Behind the scenes: Understanding the role of clinical operations in clinical trials

Clinical trials are complex processes with many separate yet highly interconnected parts. In order for the trial to be executed smoothly, central management or oversight is needed to coordinate all these moving parts. That’s precisely what clinical operations, or ClinOps, is concerned with. Let’s explore what clinical operations means, what a clinical operations team does and some typical roles within a clinical operations team.

What is clinical operations or ClinOps?

Clinical operations essentially refers to the tasks involved in executing the entire clinical trial, from its design through to its completion. The clinical operations team works to coordinate all the various departments and teams working on different aspects of a trial, both internal and external, to make sure everything is moving forward and in accordance with the study protocol and principles of good clinical practice.

Many companies who frequently sponsor clinical trials have a proficient, effective, and qualified internal ClinOps team to coordinate and oversee the various internal departments and external partners and vendors.

What does a clinical operations team do?

Clinical operations represents the “core” of clinical trials; the central structure of organization, oversight and management that is tasked with making sure everything runs smoothly, safely, and according to schedule, and that teams and departments are up-to-date and working coherently. Thus, the clinical operations team is responsible for managing (and perhaps even planning and/or executing) a wide range of tasks, such as:

• Design of the clinical trial
• Development of the trial protocol and other study documents
• Ensuring regulatory compliance and obtaining IRB/IEC approval
• Identification, activation, and oversight of clinical trial sites
• Appointment of appropriate clinical investigators
• Facilitating communication between various research teams to streamline collaborative tasks and help the study keep moving forward
• Finding, assessing, and choosing external vendors to partner with
• Stakeholder management and communications
• Quality control across departments
• Budgeting and financial management
• Trial closeout and reporting

Overall, clinical operations typically concentrates on the overall efficiency of the clinical trial and its conformance with the study protocol, Good Clinical Practice (GCP), and International Conference on Harmonisation (ICH) guidelines. For international trials, coordinating and overseeing activities across multiple countries and ensuring that the different rules and regulations are respected becomes another major task of clinical operations.

Important skills for clinical operations teams

Communication is one of the most crucial skills for clinical operations teams, as they work to coordinate tasks across various departments and partners which requires frequent communication that needs to be clear and efficient.

The variety of tasks that clinical operations is involved in requires that the team, as a whole, have skills such as planning, organization, formal communication, financial and time management, and strong leadership qualities, as well as expertise in human health and medicine, drug development, and the biochemistry of the study treatment and the condition it is being used to treat.

Roles within clinical operations teams

Clinical operations teams normally involve a variety of positions, each tasked with specific aspects but working together to ensure that the clinical trial runs smoothly. The ClinOps team may be split into various internal divisions, such as:

• Data Management and Statistics
• Clinical Science
• Regulatory and Legal Affairs
• Safety (Pharmacovigilance)
• Marketing

Clinical operations management can be organized into different hierarchies, depending on how many trials the ClinOps team is running, the scope of the trials, and many other factors that would dictate the internal organization of the team. Nonetheless, typical clinical operations roles include:

Director of Clinical Operations: A Director of Clinical Operations is responsible for overseeing and managing the operational aspects of clinical trials. They play a key role in the planning, implementation, and execution of clinical trials and are responsible for ensuring that the trials are conducted according to the protocol, standard operating procedures, good clinical practices, and applicable regulations.They are tasked with overseeing and coordinating the various stakeholders involved in clinical operations, usually across the various sites involved. This role may also be called clinical operations manager, or alternatively, there could be a clinical operations manager working under or alongside a director of clinical operations. Again, there is no “set” structure of a ClinOps team.

Clinical Trial Administrator: This is an administrative position responsible for preparing and reviewing study documentation, organizing investigator and stakeholder meetings, facilitating submissions for regulatory approvals, and other similar tasks.

Clinical Research Associates (CRA): A Clinical Research Associate (CRA) is responsible for monitoring and overseeing the conduct of clinical trials at sites to ensure that the trials are conducted according to the protocol. They generally have a wide variety of responsibilities associated with the smooth running of a site such as conducting monitoring visits, managing study documents, handling and reporting adverse events, communicating with all stakeholders and others.

Conclusions 

Clinical operations teams are essential for coordinating the numerous parts involved in clinical trials. They are responsible for managing the day-to-day operations of clinical trials and they work with sponsors, investigators, and other stakeholders to ensure that trials are conducted in accordance with applicable regulations and standards. Helping sponsors and drug developers get new treatments to market as quickly as possible while guaranteeing patient safety and respecting regulatory and legal frameworks is the overarching skill of a successful ClinOps team.