Global multi-center clinical trials involve procedures, rules, and guidelines that require attention to detail and strict compliance with regulatory standards. Amidst increasingly challenging regulatory requirements and trial complexity, study coordinators have an essential role in ensuring compliance and high-quality clinical research. Study coordinators have the skills, expertise, and detailed knowledge of clinical research regulatory requirements, e.g., Good Clinical Practice (GCP), and are instrumental in addressing clinical trial management challenges. Strategic resourcing solutions provide sponsors with vital resources, including study coordinators, to help manage clinical trials with greater efficiency, quality, and flexibility.

Let us explore how study coordinators help sponsors navigate complex regulations throughout clinical trials, from early planning to study completion.  

Want to learn more about hiring study coordinators? Read the Top 10 Reasons to Hire a Study Coordinator!

 

The Role of Study Coordinators 

Study coordinators have a wide range of responsibilities and perform activities essential to conducting clinical trials. Coordinators are the main point of contact for research participants and the sponsor’s project management team. They ensure the safety and well-being of participants throughout clinical trials and contribute to administrative (e.g., Institutional Review Board (IRB) submission and contract and budget revision), monitoring (e.g., preparing audits), research-related (e.g., participating in protocol design and review), and clinical activities. Amidst increasingly challenging regulatory requirements, the demands and expectations of study coordinators have increased, requiring additional skills, training, and medical knowledge.

Mora et al. summarized the most important requested skills for study coordinators, which include experience in clinical trials and research, GCP knowledge, and the ability to manipulate biological samples. In addition, organization, management and planning skills, communication skills, problem-solving and mediation skills, precision, and flexibility were most requested of study coordinators.  

 

Regulatory Challenges 

Study coordinators have a detailed knowledge of clinical research regulatory requirements, e.g., GCP and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements. They are instrumental in addressing clinical trial management challenges, including navigating complex regulatory requirements in every region and country where clinical studies are conducted, thereby reducing the risk of non-compliance.

Study coordinators help manage unexpected challenges due to regulatory, operational, and other changes that affect clinical research, adapting strategies and plans to maintain study integrity and progress. They keep track of the evolving regulatory environment, e.g., the impact of the European Medicines Agency (EMA) Clinical Trials Information System that came into effect in January 2022. As indicated by Patrick-Brown et al., the new approval process has had unintended consequences such as increased document burden, barriers to submitting important modifications, and significant technical hurdles.

Below are seven ways study coordinators help navigate complex regulations. 

 

1. Accelerating Trial Start-up

Study coordinators bring their experience and expertise in accelerated start-up and execution of trials to help prevent delays that can adversely impact study timelines and costs. With specialized knowledge of barriers such as disparate regulations, regulatory submission delays, additional requirements after regulatory approval, infrequent ethics committee (EC) and IRB meetings, and regulatory backlogs, study coordinators ensure that studies are conducted efficiently, effectively, and in compliance. In addition, study coordinators implement effective participant recruitment and retention strategies, ensuring that trials meet enrollment targets and participants remain engaged, thereby improving retention.

 

2. Facilitating Patient-Centered Trials

Study coordinators facilitate the design and implementation of innovative trials such as patient-centered, multi-country, decentralized clinical trials (DCTs), which benefit participants in terms of convenience and reduced participation burden. However, such trials may have unique regulatory challenges, e.g., having access to direct-to-participant (DtP) supply of investigational medicinal products (IMPs). While regulatory agencies worldwide demonstrated flexibility for DCTs (including DtPs) during the COVID-19 pandemic, according to De Jong et al., specific regulation for DtP supply of IMP for trials is lacking. Depending on the needs of the trial, study coordinators play a role in ensuring adherence to regulations, including assessing the appropriateness of DtP (considering home storage and in-transit integrity), ensuring participant confidentiality, and establishing communication channels to monitor participant safety and compliance with study protocol6. Monitoring the safety of participants is a top priority for study coordinators.

 

3. Supporting Data Management

Regulatory submissions and safety monitoring require accurate and reliable data. Data management, involving collecting, organizing, and analyzing data generated during clinical trials, is vital for trial success. Study coordinators ensure that database set-up, data entry, and statistical analysis comply with regulatory requirements and GCP guidelines and ensure the accuracy, integrity, and reliability of clinical trial data. They also develop data entry standard operating procedures (SOPs), provide training to the study team, and recognize and escalate data quality trends as appropriate. Study coordinators who are part of strategic resourcing solutions of contract research organizations (CROs) like TFS HealthScience (TFS) have the added advantage of access to a comprehensive data surveillance and risk monitoring tool that improves data quality and promotes patient safety in clinical trials. Further, AI-driven insights and task automation reduce the time to high-quality data and bring operational teams closer.

 

4. Innovative Trial Designs

Global clinical trials constantly evolve, and clinical research problems are becoming increasingly complex. As traditional clinical trial designs have constraints in accommodating complex emerging research questions, adaptive trials, for example, are chosen to address limitations and improve all phases of clinical trials. Adaptive trials allow for prospective modifications, e.g., adaptation of endpoint selection based on the accumulating data in a trial. Study coordinators must be well-versed in the regulatory guidelines on adaptive trials, e.g., the U.S. Food and Drug Administration (FDA)’s 2019 Adaptive Trials Guidance states that the adaptation rule should be pre-specified and statistical hypothesis testing should account for the adaptive endpoint selection. In contrast, the EMA warns against changing the primary endpoint based on interim results of adaptive trials.

 

5. Strategic Planning

Study coordinators are part of the strategic planning of clinical trials, contributing to site selection, timeline estimation, and contingency planning. Throughout the strategic planning process, study coordinators ensure that measures are in place for compliance with all regulatory standards relevant to each country where the trial is conducted. Areas in which study coordinators are involved during planning and execution include, but are not limited to, participant recruitment and retention, data integrity and management, quality control, and enhanced patient care. In times of unexpected change and challenges, study coordinators help adapt strategies and plans to stay on course.

 

6. Improving Trial Operations

Clinical research is highly regulated and, as such, structured in terms of procedures. Due to growing regulatory strictness and trial complexity, Nebie et al. anticipate reduced efficiency and elevated costs of clinical trials. In addition to ensuring that clinical operations (all activities from early planning to study completion) comply with regulatory requirements, study coordinators address operational challenges to increase trial efficiency while maintaining high quality. To this end, study coordinators manage regulatory and ethics submissions, facilitate communication between sponsor, CRO, sites, and other stakeholders, provide training and supervision to ensure procedures are compliant and consistent across sites, manage schedules and timelines to stay on track, coordinate vendors and multiple sites for smooth operations, and provide care and coordination of participants throughout their trial journey, amongst others.

 

7. Improving Trial Efficiency

Study coordinators improve trial efficiency by centralizing coordination tasks and streamlining trial operations. Further, they understand budget components, manage the trial budget and resources, track expenses, implement prudent financial management, and keep within the allocated financial parameters and timelines. Senior study coordinators with advanced training and qualifications can tackle more complex issues, e.g., Medicare billing issues. Financial management contributes to improved resource allocation, study sustainability, and trial efficiency. TFS strategic resourcing solutions 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. 

 

TFS Strategic Resourcing Solutions (SRS)

TFS HealthScience is a global CRO that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, we build solution-driven teams working for a healthier future. Depending on the specific needs of customers, TFS also provides customized global resourcing solutions that enable organizations to manage their clinical trials with greater efficiency, quality, and flexibility. 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.

Contact us today to find out about our short- and long-term solutions and recruitment services for permanent hire, with global expertise that crosses all phases and therapeutic areas at all experience levels and competencies.