA–CRC Relationship

Historically, an upcoming on-site monitor visit would typically create stress and anxiety among research site staff. Upon arrival, the CRA would meticulously comb through data, seemingly picking out every minute error and mistake, as if their sole purpose was to criticize the CRC and the data documentation process. Thankfully, the CRA would be on-site for only a couple of days, then send a follow-up email, thus allowing life at the site to return to normal.

Yet this typical experience has changed significantly with the advent of remote monitoring. Now, instead of consolidating study materials in a specific place at a planned time for a scheduled on-site visit, the CRC must be ready to deliver at a moment’s notice. Each study now feels like a never-ending monitor visit. Given the studies’ digital nature, documentation requests often come from not only the CRA but also the trial, project, and data managers. These requests come at random times without warning, potentially putting unnecessary stress on already overworked CRCs and short-staffed research sites. Thankfully, this can be mitigated with a few simple changes to communication practices.

“Clear is kind. Unclear is unkind.” — Brené Brown

In a 2016 ComPsych survey, 31 percent of the more than 2,000 respondents stated the most stressful change at work was due to unclear expectations.² Unclear tasks can be perceived as unpleasant or unenjoyable as they often require greater cognitive effort to plan, organize, and execute. Because of their murkiness, these tasks are often put off in a type of procrastination classified as task aversiveness.³  

The key to mitigating the risk of task aversiveness is effective communication. Clear, concise, and succinct communication conveying the specific needs and expectations from the requestor greatly reduces the cognitive effort and, often, the time required to execute a certain task. Often, it is too easy to send an email every time a question comes to mind. The recipient is then consumed by a deluge of emails with scattered requests for information and a frustrating, complicated path toward organizing and prioritizing a plan for completion.

Fewer things can wreck a great plan better than unanticipated issues. Many parents have had a well-planned day go completely awry with the school or daycare calling about a sick child. An unexpected request to a research site is no different. Each time a request comes in, the default action for the site coordinator is to shift priorities, change gears, and gather the information needed to fulfill the unexpected request. The following tips can help alleviate some of the issues resulting from unclear communication, and hopefully lead to a more collegial relationship between the CRA and the CRC.

1.  Collect thoughts and combine issues in one email.

Instead of sending an email every time a thought comes to mind, collect these thoughts on a sticky note or with another reminder tool that you can keep close at hand. In his book, Getting Things Done, author David Allen suggests writing tasks on 3x5 notecards.⁴ The physicality of being able to “grab” the thought or task makes each one seem like an object as opposed to an item on a list. It is also more convenient to keep a notecard ready and visible (i.e., in the pocket of a laptop bag), as opposed to keeping a list in a notebook that may need to be relocated many times throughout the day. This technique can be modified for tracking thoughts throughout the day. To take it one step further, color-coded cards make things a bit more engaging, with a color dedicated to each study and/or site. Plan to keep the cards nearby so that thoughts can be added throughout the day or week. At the end of a certain time (no more than one week), assemble these thoughts into an email and send it to the site coordinator with a desired response time.

2.  Establish a communication cadence.

At the onset of site start-up, work with the coordinator to establish a communication cadence. This can put the coordinator at ease as they now know they should not be receiving random communications from the CRA. While the cadence is important, so is frequent communication as it helps keep the study on the mind of a busy CRC. Minimizing interruptions will allow the CRC to focus on singular tasks and be more organized. A 2018 article in Entrepreneur cited a study finding that 23 minutes is needed to refocus after each interruption while completing a task. Putting this into a different perspective, if three separate emails are sent with questions, almost 1.5 hours of the recipient’s time would be spent trying to refocus.  This is opposed to only about 20 minutes of time being needed to refocus if all thoughts are collectively sent in one email.⁵

A communication cadence should probably not exceed one message per week. I’d suggest the ideal day for sending communication is a Tuesday, since it avoids being lost in  the crowded Monday morning inbox. Email servers also allow senders to delay sending emails until a desired time. Even if you write an email at an inopportune time (like a weekend), you can schedule the email to be sent at a time determined by you. This is an often underutilized but very useful tool.

3.  Set — and share — response times for different communications.

Setting a cadence for sending consolidated thoughts and questions works great for maintenance and oversight when things are quiet and running smoothly. But what happens if the site runs into an urgent issue? The CRC can usually call the CRA, but they might be on a monitoring trip or traveling. Should the CRC send an email? These situations can greatly benefit from setting clear contingency plans.

