An Objective Study of Clinical Research Coordinator Work Quality

The quality of study coordinator work is important to investigative sites, study sponsors, CROs, regulators, and patients.¹ Study coordinators (CRCs) do not work in a vacuum. On the contrary, various factors detract from the quality of CRC work, with uncooperative technology, interruptions, and multitasking being the most prominent.^2,3 To ensure high-quality CRC performance, sites employ a variety of quality control measures. In a mature state, these measures constitute a quality management system (QMS).³

Clinical research associates (CRAs) monitor CRC work and inform them when data corrections or process improvements are necessary. Site monitoring is an expensive and time-consuming process, often accounting for 20% or more of a study budget.³ Nevertheless, on average, even experienced CRAs find only 51% of the critical and major problems presented in monitoring visit simulations, according to Gerald DeWolfe, CEO and founder of CRA Assessments.⁴ Clearly, clinical research quality cannot rely on CRAs alone—CRCs must also do their part, as well.

Study design

This article presents the findings of a study that objectively measured CRC performance under conditions essentially identical to those of the previous CRA study. In this study, conducted by CRA Assessments, participants were informed that they would be taking over a hypothetical study from a CRC who had left the site, not an uncommon exercise. Their task would be to review the study protocol and documentation to identify any issues or outstanding follow-up items. Common significant problems were seeded throughout the documents.

The CRCs performed the following activities:

• Verify that personnel who had completed study activities were correctly authorized on the delegation of authority log.
• Verify that the informed consent process was conducted correctly.
• Verify that participant medical histories were consistent with eligibility criteria.
• Verify that study procedures were completed per the protocol.
• Verify that drug accountability calculations were correct.
• Verify that SAE-related documentation was correctly recorded and evaluated.

These activities were categorized and scored in four domains:

• Delegation of Authority
• Informed Consent Process
• Protocol Requirements
• Adverse Event Identification and Review

Participants

Forty-two CRCs from 10 sites (4 institutional and 6 independent) participated in the study. The CRCs had an average of 6.2 years of experience (<1 to 20 years). The study grouped them into four levels of experience:

• 1 year or less
• 2 to 4 years
• 5 to 9 years
• 10 years or more

The average time to complete the simulation was 3 hours 16 minutes (1 hour 41 minutes to 4 hours 38 minutes).

Findings

Finding 1

CRCs with similar levels of experience exhibit a wide range in the percentage of problems correctly identified (Chart 1). (The red lines denote mean averages.) This level of diversity, combined with the modest sample sizes, makes the subgroup analyses below indicative but not entirely reliable.

Finding 2

Participants identified an average of 45% of problems. As seen in Chart 2, average performance improved with experience, more than doubling from 27% (<1 year) to 57% (>10 years). Performance did not improve from the 2-4-year group to the 5-9-year group.

Finding 3

As can be seen in Chart 3, CRC performance was lowest at Protocol Requirements (36%), higher at AE Identification and Review (48%) and Informed Consent Process (49%), and highest at Delegation of Authority (60%).

Conclusions

CRC performance increases significantly at the two-year level and then again at the 10-year level. However, at every level, performance varies substantially. CRA performance shows a similar pattern. On average, the proficiency of neither CRAs (51% of problems found) nor CRCs (45% of problems found) is impressive, and probably not even acceptable.

Three factors may contribute to improvements in CRC performance over time: selection, experience, and training. Management or self-selection may weed out underperformers. Experience is discussed above. Training can also play an important role.

According to DeWolfe, “The good news is that focused training of CRCs and follow-up simulations can significantly improve performance.” In CRA populations, such training on protocol requirements increases average performance from 51% to 68%. Here again, results vary by individual.

Acknowledgements

Thank you to the sites and study coordinators who contributed their valuable time to this study.

About the author

Norman M. Goldfarb is executive director of the Site Council and founder & CEO of Portolo. Previously, he was chief collaboration officer of WCG Clinical, founded and led the MAGI conferences, and published the Journal of Clinical Research Best Practices.

References

1. "Understanding Study Coordinator Work Quality," Norman M. Goldfarb, Applied Clinical Trials, March 2025, https://www.appliedclinicaltrialsonline.com/view/understanding-study-coordinator-work-quality
2. “The Life of a Study Coordinator,” Cheryl Ryan, Journal of Clinical Research Best Practices, June 2008, https://www.sitecouncil.org:443/Articles/0806 Life.pdf
3. “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
4. “Why CRA Proficiency Needs A Boost From Better Assessment and Training,” Gerald DeWolfe, Clinical Leader, June 20, 2025, https://www.clinicalleader.com/doc/why-cra-proficiency-needs-a-boost-from-better-assessment-and-training-0001