Recently, we explored some ideas regarding the importance of enhancing our basic communication and soft skills to improve our relationships and reduce turnover in our organizations at a management level within a sponsor or contract research organization. Today, I would like to discuss how those soft skills can be utilized in enhancing relationships between clinical research associates (CRAs) and sites, as they can often be challenging.
Consider the following job description, and if it would be something you might be interested in, or perhaps pass on due to its ambiguous and challenging nature.
For this position, you will be asked to travel extensively, go to multiple locations where you will be in someone else’s environment and have no authority over the people you work with; but will be held accountable for their performance and responsiveness. You will be expected to identify each and every possible error or mistake they make, but cannot directly tell them to correct it. You will need to politely “query” the information and hope they address it in a clear, comprehensive, concise, and timely fashion without directly writing down exactly what you are expecting them to do. You will be held accountable for ensuring they do this completely and within specified timeframes. Then you will do it again, somewhere else with different people, the next day.
This is essentially what we expect CRAs to be able to do, all the while chanting that this vague job description is critical in supporting patient safety and the integrity of the data. If you work at a site, put yourself in the CRAs’ shoes and try to make some time for them to meet their objectives. If you are a CRA who’s expecting the site to make time for you, and to accomplish and address the carefully written queries you have laid out, it takes more than expectations and “just because” to get the job done right.
It comes down to communication and the building of relationships. If you are entering someone else’s territory and expecting them to do things for you when they are busy, how you ask is important. Sending an e-mail two days before a visit confirming the laundry list of items is not going to work. Even sending it two weeks or a month in advance—without any follow-up conversation—is not going to support a smooth and productive visit.
Consider the perspective of the site’s staff—you are “out of sight, out of mind” and they have other responsibilities than your study before you show up, so maybe they will wait until you get there. So what is the solution? Set expectations from the beginning (the very beginning), such as the site selection visit and the initiation visit. Ask the site staff how they prepare for monitoring visits and what they expect from a monitor. Open up a dialogue and establish this as partnership where both parties can equally contribute to expectations and preferences in how things should get done.
The other thing we are very guilty of doing across the industry is using too many acronyms and not providing clarification and context. According to the International Association of Business Communications, “only 21% of communicators keep their language jargon-free.” For example, if someone can really understand how important collection of all adverse events is—that it can lead to the information we find on package inserts when dosing our children, our elderly parent, or ourselves with a medication—maybe it will make a difference in how he or she queries a patient to collect the information.
Consider if you would be more motivated to collect information if someone said, “We have DB lock for Phase III go/no-go decision on 6/3, we need all AEs, SAEs, and AESIs queries to be closed.” Huh? What are you supposed to do with that information if no one explained DB is database; that a Phase III trial would be an exciting undertaking by potentially bringing a product one step closer to market to people who need treatment; and that the adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI) are all under close scrutiny by a team of experts to determine if the product in question is safe in terms of benefit vs. risk?
Given a more extensive explanation, would you be more likely to make time to support the request? The International Association of Business Communications article goes on to say that high-performing organizations were “60% more likely to think about communication from the audience perspective” and “twice as likely to make emotional connections to their audiences.”
One of the foremost thought leaders on adult learning theory, Malcolm Knowles, tells us that adults need to understand why something is important in order to learn it. In this case, if we can communicate to support understanding, we are more likely to see all parties working together to achieve the goal.
In summary, we need to:
- Communicate clearly and completely, not just through e-mail, but through conversations to share ownership of the information and approach
- Avoid using too much “jargon”
- Explain the “why” behind what is being asked
- Strive to make an emotional connection with the people involved in shared work
Those of us in clinical research are passionate about what we do. Whether our goal is to work directly with patients and help them through their disease challenges, or to work indirectly in developing new treatments to help current and future patients, our goal is the same—to help people. We need to communicate more clearly and thoughtfully in this process, as we are all on the same team.
Author: Guest Blogger Nikki Christison, CCRA, TIACR, President, Clinical Resolutions, Inc.