For urgent messages, CRCs should use text messages for expedient (< 15 minutes) messaging to reach CRAs. If it is more urgent than that, which is very rare, then the text may need to be preceded with an all-caps callout, like “URGENT.” For issues that need a same-day response, the site and the CRA may want to rely on calls and voice mails. The latter allows the site to leave detailed information with a CRA, who  may be traveling, and allow a CRA to provide information to a CRC, who may be with a patient. Lastly, the method of least urgency is email, which should be responded to within 24 hours.

When a CRA is traveling or conducting an interview, they should provide an alternate contact, usually the clinical trial manager (CTM), for urgent matters when the CRA cannot be reached. An alternate contact should be provided in an auto-response email when the CRA is out of office (i.e., on vacation or sick). This alternative contact information should also be added to a voicemail message so a site does not waste valuable time waiting for a response that may not be coming.

4. Appreciate and acknowledge one another’s work.

Even when it’s tough, remain positive. Shawn Achor, an expert in the emerging field of positive psychology, advocates for using the Lozada Line, a positive-to-negative comment or interaction ratio that can improve work performance and relationships. Psychologist and business consultant Marcial Losada found this ratio to be about 3:1, with three positive comments balancing out one negative one, but more recent studies have indicated the ratio to be as much as 6:1.⁶

The best way to reach this 6:1 ratio is  by sincerely letting the CRCs know their time and efforts are valued. A lot of effort and coordination goes into organizing documents, scheduling appointments, and responding to urgent queries. Lynn Sadowski, a senior CRA when she wrote a blog on this same topic, provided an excellent scenario: “Consider how nice it would be if someone came into your office and said, ‘I know how busy you are and how valuable your time is, and I just wanted to say that I really appreciate the time that you took to…’.”⁷

Another way to recognize coordinators is by sending their praise to the principal investigator (PI) and/or the coordinator’s supervisory chain. These compliments can, of course, be relayed to the PI verbally, but the great efforts from the study team also can be documented in the follow-up communication.

Living By “The Golden Rule”

In the clinical research environment of today, it is easy for coordinators and CRAs to become bogged down in rapid-fire emails sent whenever a thought or question comes to mind. This can create unnecessary stress and harm the CRA-CRC relationship. This, in turn, can put the success of a study in jeopardy as issues may not be addressed in a timely manner.

Almost every culture in the world has a form of the Golden Rule, which essentially says, “Treat others as you want to be treated.”  This also applies to clinical research and relationship building, especially when positive communications and interactions can be developed with the Lozada Line in mind. Mutual respect, empathy, and appreciation can pay huge dividends toward building relationships between CRAs and CRCs, which will ultimately keep a clinical trial moving forward efficiently.

References:

1. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID‐19 Public Health Emergency, www.fda.gov/media/136238/download?_hsenc=p2ANqtz-8wrVH4GRuAOkD6UY4O_iiJxvFA3RK60mnfs1SgvIND--uMa-y2nF8fr6vcWdLHFSeu_pfO. Accessed 9 June 2023.
2. “Compsych Report Reveals Generational Differences in Employee Stressors.” Business Wire, 31 Oct. 2016, www.businesswire.com/news/home/20161031005695/en/ComPsych-Report-Reveals-Generational-Differences-in-Employee-Stressors.
3. Blunt, A.K., et al. “Task Aversiveness and Procrastination: A Multi-Dimensional Approach to Task Aversiveness across Stages of Personal Projects.” Personality and Individual Differences, 27 Sept. 1999, www.sciencedirect.com/science/article/abs/pii/S0191886999000914.
4. Allen, David. Getting Things Done: The Art of Stress-Free Productivity. Piatkus, 2019.
5. Entrepreneur (2018). Distractions Are Hurting You More Than You Realize: Here's Why [online]. Available here. [Accessed June 2023.]
6. Achor, Shawn. The Happiness Advantage: The Seven Principles of Positive Psychology That Fuel Success and Performance at Work. Currency, 2013.
7. Sadowski, Lynn. “Building and Maintaining Monitor-Coordinator Relationships.” Applied Clinical Trials Online, 31 Aug. 2002, www.appliedclinicaltrialsonline.com/view/building-and-maintaining-monitor-coordinator-relationships.

About The Author:

Justin Patri has been in the pharma and medical device industry for almost 20 years. Following high school, he served in the U.S. Army. He holds a bachelor’s degree in biomedical science and a Master of Science in Applied Clinical Research from St. Cloud State University. Justin also holds both CCRP and CCRA certifications from the Society of Clinical Research Associates (SOCRA) and Association of Clinical Research Professionals (ACRP), respectively. He has worked with numerous animal models and many clinical trials across a wide scope of therapeutic areas.