Understanding Study Coordinator Work Quality

The quality of study coordinator work is important to investigative sites, study sponsors, CROs, regulators, and patients. Site quality management systems and study sponsor and CRO site monitoring programs largely focus on the work product of study coordinators.¹ To better understand the driving forces behind the quality of site coordinator work, the Site Council conducted a survey of members. Survey findings follow.

Chart 1. How would you best describe your site(s)?

The 38 respondents represent a diverse range of investigative sites.

Source: The Site Council

Chart 2. Within the context of all your competing priorities, how important is the quality of your study coordinators’ work to the success of your site?

Most respondents (92%) consider quality to be extremely important, and all consider it to be at least very important.

Source: The Site Council

Chart 3. How much do study sponsors (left) and CROs (right) seem to care about the quality of your study coordinators’ work?

Respondents believe that almost all study sponsors and CROs consider quality to be important. However, respondents believe that more study sponsors (39%) than CROs (29%) consider it to be extremely important.

Source: The Site Council

Chart 4. How many of your study sponsors and CROs would pay a premium for high quality work by your study coordinators?

Respondents believe that investigative sites should be able to—and may already—charge premium prices for high quality. However, in the respondents’ view, many of the sponsors and CROs that say they care about quality, may not, in fact, be willing to pay for it.

Source: The Site Council

Chart 5. To what extent do you promote the quality of your study coordinators’ work to study sponsors and CROs?

Most respondents (87%) always or usually promote their quality to study sponsors and CROs. This finding supports the conclusion that, in their experience, respondents believe that quality is important to study sponsors and CROs.

Source: The Site Council

Chart 6. How would you assess the quality of your study coordinators’ work?

All respondents rate their study coordinator work as generally good to generally excellent. Ratings of “generally high” to “generally good” suggest that respondents believe their sites have room for improvement.

Source: The Site Council

Chart 7. How important would it be to improve the quality of your study coordinators’ work?

The majority of respondents (61%) consider it extremely important to improve quality. All but two respondents (who believe they have no room for improvement) consider improvement to be at least somewhat important.

Source: The Site Council

Chart 8. Which of the following factors significantly detract from the quality of your study coordinators’ work?

Respondents believe that numerous factors significantly detract from quality. Sixty-eight percent of respondents consider uncooperative technology to be a significant factor. Sixty-three percent of respondents consider interruptions and multitasking to be a significant factor. The other factors all scored in the 26-45% range, meaning they are less common but still important factors.

Source: The Site Council

Chart 9. When hiring a new study coordinator, how do you assess the quality of the work you can expect?

Respondents’ sites employ a wide variety of methods to assess the quality of the work they can expect from a new study coordinator. Interview (82%), experience (76%), resume/C.V. (63%), and trial period (58%) are the most common methods of assessment. Only 26% of respondents use a test of knowledge or a test of skills to assess the quality of the work they can expect from a new study coordinator.

Source: The Site Council

Chart 10. How do you assess the ongoing quality of your study coordinators’ work?

Respondents’ sites employ a wide variety of methods to assess ongoing quality. Internal quality control (92%) and sponsor/CRO monitoring (61%) are the most common methods.

Source: The Site Council

Conclusions

Although most respondents believe that high-quality study coordinator work is very important, most also see room for improvement. Various factors detract from quality, with uncooperative technology and interruptions/multitasking being the most prominent factors.

Respondents believe that both study sponsors and CROs place a high value on quality. However, they also believe that study sponsors place a higher priority on quality than do CROs.

Respondents' sites primarily rely on internal quality controls and sponsor/CRO site monitoring to assess ongoing quality. The effectiveness of these methods depends on the quality of the internal controls and the site monitoring themselves. The author is unaware of any standard industry measures that sites, study sponsors, or CROs can use to assess the quality of these quality control systems.

Respondents’ sites primarily rely on subjective and indirect methods, e.g., interviews, resumes and experience, to assess the quality of work they can expect from a new study coordinator. They generally do not rely on objective tests of knowledge or skill. Standard validated tests, especially of skill, would seem to be the most objective and reliable way to predict the quality of study coordinator work.

The survey did not assess the importance of study coordinator certification. Site feasibility questionnaires seldom ask about certification, suggesting that study sponsors and CROs do not consider it to be a significant factor in site selection.

Sites generally believe that making a convincing case for very high-quality work should give them an advantage in securing attractive studies and obtaining premium pricing for their services. However, sites seem to question the commitment of some study sponsors and, especially, CROs to quality.

Most factors that detract from the quality of study coordinator work are outside the study coordinators’ control, suggesting that the clinical research industry could do more to support study coordinators in their efforts to deliver high-quality work.

Norman M. Goldfarb is executive director of the Site Council and executive director of the Clinical Research Interoperability Standards Initiative (CRISI). Previously, he was chief collaboration officer of WCG Clinical, founded and led the MAGI conferences, and published the Journal of Clinical Research Best Practices.

Reference

1. “Site QMS-Based Site Monitoring: The New Frontier for Clinical Research Excellence,” Norman M. Goldfarb, Applied Clinical Trials, November 2024, https://www.appliedclinicaltrialsonline.com/view/site-qms-based-site-monitoring-clinical-research-excellence