Clinical research professionals (CRPs), which include clinical research assistants, clinical research coordinators (CRCs), also called study coordinators, data managers, quality compliance officers, and regulatory affairs specialists, are critical for designing, conducting, and managing clinical trials. Study coordinators have the experience, knowledge, competencies, characteristics, and collaborative relationships built over time to ensure that trials are conducted ethically, safely, and in compliance with regulatory requirements.

Let’s explore the top ten reasons why you should hire a study coordinator and how essential they are to the success of clinical trials.

 

The Need for Clinical Research Coordination 

The critical role of a study coordinator is underlined by the need to comply with procedures, rules, and guidelines required for running multicenter trials. Study coordinators must have relevant training and mastery of competencies to contribute to the research process and support high-quality clinical and translational research.

Study coordinators have a wide range of responsibilities and a central position, maintaining connections and communications with the principal investigator (PI), site staff (e.g., sub-investigator, study nurse), ethics committee, legal office, study participants and their families, sponsor, and contract research organization (CRO).

CRC activities are divided into several areas:

• administrative,
• monitoring,
• data management and statistics,
• researcher-related (e.g., participation in protocol and case report form (CRF) design and review), and
• clinical activities.

The Association of Clinical Research Professionals (ACRP) states that a study coordinator, study site research nurse, or study site coordinator works at a clinical research site under the immediate direction of a PI whose research activities are conducted under Good Clinical Practice (GCP) regulations. Among other tasks, a study coordinator performs site preparation, patient screening and recruitment, patient enrollment, conducts and ensures the quality of CRFs, maintains source documents, and ensures site quality.

On the professionalization of the clinical research workforce, Sonstein et al. describe the necessary competencies as scientific concepts and research design, ethical and participant safety considerations, investigational product development and regulation, clinical study operations, study and site management, data management and informatics, leadership and professionalism, and communication and teamwork.

Ten reasons to hire a study coordinator for your next clinical trial!

1. Planning & Coordinating Clinical Studies

Study coordinators contribute to the design and planning of clinical studies by helping determine the research question, study participants, and study protocols and procedures. They understand the clinical research process and study design options while staying updated with evolving trial designs, e.g., understanding master study protocols and associated inclusion/exclusion criteria and key endpoints. Study coordinators perform well with multiple responsibilities due to their effective time management, organizational skills, problem-solving skills, attention to detail, and ability to adapt to a changing clinical research environment.

CRC training equips CRCs with practical information on informed consent, regulatory procedures, documentation, study initiation and close-out, drug compliance, storage and documentation, institutional review board (IRB) submissions, adverse events, and U.S. Food and Drug Administration (FDA) audits, among other topics.

 

2. Putting Patients First

Study coordinators who understand the importance of interacting with participants with empathy, understanding, and sensitivity ensure a patient-centered approach throughout clinical studies. Patient safety and comfort, informed consent, and ongoing communication are prioritized. Quick action and prompt reporting of adverse events protect patient well-being while maintaining regulatory compliance.

 

3. Facilitating Patient Recruitment & Retention

Study coordinators actively facilitate patient recruitment and retention by working with investigators to ensure enrollment goals are achieved and keeping up with patient engagement to improve retention. Other activities include checking inclusion and exclusion criteria and obtaining informed consent. 

 

4. Regulatory Expertise & Upholding Ethical Standards

Clinical trials benefit from the regulatory expertise of study coordinators at the local and international levels, including the International Council of Harmonisation (ICH) and GCP (ICH/GCP), which ensure studies comply with ethical standards and regulatory requirements. The role of study coordinators is critical in ensuring compliance with ethical standards and regulatory requirements when conducting all trial activities. Coordinators prioritize patient safety, confidentiality, and integrity of the research process, e.g., when managing patient enrollment, randomization, recording information in CRFs, updating data and files, and using interactive web response system (IWRS) and interactive voice response system (IVRS) to record visits.

