Study coordinators, also known as clinical research coordinators (CRCs), are indispensable players in the realm of clinical research. They help investigators ensure clinical trials are conducted efficiently, ethically, and in compliance with regulatory standards. With clinical trials becoming more complex and competitive as time goes on, investigators and the clinical research industry can expect to see an increasing demand for the study coordinator.

In addition to the benefits these professionals provide for their individual clinical research site, they also serve as the backbone for contract research organizations (CROs) and sponsors, helping alleviate many of the pain points associated with managing clinical trials. There is a wealth of evidence supporting the positive impact study coordinators can have on a research team, suggesting their involvement brings significant improvements in subject recruitment and retention numbers, as well as overall increases in study efficiency.  

With roles ranging from administrator and researcher to caregiver and patient liaison, a study coordinator is essential for any site looking to maximize efficiency from their clinical trials. This article will dive into the value study coordinators bring to the clinical research industry.

Read on and discover the five key reasons why investigators need a study coordinator! 

 

What is a Study Coordinator in Clinical Research?

According to the Association of Clinical Research Professionals in the United States, a study coordinator, also known as a CRC or study site research nurse, operates at a research site under the direct supervision of a principal investigator, conducting research activities in compliance with Good Clinical Practice (GCP) regulations. Study coordinators juggle several key responsibilities within a clinical trial, including but not limited to site preparation, patient screening and recruitment, patient enrollment, and the maintenance of source documents.

In order to carry out these tasks successfully, study coordinators must possess an extensive skill set, which Davis et al. (2002) categorized into 19 general skill types and 25 subcategories. Among these are hands-on clinical skills, the ability to utilize a variety of research-related skills to advance research goals, psychosocial skills, communication skills, and complex organizational skills. Most importantly, investigators require a study coordinator with impeccable organizational and time management skills, as these are central to managing protocols of clinical trials, functioning as a team member, and coordinating with external representatives from CROs, vendors, and sponsors.

Click here to learn how TFS’ strategic resourcing solutions can help build your next study coordination team with the right skill sets using our expert study coordinator services! 

 

Patient Advocacy to Study Advocacy: The Study Coordinator’s Role in Clinical Trials

A study in 1996 revealed that CRCs performed more than 128 different responsibilities, including study assessments, scheduling, escorting patients around research facilities, being a caregiver, and even being a patient advocate. Most notably, study coordinators serve the role of patient interpreter or liaison, ensuring participants have a good understanding of the protocol and helping them make an informed decision on whether to join a trial. Therefore, the study coordinator plays a crucial role in advocating for both the rights of individual research subjects, as well as the collection of accurate and valid study data. In their position as a bridge between sponsors and CROs and investigators and patients, study coordinators must balance various tasks to ensure a smooth and efficient clinical trial experience for all key stakeholders. 

 

Study Coordinators Alleviate Several Clinical Research Pain Points for Investigators

Study coordinators provide significant value to investigators by alleviating common pain points of conducting clinical research. These are five crucial reasons why investigators need a study coordinator to streamline their next clinical trial!

Want to discover ten more reasons why investigators should hire a study coordinator? Visit this article from the TFS Intellect Hub. 

 

1. A Study Coordinator Offers Dedicated Expertise in Study Protocols

Many sponsors and CROs typically face challenges in protocol adherence at research sites following study initiation. However, study coordinators directly combat this issue because their responsibilities include being well-versed in the intricacies of study protocols. Not only do they meticulously follow the guidelines and procedures outlined in the study plan, their hands-on experience and practical insights can often contribute to the development of these protocols to make them more feasible and efficient. Such expertise from research coordinators is crucial for maintaining the integrity of the study and for ensuring that the data collected is reliable and valid. 

 

2. Study Coordinators Provide Investigators Regulatory Compliance Support

Clinical trials are becoming increasingly globalized, with the conduct of multi-center studies spanning several countries, in addition to outsourcing to CROs with a global presence. However, such trials typically involve rigorous procedures, rules, and guidelines that require attention to detail and strict compliance with regulatory standards. At the site level, study coordinators are primarily responsible for ensuring that the study complies with all applicable regulations and guidelines, such as those from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), International Council of Harmonisation (ICH), and GCP guidelines.

Specifically, they provide ongoing management and oversight of necessary regulatory documentation, as well as work closely with CROs and sponsors to complete submissions accurately and on time, thus reducing the risk of incurring any non-compliance penalties. Furthermore, the regulatory landscape is constantly evolving, and along with their investigators, the professional study coordinator stays on top of these changes, helping adapt site practices to stay aligned with new requirements.

To discover seven more ways in which study coordinators help investigators navigate complex regulations in clinical trials, visit this article here! 

