Study coordinators are vital members of clinical research teams who play a critical role in ensuring the success of high-quality clinical research programs. Particularly in a research environment that is becoming increasingly complex and competitive, study coordinators help alleviate pain points for contract research organizations (CROs) while adhering to stringent regulatory requirements in multiple regions and countries. Let’s explore how study coordinators help CROs execute, coordinate, and successfully complete clinical trials.  

 

1. Complex Regulatory Compliance

Large CROs face a maze of regulatory requirements in the different regions and countries where clinical studies are conducted. Study coordinators ensure compliance with all regulatory standards, thereby reducing the risk of non-compliance penalties for the CRO. CROs leverage the regulatory expertise of study coordinators at the local and international levels, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), International Council of Harmonisation (ICH), and Good Clinical Practice (GCP) guidelines. Study coordinators are critical in ensuring compliance when conducting all trial activities, including but not limited to accelerating trial start-up, facilitating patient-centered trials, supporting data management, supporting innovative trial designs, participating in strategic planning, and improving trial operations and efficiency. 

 

2. Participant Recruitment and Retention

Participant recruitment for clinical trials is challenging and complex. Failure to recruit and retain participants significantly impacts study timelines and costs. Study coordinators actively facilitate participant recruitment by working with investigators to implement effective recruitment strategies and ensuring that enrollment goals are achieved1. Study coordinators and CROs prioritize patient comfort, informed consent, ongoing communication, and quick action on adverse events to protect patient safety. By maintaining participant engagement through study coordinator traits of empathy, understanding, and sensitivity, study coordinators also help improve retention rates. 

 

3. Data Management Challenges

Data management challenges include maintaining data quality and integrity, protecting patient privacy, ensuring data security, collecting and integrating data (for multi-center trials), and ensuring regulatory compliance. Further, data monitoring and quality assurance are resource-intensive and time-consuming. To ensure accuracy, completeness, and confidentiality, study coordinators oversee the collection, management, and storage of study data, maintain sound source documentation practices, and collect primary data in the case of adverse events. In addition, study coordinators manage central and local lab reports and use electronic data capture (EDC) systems that enable real-time data entry, automatic data checks, and remote monitoring.   

 

4. Communication Barriers

Another pain point for CROs is poor communication between the sponsor, clinical research sites, and other stakeholders, which leads to avoidable delays. Study coordinators are the primary contact point between the sponsor and clinical trial sites. They can strengthen communication and collaboration between stakeholders by acting as a central communication hub to facilitate clear, consistent, and effective communication. This includes coordinating with vendors and managing multiple trial sites to ensure smooth operations and consistency across sites. Study coordinators also keep participants informed with updates and provide any clarifications they need, e.g., information on study procedures, risks, and benefits.  

 

5. Adherence to Protocols

Once a study has begun, CROs may face issues ensuring that all clinical trial sites adhere to study protocols. Study coordinators contribute to research-related activities, including protocol design and review, so they are well-positioned to monitor and enforce protocol adherence while addressing deviations promptly. Regarding the study coordinators’ role in improving communications, they also establish communication channels to monitor participant safety and adherence to study protocols. 

 

6. Drug Safety Monitoring

Drug safety monitoring is a top priority for study coordinators and essential for developing safe and effective interventions. Monitoring starts with preclinical toxicology studies and continues throughout the drug’s entire life cycle. Monitoring clinical trial participants’ safety is paramount as the drug safety profile is still being studied. Study coordinators can oversee safety monitoring processes and monitor participant safety and well-being throughout the trial, ensuring that adverse events are reported and managed promptly according to protocol. 

 

7. Resource Allocation & Trial Efficiency

Keeping a clinical trial on schedule and within the allocated financial parameters is challenging yet crucial as mismanagement of resources, including staff and budget, affects trial efficiency. Study coordinators centralize coordination tasks, streamline trial operations, reduce the administrative burden on clinicians, manage schedules, and adjust timelines to keep the study on track. They understand budget components, manage the trial budget and resources, track expenses, and implement prudent financial management. Financial management contributes to improved resource allocation, study sustainability, and trial efficiency. TFS strategic resourcing solutions (SRS) give customers access to a pool of experienced study coordinators that affords them the flexibility and scalability to deploy resources where and when needed most, ensuring that each study receives the attention and expertise it requires. 

 

8. Quality Control

Maintaining high-quality standards across all study elements is critical to ensure the integrity of the clinical trial and the validity of study results. Study coordinators implement and monitor quality control measures, ensuring the trial meets all quality benchmarks. While no single research team member is expected to fulfill all tasks needed to maintain high-quality research, a recent Italian survey involving 319 oncology sites revealed an association between study coordinators and quality. More than 80% of respondents reported that the improvement of the research quality was associated with the inclusion of a coordinator in the research team. 

 

9. Adapting to Changes

Clinical trials often face unexpected changes and challenges. As study coordinators participate in the strategic planning of clinical trials, contributing to site selection, timeline estimation, contingency planning, and ensuring that measures are in place for compliance with all regulatory standards, they are well-equipped to manage unexpected challenges. Study coordinators help CROs adapt strategies and plans to stay on course while maintaining the study’s integrity. 

 

10. Training & Compliance

One resource challenge CROs face is ensuring that all site staff are adequately trained and adhere to compliance requirements. Study coordinators manage training programs and monitor compliance, reducing the risk of errors and non-compliance. They provide training and supervision to site staff to ensure all procedures are performed correctly and consistently across sites. In addition, study coordinators keep up to date with the evolving clinical research environment, emphasize continuous learning and professional development, and advance their skills to consistently care for study participants and contribute to developing innovative life-saving interventions.  

 

TFS Strategic Resourcing Solutions (SRS) 

TFS HealthScience is a global CRO that supports biotechnology and pharmaceutical companies throughout their clinical development journey. In partnership with customers, we build solution-driven teams working for a healthier future.

TFS Strategic Resourcing Solutions (SRS) provides customized global resourcing solutions that enable organizations to manage their clinical trials with greater efficiency, quality, and flexibility. Our solutions are people-based. We listen to and deliver the highly qualified extra capacity team members you need and when and where you need them. From a single resource of one study coordinator to an entire managed team, we deliver quality through our talented professionals, intelligent processes, and deep technical expertise. All TFS Resourcing Solutions offer the benefits of flexibility of resources, access to experts and skilled resources, team and management efficiency, cost efficiency, and the ability to focus on your core business and outcomes.

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