Are CRCs Reaching Their Tipping Point?

Topline revenue reports from global investigative sites show that they have rebounded from a dismal 2010. Average per site revenue levels in 2011 were up nearly 6% over the prior year. A closer look, however, reveals a community overloading its capacity and reluctant to take on additional infrastructure as clinical trial activity increases. Nowhere is this more evident than among study coordinators, long regarded as essential personnel managing day-to-day responsibilities at the clinical site.

A recent study conducted by CenterWatch documents a critical workforce that 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 seen during the past decade.

Kenneth A. Getz, MBA

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.

Critical asset

The study was conducted online and e-mailed to approximately 12,000 study coordinators worldwide during August and September 2012. A total of 269 professionals from independent research centers, private physician practices, academic institutions, and hospitals responded to the survey. Half of respondents work in for-profit investigative sites while the other half work for academic medical centers or government-funded hospitals. An average of three full-time study coordinators are employed by each site, and the vast majority of sites (93%) also employ part-time study coordinators.

The CRC's workload is quite full and varied: 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.

Mounting workload

Workload—as measured by the number of clinical trials actively managed by each CRC—has increased 7% annually over the past 10 years. The median number of studies managed by a study coordinator on an annual basis jumped from 4.3 in 2001 to 7 last year—based on anecdotal reports from sites—and is expected to be even higher in 2012. The typical coordinator personally oversees an average of 80 patients on an annual basis.

Figure 1. Median annual studies per CRC are steadily on the rise.

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 CRCs 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.

If that weren't enough, coordinators 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.

Flat salaries but low turnover

While workload has grown substantially, CRC salary levels have remained flat—when adjusted for inflation—during the past decade. And nearly 8-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.

Figure 2. CRCs are increasingly dissatisfied with their salaries.

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.

The CenterWatch study also found that more experienced CRCs tend to stay with their employer longer than those with less experience. Almost three-fourths of study coordinators with at least nine years of clinical research experience have been in their current position for seven or more years.

Study coordinators are staying in their positions 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. When asked to rate the biggest benefits of their job, nearly 43% of survey respondents said they found the work was interesting and satisfying. About 20% indicated that working with patients was the best part of their job. Nearly 15% said they liked the flexibility and autonomy offered by the position.

Assuring CRC motivation

Principal investigators and site directors recognize and appreciate that experienced study coordinators can be a competitive advantage. During the feasibility process, sponsor companies routinely ask investigators about their study coordinator's level of experience and number of years at the site.

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 other staff help with data entry, regulatory responsibilities, or scheduling patients.

In the 2012 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%).

Looking ahead

Simplifying protocol designs—a responsibility that rests with the sponsor—would go far in providing relief for site personnel, especially study coordinators. Today's protocols have an average of 170 total procedures administered over 11 visits during a 175-day period. Studies conducted by the Tufts Center for the Study of Drug Development have consistently demonstrated a strong inverse relationship between protocol complexity and clinical trial performance: The higher the level of complexity, the longer the study will take and the harder it will be to recruit and retain study volunteers. 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.

Study coordinators frequently ask to provide feedback on study feasibility early in the process and provide logistical input before a study begins. Active solicitation of CRC feedback and the application of these suggestions when appropriate may also ease coordinator workload.

Sponsors and CROs are also working to form stronger relationships with their site partners. Some of these relationships are designed to offer some relief to CRCs: Both Quintiles and Covance have programs, for example, that provide dedicated liaisons and support teams that can offer practical assistance to site personnel having trouble with administrative tasks, patient recruitment management, and slow study initiation.

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.

Kenneth A. Getz MBA, is a Senior Research Fellow at the Tufts CSDD and Chairman of CISCRP, both in Boston, MA, e-mail: kenneth.getz@tufts.edu