 

3. Study Coordinators Play a Key Role in Patient Recruitment and Retention 

Participant recruitment is another significant challenge that plagues most clinical trials. In fact, 80% of studies are delayed due to difficulties in finding enough participants, while 85% fail to recruit enough patients, which then poses further problems later on in the drug development pipeline. Study coordinators play a key role in improving this process by devoting significant resources to identifying potential participants, explaining the study to them, obtaining informed consent, and maintaining regular communication throughout the trial. 

A study coordinator is also often involved with supporting additional strategies to reach potential participants, including community outreach, partnerships with healthcare providers, and targeted advertising. However, the most valuable role of a CRC comes from their ability to build rapport with participants, addressing their concerns and providing support throughout the study. Through strong communication, trust, and empathy, the best study coordinators can foster a positive relationship with clinical trial participants, the importance of which can’t be underscored in helping minimize study dropout rates and improving patient experiences.  

 

4. Study Coordinators Streamline Clinical Trials Data Management for Investigators

Clinical trials often see data management challenges associated with consistently maintaining data quality and integrity, protecting patient privacy, ensuring data security, integrating data from multiple sources, and meeting regulatory requirements. All these tasks are not only complex, but they are resource-intensive and time-consuming for investigators and their research teams. One of the main responsibilities of a study coordinator is collecting, recording, and managing the study data, as well as entering it correctly and securely into electronic case report forms (eCRFs). These can range from study visit data, patient-reported outcome (PRO) questionnaire data, adverse events and safety reporting, and laboratory data.

However, data management is more than just entering data; study coordinators also perform quality checks to identify and address any discrepancies or errors in the data, working closely with clinical research associates (CRAs) to confirm the data is complete and ready for analysis. Additionally, study coordinators are responsible for maintaining data confidentiality and security, adhering to strict protocols to protect participants’ personal information. Lastly, the meticulous documentation maintained by an experienced CRC when collecting and entering clinical trial data becomes crucial for CROs and sponsors later during audits and reviews.  

 

5. The Study Coordinator is Crucial for Coordinating Clinical Research Activities

Clinical trials involve multiple activities and stakeholders, including investigators, participants, regulatory bodies, and sponsors; however, study coordinators can be considered the central point of contact, coordinating all study-related activities and communications between each of these involved parties. They schedule visits, manage study supplies, address requests raised by the CRO and sponsor teams, and ensure that all parties are informed and on the same page throughout a clinical trial’s lifecycle. In many cases, study coordinators may also be required to solve logistical challenges for investigators and patients, such as arranging transportation for participants, managing study budgets, and coordinating with external vendors. Their ability to juggle multiple tasks and several stakeholders is key to maintaining momentum and success in clinical trials, while minimizing delays in study timelines.

To read more about the pain points that study coordinators help investigators, CROs, and sponsors overcome, visit this article on the TFS Intellect Hub here! 

 

Why TFS HealthScience is Your Partner in Clinical Trial Excellence

Experience the unparalleled expertise of professional study coordinators aligned according to your needs and discover the difference they make in your clinical trials. At TFS, we are dedicated to providing top-notch study coordination services to ensure your trials run smoothly and efficiently.

Here’s how we can help: 

• Expert Coordination for Faster Time-to-Market: Our seasoned team of study coordinators is committed to streamlining your processes and reducing delays, helping you bring your treatments to market faster.  

• Compliance & Quality at Every Step: Our study coordinators are well-versed in industry regulations and best practices, meticulously managing every aspect of your trial to meet and exceed compliance requirements.  

• Tailored Solutions for Every Trial: TFS offers customized solutions tailored to the specific needs of your study. Whether you’re in the early phases of planning or deep into execution, our study coordinators adapt to your requirements and go above and beyond to deliver excellence. 

 

Partnering with an experienced CRO like TFS for study coordination services can significantly enhance the efficiency and accuracy of your clinical trials. Our study coordinators are essential for driving clinical development programs, anticipating and overcoming challenges, and maintaining trial efficiency while adhering to study protocols and staying compliant with regulatory standards. Choose TFS as your partner in clinical trial excellence and experience the difference that professional study coordination can make!

Wondering what else TFS’ Study Coordination Services can offer your next clinical trial? Read about the Key Benefits of Partnering with TFS here! 

 

Conclusion

In conclusion, the multifaceted role of a study coordinator encompasses a wide range of responsibilities that are critical to the successful execution of clinical trials. Their specialized knowledge, attention to detail, and organizational skills enable them to manage complex study protocols, navigate regulatory landscapes, engage and retain participants, ensure data integrity, and coordinate diverse study activities. By alleviating the impact of these pain points on investigators, study coordinators allow researchers to better allocate their efforts and resources to advancing scientific knowledge and improving patient outcomes. 

 

About TFS HealthScience CRO

TFS HealthScience is a global CRO that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. As a trusted CRO partner throughout the entire clinical development journey, we understand the importance of providing essential and diverse services to streamline study management for our clients. Visit our website to learn more about the modern study coordination solutions TFS can offer for your next clinical trial, or connect with a TFS representative today!