Clinical Researcher—December 2025 (Volume 39, Issue 6)
PEER REVIEWED
Tanvi Nakrani, MHA
As clinical trials become increasingly complex and decentralized, the role of clinical research coordinators (CRCs) has evolved beyond traditional operational responsibilities. Today, CRCs are key contributors to site-level innovation, translating sophisticated trial protocols into efficient, patient-focused practices. Their frontline perspective uniquely positions them to bridge the gap between research teams, sponsors, and technology providers. This article explores how CRCs are driving digital transformation in clinical trials, the operational challenges they face, and the essential strategies needed to build a resilient, research-ready workforce for the future.
Clinical Research Coordinators: Driving Innovation at the Site Level
Clinical research is rapidly evolving, with growing complexity in trial protocols and the integration of decentralized models, artificial intelligence (AI), and digital tools. According to the Tufts Center for the Study of Drug Development (CSDD), clinical trials now include more procedures, longer timelines, and more protocol amendments than ever before.{1}
Amidst this transformation, CRCs play a pivotal role not only in managing operations and ensuring compliance, but also in adapting and implementing innovation at the site level. As frontline staff, CRCs often engage directly with new technologies and patient-facing tools, making their feedback vital to ensuring operational success.{2}
CRCs are no longer just executing trial protocols—they are key drivers of site-level innovation. As the direct link between research participants, investigators, and sponsors, CRCs are uniquely positioned to identify operational inefficiencies and offer practical solutions. Industry leaders have emphasized the importance of engaging CRCs in digital transformation, noting that their early involvement in tool implementation increases adoption success and reduces resistance.{3}
Many clinical research sites have transitioned from traditional, paper-based workflows to eSource and eRegulatory platforms. These changes have significantly improved data accuracy, minimized manual errors, and streamlined document access for remote monitoring. The benefits align with broader industry findings eSource systems have been shown to reduce protocol deviations and increase audit-readiness by enabling real-time data verification.{4}
The integration of eConsent, electronic regulatory binders, and digital patient engagement tools can streamline workflows and improve compliance. For instance, in the experience of the company for which the author of this article works, one research site implementing eConsent observed a 40% reduction in patient visit delays by enabling participants to review documents before arriving onsite. In another case, integrating scheduling tools directly into the clinical trial management system (CTMS) reduced appointment conflicts by 25% over a six-month period.
Beyond technology implementation, CRCs play a critical role in making innovation functional. They interpret how protocols meet real-world clinic workflows, train new users, and communicate usability issues to vendors and sponsors. This dual role (both operational and strategic) has become increasingly important as clinical trials grow more decentralized and reliant on digital tools.
Empowering CRCs to participate in innovation planning and decision making is essential. As the Clinical Trials Transformation Initiative highlights,{2} innovation is most effective when driven collaboratively between technology developers, sponsors, and site personnel. When CRCs are part of that dialogue, tools are more likely to align with daily site operations and ultimately improve both efficiency and patient care.
Challenges to Site-Level Innovation
While innovation holds great promise for improving clinical research efficiency, its rollout at the site level is often hampered by practical barriers. One major issue is the top-down implementation of technologies that are not designed with site workflows in mind. According to a survey by the Society for Clinical Research Sites, a significant proportion of research professionals reported that new technology frequently increases their workload due to poor system integration and limited usability.{5}
Training gaps are another significant challenge. CRCs are frequently expected to adopt new tools with minimal onboarding while balancing a full caseload of patient visits and regulatory responsibilities. This leads to increased stress and inconsistent use of platforms, with studies showing that inadequate training is a key factor in poor digital tool adoption and may even compromise data quality.{1}
Vendor support or the lack thereof also plays a role. During implementation of new CTMS and eSource systems, technical issues and unclear communication often delay workflows. These disruptions are not uncommon, as seen in a report from TransCelerate BioPharma that highlights how insufficient vendor responsiveness is a frequent cause of frustration among site teams.{3}
Budget constraints can further limit access to innovation. While sponsors may support technology for a given study, the infrastructure and training costs often fall on the site. Smaller or independent sites may be forced to delay adoption or work with suboptimal systems due to financial limitations.
Lastly, innovation fatigue is real. When tools are layered on top of one another without proper integration such as using separate systems for eSource, eConsent, and patient scheduling staff can quickly feel overwhelmed. This contributes to burnout and reduces the long-term sustainability of digital transformation.
