Has the Study Coordinator Landscape Reached a Tipping Point?

Ken Getz
Director, Sponsored Research Programs and Research Associate Professor, CSDD, Tufts University School of Medicine
June 7th, 2018

The study coordinator workforce has seen its workload and responsibilities increase dramatically during the past several years while salary levels have remained flat when adjusted for inflation. Yet, despite the higher workload, the turnover rate among clinical research coordinators (CRC) has dropped far below historical levels during the past decade.

Given these mixed dynamics, sponsors, CROs, principal investigators and site directors need to proactively monitor and manage this currently stable work force to ensure that experienced and motivated capacity remain in place and productive as global clinical trial activity and workload continues to rise.

A 2012 survey conducted by CenterWatch among 269 study coordinators worldwide finds that workload—as measured by the number of clinical trials actively managed by each CRC—increased 7% annually over 10 years. The median number of studies managed by a study coordinator on an annual basis jumped from 4.3 in 2001 to 7 in 2011 and—based on anecdotal reports from sites—is expected to be even higher in 2012. The typical coordinator personally oversees an average of 80 patients on an annual basis.

A 2012 survey conducted by CenterWatch among 269 study coordinators worldwide finds that workload — as measured by the number of clinical trials actively managed by each CRC — increased 7% annually over 10 years.

Study coordinators report spending the greatest proportion of their time on administering study protocol requirements. Other top areas of time commitment include collecting and maintaining clinical data, overseeing patient recruitment and retention activity, ensuring GCP-ICH compliance, maintaining quality assurance, serving as the primary contact with sponsors, CROs and regulatory authorities, reporting adverse events and managing queries.

In addition to increased workload, study coordinators report that the typical clinical trial has become far more complicated and demanding. Regulatory requirements—particularly paperwork associated with GCP-ICH compliance—have intensified. Study coordinators note that documentation and other tasks formerly completed by study monitors have been relegated to study coordinators and other site staff. Protocol complexity has increased the amount of administrative work and made it more difficult to recruit patients. CRCs also report that sponsors have added an increasing amount of training to familiarize coordinators with new assessments, procedures and IT systems. CRCs also note than when other staff positions have been eliminated at the site, CRCs are required to take over these tasks including marketing, business development and managing financial matters.

Join us for our upcoming webinar to hear our expert presenter discuss her tool for assessing staff workload, allocating study resources and reducing the potential for staff turnover. Register today!

While workload has grown substantially, salary levels have remained flat—when adjusted for inflation—during the past decade. Nearly eight-out-of-ten (78%) CRCs believe that their salaries are no longer commensurate with the amount of work they perform. A third of CRCs believe that higher workload demands impact their ability to complete tasks and do their job well.

Nearly eight-out-of-ten (78%) CRCs believe that their salaries are no longer commensurate with the amount of work they perform.

Although salary levels are misaligned with workload, turnover rates among CRCs are the lowest they’ve been in a long time. In 2002, 56% of study coordinators had been in their positions for less than three years; this year, almost half of survey respondents had been in their current job for at least seven years. A total of 72% of respondents have been in their current positions for at least four years; in 2002, only 44% of study coordinators stayed in their positions for more than four years.

Study coordinators are staying in their jobs longer, in part, because the economy has made it difficult to change jobs. Yet the study results also suggest that longevity has improved for the simple reason that a high proportion of study monitors like their job. In particular, study coordinators enjoy working with patients and find it gratifying to participate in studies of investigational treatments. CRCs also enjoy the collegial site culture.

Principal investigators and site directors recognize and appreciate that experienced study coordinators can be a competitive advantage. Although investigative sites report that they cannot increase CRC salaries because of budget constraints, successful sites find other ways to make their study coordinators feel valued and to make the job meaningful for them. About 70% of sites typically pay for at least part of the cost of continuing education credits for their study coordinators. Other sites look to ease CRC workload by having administrative staff help with data entry, regulatory responsibilities or scheduling patients.

In the 2012 CenterWatch study, however, nearly a quarter of study coordinators feel that they lack opportunities for upward mobility at their site. The vast majority—92%—of study coordinators report that they want to advance their careers and, as the economy improves, many report being open to new opportunities. Most sought after career aspirations include becoming a study monitor (26%), a project manager at a CRO or sponsor company (16%) or a site manager (16%).

The vast majority—92%—of study coordinators report that they want to advance their careers and, as the economy improves, many report being open to new opportunities.

Simplifying protocol designs—a responsibility that rests with the sponsor—would go far in providing relief for site personnel, especially study coordinators. Study coordinators frequently ask to provide feedback on study feasibility early in the process and provide logistical input before a study begins Many sponsors are now reviewing their protocol design practices to identify improvement opportunities that will both ease execution burden and improve study efficiency and speed.

At the moment, the study coordinator workforce remains stable. Yet sponsors, CROs and investigative site management face significant challenges if experienced and productive study coordinators, exhausted by an ever-increasing workload, begin to exit their sites in order to earn higher salaries and advance their careers. The CRC operating environment is reaching a tipping point and must be monitored and managed proactively. 

Learn more

Join us for our free, upcoming webinar to hear industry expert, Dr. Suzanne Rose from Stamford Hospital, discuss the tool she developed to assess staff workload, allocate study resources and reduce the potential for staff turnover. Suzanne will outline how her clinical research workload tool gives her insight into coordinator performance to help her determine where to allocate studies and resources. Register today!

 

Editor’s note: A version of this article was originally posted on January 29, 2013.

 

4 Comments

4 thoughts on “Has the Study Coordinator Landscape Reached a Tipping Point?

  1. really good article, articulates all the things we as coordinators feel about what we are doing, but didnt realize other coordinators are experiencing the same issues.

  2. I would add that the use of vendors by CROs has increased. Each of these vendors has their own processes that have to be learned. It used to be that the project manager managed these vendors, but increasingly it is the coordinator.

    I sounds like study coordinaotion is becoming more prefessional with the low turn-over rates.

  3. I believe it is imperative that we begin to come to a concensus on core competencies of clinical research coordinators and promote academic programs for the training of clinical research professionals, since despite the professionalization of this specialty area, the greatest number still learn their jobs by the seat of their pants. Training programs are great for those who can afford them, but critical thinking is so important now in this era of complexity. The Consortium of Academic Programs in Clinical Research have published a list of core competencies in clinical research, based on a concensus of stakeholders and are aiming to begin a process of accrediting programs. A list of programs can be found at http://www.coapcr.org. More research that differentiates the roles of nurses and non-licensed, non-nurse coordinators and scope of licensure should be considered. Outcomes research on best practices, education and training and benchmarking would also be interesting. Developing leaders in this profession is essential. Nurses can join the International Association of Clinical REsearch Nurses, in addition to ACRP, SoCRA and DIA. These are exciting times!

  4. What are some of the largest pain points Clinical Research Coordinators face while managing a site and/or study? Please respond with any type of issue that you might have.

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