 

5. Ensuring Efficient Study Documentation

Study coordinators maintain and manage all necessary study documentation. Experienced coordinators hone their detail-oriented record-keeping skills to ensure the accuracy and completeness of clinical study files, patient charts, informed consent forms, site visits (monitoring), adverse events, study protocols (and amendments), and regulatory documents, among other things. 

 

6. Maintaining Data Integrity 

Study coordinators ensure data is captured accurately and securely by maintaining sound source documentation practices. Study coordinators collect all primary data, including the stop and start dates, administration routes, and medicine consumption in the case of adverse events. Depending on the study, coordinators may analyze the data and report findings. Additionally, they manage all central and local laboratory reports. Study coordinators are adept at using electronic data capture (EDC) systems, further enhancing accuracy and efficiency while streamlining communication with sponsors and other study stakeholders.   

 

7. Strengthening Communication & Collaboration

Study coordinators keep participants involved and informed by providing updates, clarifying study procedures, risks, and benefits, and responding to questions and concerns they may have. Ethical standards are kept during all participant engagement.  

Experienced study coordinators bring the added value of having worked and nurtured collaborative relationships with stakeholders, including CROs, vendors, ethics boards, and clinical research sites. As team players, study coordinators also work on strengthening communication and developing collaborations with sponsors, monitors, and regulatory agencies. Further, CRCs develop collaborations with investigators and other teammates by providing support and ensuring seamless study execution.  

 

8. Managing Clinical Trial Budgets

Study coordinators understand budget components and are prepared to track expenses, implement prudent financial management, and keep within the study budget. Senior study coordinators with advanced training and qualifications can tackle more complex issues, e.g., Medicare billing issues or avoiding fraud and abuse in billing. Financial management contributes to improved resource allocation, study sustainability, and trial efficiency. 

 

9. Meticulous from Start to Close

Attention to detail from beginning to end: study coordinators complete close-out activities, including updating all study documentation, ensuring data accuracy, and adhering to regulatory requirements. Once verified by the clinical research associate (CRA), study coordinators archive all documents accordingly.  

 

10. Continuous Learning & Looking Ahead

To consistently care for study participants and contribute to developing innovative life-saving interventions, forward-looking study coordinators keep up to date with the evolving clinical research environment. Emphasizing continuous learning and professional development, advancing their skills, learning about changes in regulations locally and abroad, and being aware of new tech and methodologies, study coordinators continue to bring value to participants, sponsors, and clinical research.  

According to More et al., frequently requested skills of CRCs include GCP knowledge, organization, management, planning, communication, problem-solving, mediation, and flexibility. With growing regulatory oversight and changes in regulatory procedures, the authors anticipate an increase in the demands and expectations of CRCs. 

Senior-level training equips study coordinators with advanced operational, leadership, and technical capabilities related to clinical research operations. Experienced senior study coordinators with advanced training have essential writing and influential communication skills, have project management capabilities, apply quality management systems, develop and execute risk management plans, evaluate and plan for workforce and budget allocations, and perform root cause analysis to resolve non-compliance on-site. In addition, they can describe various statistical methods and concepts, develop randomization lists, and demonstrate performance management strategies to train and mentor junior study coordinators.  

 

TFS Strategic Resourcing Solutions 

Does your clinical trial require study coordinators to help manage multiple sites? TFS HealthScience provides customized global resourcing solutions that enable you to manage your clinical trials with greater efficiency, quality, and flexibility. From a single resource to an entire managed team, TFS delivers quality through its talented professionals, intelligent processes, and deep technical expertise. In response to your needs, TFS offers short- and long-term resourcing solutions, as well as recruitment services for permanent hires, with global expertise that covers all phases and therapeutic areas at all experience levels and competencies.  

TFS HealthScience is a leading global mid-size CRO that partners with biotech and pharma companies with tailored clinical development and resource solutions throughout their clinical development journey.  

Contact us to find out how we combine a large CRO’s full-service capabilities and global reach with the flexibility and personal approach only a mid-size CRO can deliver.