A New Approach to Assess and Manage Study Coordinator Workload

Suzanne Rose, MS, PhD, Executive Director of Research, Stamford Hospital

Historically, the vital task of assigning study coordinators to clinical trials has relied on a research leader’s experience and intuition. The realities of today’s challenging studies—with increasing complexity and tightening budgets—demand an accurate assessment of the level of support required for each trial. This is an essential step in maintaining quality while avoiding staff burnout.

“My journey toward creating a new tool started a dozen or so years ago, when I realized that a scientific approach existed for oncology studies but not for other therapeutic areas,” says Suzanne Rose, MS, PhD, Executive Director of Research at Stamford Hospital. “We needed to know how many studies and patients a single research coordinator could feasibly manage. There was also a need to benchmark study coordinators to see what an ideal monthly workload would look like.”

These goals have been achieved with a modification of the Opal tool. Traditionally, this has been used for oncology trials, where coordinators typically work on more studies than in other diseases, since many trials are mutation-specific with very low enrollment rates and long follow-up.

“We have successfully adapted the Opal tool for non-oncology research,” states Rose. “Known as the clinical research workload tool (CRWT), our new version is based in Excel, taking account of the study type, phase, protocol-related workload, and other details. Protocols are ranked from one to eight, with one being a simple non-drug or device study, and eight being any type of Phase I trial for a drug or premarket device. The number of patients involved is not taken into account, since many tasks must be carried out regardless of patient involvement—such as institutional review board submissions and creation of source documents. Once patients are enrolled, the score of the study increases.”

The CRWT is a highly flexible tool, suitable for all therapeutic categories, and allowing for continuity of care among coordinators for their study participants, while justifying the use of new and existing employees for research programs. The tool—which can be used at community hospitals, academic medical centers, and independent research sites—has recently been adopted by the National Institutes of Health’s National Heart, Blood, and Lung Institute.

Assessing and Managing Study Coordinator Workload

Join Suzanne at ACRP 2025 [April 24-27; New Orleans, La.], where she explores the current state of available clinical research workload tools and compares several similar adaptations of a specific tool for tracking productivity at various types of research programs. View complete schedule.

“To date, we’ve shared the CRWT with more than 100 sites,” notes Rose. “I’d love to put the tool into cloud-based software or onto platforms that are easy for others to access. This would enable us all to benchmark our productivity against that of similar organizations, which would be very helpful.”

“Overall, our tool avoids overburdening study coordinators, ensuring they are assigned a manageable number of studies,” concludes Rose. “This supports increased study enrollment, enables justification of additional research funding for the site, results in better efficiency and quality of work, and supports retention of coordinators by increasing job satisfaction.”

Edited by Jill Dawson