Research groups — whether at a university, company, or government agency — rely on people with a very crucial role: The research coordinator. Also called the study coordinator, research specialist, or trial manager, this person is responsible for making sure clinical trials are conducted according to quality and safety standards under the auspices of a principal investigator, or PI. The typical coordinator has a bachelor’s degree and manages anywhere from one to a multitude of studies or projects at once. Responsibilities vary but generally include study protocol development, recruitment of volunteers, budgeting, billing, data management, banking of biospecimens, and regulatory duties, among others.
Despite the research coordinator’s central position within a group, the role is often broad and poorly defined, and its contributions underrecognized. Often seen as a temporary role or a bridge to graduate school, coordinators suffer a high prevalence of burnout and turnover, with direct implications to ongoing studies as well as costs to institutions to retain, recruit, and train personnel.
Constant staff changes in coordinators on the study level can delay a life-changing drug or device from coming onto the market. If patients or their loved ones knew this, they might begin advocating for institutions to provide coordinators with the resources needed and retain them.
“This position is absolutely critical to any successful research project, yet somehow there has been no serious attempt to standardize training or give the position the recognition (and salary!) it deserves,” Fabien Maldonado, a professor of medicine and thoracic surgery at Vanderbilt University Medical Center, wrote in an email.
It’s a longstanding problem that remains unsolved. It’s especially acute in academia, which loses coordinators to industry for higher salaries, opportunities for growth, and work-life balance.
In a recent study, Maldonado, Robert Lentz, and I examined perceptions of the role among research coordinators and investigators and suggested the need for standardization. The study consisted of an online survey distributed to the American Association for Bronchology and Interventional Pulmonology members and their coordinators to assess participant beliefs.
As we described in our paper, we saw notable differences in perceptions of training, responsibilities, and recognition of the coordinator role. The components reinforcing these perception differences may contribute significantly to retention of coordinators and team dynamics.
There was a clear gap around training. Investigators reported directly training their coordinators less than half the time, and 20 percent did not know how their coordinators were trained. Coordinators reported being trained by their senior colleagues and doing online or self-directed training at higher rates than investigators perceived. Although fine for learning the basics, these types of training can be suboptimal because a senior research coordinator may not be working on the same study, and the online and self-training may not be enough to prepare the coordinator to run a specific study they were assigned.
We were alarmed by discrepancies we saw between the coordinator and investigator perceptions of matters related to value and retention. These differences may contribute to coordinator burnout, turnover, and the perception of the role as transient rather than permanent.
Like any study, it has its limitations, but we believe it could spur future studies on this topic from other specialties of medicine, public health, and science.
Potential measures could help standardize the role. In our paper, we propose the creation of a national and international task force consisting of investigators, coordinators, and research administrators to explore standardization of training as well as recognize and support the broad array of coordinator responsibilities. The few task forces that I’m aware of exist within their respective institutions. Every institute operates differently in terms of what the coordinator role entails — and will continue to operate in that way — if there’s no universal standardization.
A task force could also delineate methods in which coordinators might be more recognized for their central contributions to research efforts. For example, recognition can be shown through manuscript authorship or awards.
“I felt like I did a lot of the work, but I wasn’t recognized for it when it came down to writing the articles. I wasn’t able to be a part of that,” said DeAndra Clark, a senior project manager at UnitedHealth Group, reflecting on a previous job as a coordinator at another organization. “However, I did 89 to 99 percent of the data collection. I had the hands-on experience with the patients, but I wasn’t a part being able to at least even have my name on publications when it came down to writing the results and outcome of the study.”
Last but not least, the task force should address wages.
I’d also recommend employers being honest with the coordinator responsibilities during the hiring process. I can’t tell you how many times I’ve heard coordinators say they left their institution or research in general because the role was not as described during the interview.
If a specific lab or group within an institution can afford multiple coordinators, it may be wise to hire ones that specialize in specific areas of research, so that duties can be appropriately distributed between coordinators, giving them time to adequately complete their tasks.
National and international academic meetings would be ideal venues for discussing coordinator integration and best practices. Coordinators could also consider pursuing training and certification through The Society of Clinical Research Associates or The Association of Clinical Research Professionals.
We also need solutions to keep coordinators who want to stay once a project ends. My colleagues and I have seen that when a project starts to end, the company typically lets the coordinator know that the job is ending, too.
“It’s not only the coordinator that’s leaving out of these roles, but it’s coordinators that’s being pushed out of these roles because there is no other study, or because they have delivered and got what they need for that particular research,” Clark said.
When well structured, the research coordinator role can be a great and rewarding job. There are many traits and skills I learned as a coordinator that have translated to other aspects of my career such as project management, budgeting, and engagement. I’ve met, befriended, collaborated with, and learned from numerous brilliant minds who have helped me become a better researcher, scientist, and health advocate.
Research coordinators are one of the many unsung heroes who are responsible for many of the things we have today. Prescription drugs, nutritional supplements, and medical devices all had to go through various tests to make sure that they were safe for human use, and research coordinators helped conduct those studies. With all the work they do, let’s make it a little easier for them by standardizing the role.
Lance Roller II is a population/public health manager at Vanderbilt University Medical Center and a data analyst. He was a fellow in Journalism and Health Impact at the Dalla Lana School for Public Health.
“recognition can be shown through manuscript authorship”
actually, no, that would be gift authorship and it is not ethical, data collection is not enough for authorship, it warrants just acknowledgement; for example, the technicians are also not given such gift authorship although they collect essential data, and interact with study participants, the CRCs and the techs are professionals that acquire data, prepare spreadsheets but do not have the knowledge to process, analyze or interpret the data