Ultimately, for innovation to succeed at the site level, it must be introduced in a thoughtful, collaborative manner with adequate training, ongoing support, and a genuine understanding of CRCs’ daily responsibilities.
System Downtime and Workflow Disruption
Despite the benefits of digital tools, unplanned system downtime can significantly disrupt site operations. When platforms such as eSource, eRegulatory systems, or CTMS become unavailable—whether due to server outages, software updates, or internet connectivity issues—CRCs may face delays in data entry, patient scheduling, or regulatory documentation. These interruptions can create backlogs, compromise data timeliness, and increase staff stress.
Mitigation strategies include establishing offline data capture processes, maintaining paper-based contingency forms for critical documentation, and ensuring that information technology support is readily accessible during core operational hours. Training CRCs on protocols in their downtime and conducting periodic simulations can help ensure workflow continuity during unexpected outages.
Recommendations and Vision for the Future
To future-proof clinical research and ensure that innovation delivers meaningful benefits, it is critical to put sites especially CRCs at the center of digital transformation. A key recommendation echoed by CTTI is to involve CRCs early in the design and testing phases of technology implementation.{2} Their practical insights can help vendors develop more intuitive tools that fit real clinical workflows rather than disrupt them.
Another essential step is investing in comprehensive, role-specific training. Research by Tufts CSDD shows that adequate onboarding significantly improves technology adoption and reduces early resistance.{1} Training should be ongoing and adaptable, with refreshers available as systems update and new features are rolled out.
Interoperability between platforms is also critical. Many sites are currently burdened with juggling multiple logins and duplicative data entry due to disconnected systems. A more integrated approach where eSource, eConsent, CTMS, and patient engagement tools communicate seamlessly would dramatically reduce CRC workload and increase efficiency.{3}
Empowering CRCs also means providing platforms for their voices to be heard. Creating cross-site feedback forums, peer user groups, or vendor advisory panels allows frontline staff to share practical experiences and co-develop solutions. This collaborative model has been shown to accelerate usability improvements and boost end-user satisfaction.{5}
The future of clinical trials depends not just on groundbreaking science, but on how well the people running the studies are supported. By designing innovation around site realities and empowering CRCs to lead the change, clinical trials can become more efficient, inclusive, and patient-focused.
Conclusion
The clinical trial landscape is undergoing a transformative shift, marked by the integration of digital tools, decentralized models, and increasingly complex protocols. Amid these changes, CRCs have emerged as indispensable agents of operational innovation. Their role in ensuring smooth implementation of new technologies, maintaining compliance, and enhancing patient engagement is central to trial success.
However, without sufficient training, cross-platform integration, vendor support, and strategic inclusion in planning, even the most promising innovations risk falling short. Sustainable progress in clinical research requires systemic investment in the people managing the front lines of study execution.
A future-ready clinical research workforce hinges on recognizing and elevating the contributions of CRCs. By placing them at the heart of innovation efforts, sponsors, vendors, and institutions can ensure that digital transformation truly enhances trial efficiency, data quality, and patient outcomes—ultimately accelerating the delivery of new therapies to those who need them most.
Tanvi Nakrani, MHA, (nakranitanvi@gmail.com) is a Clinical Data and Research Coordinator II with Clinnova Research Solutions in California.
References
- Getz KA, Campo RA. 2020. New Benchmarks Characterizing Growth in Protocol Design Complexity. Tufts Center for the Study of Drug Development Impact Report 22(1):1–4. https://pubmed.ncbi.nlm.nih.gov/29714620/
- Clinical Trials Transformation Initiative (CTTI). 2022. CTTI Recommendations: Embedding Clinical Trial Elements into Clinical Practice. https://ctti-clinicaltrials.org/wp-content/uploads/2022/12/CTTI_Recommendations_Embedding_Trials_in_Clinical_Practice_December_2022.pdf
- TransCelerate BioPharma Inc. 2020. Technology Considerations for Enabling eSource in Clinical Research: Industry Perspective. https://rdcu.be/eS13h
- U.S. Food and Drug Administration (FDA). 2018. FDA Guidance for Industry—Use of electronic records and electronic signatures in clinical investigations. https://www.fda.gov/media/85183/download
- Society for Clinical Research Sites. 2021. The 2021 Site Landscape Survey: A Year in Flux. https://myscrs.org
