If you’re a researcher with a promising therapeutic, device or intervention, there comes a point where someone suggests taking it into a clinical trial. It sounds like the obvious next step and in many cases it is. But the moment you start looking into how to run a clinical trial, you’re met with a wave of unfamiliar job titles, unfamiliar terminology and a process that suddenly feels far more complex than expected.
For anyone outside the clinical operations world, it’s not always clear who does what or why, so many different roles are needed. So, here’s a breakdown of the key players involved in bringing a trial to life and what each of them actually does.
At the top is the Sponsor. In a commercial setting this is usually a pharmaceutical or biotech company. In academia it may be a university or hospital trust. The Sponsor holds overall responsibility for the trial: they define the study objectives, fund the research and take legal responsibility for how it’s conducted.
Most Sponsors partner with a Contract Research Organisation or CRO. CROs are built to manage the operational and regulatory complexity of clinical trials. They work alongside the Sponsor to plan, execute, monitor and deliver the trial.
The extent of CRO involvement can vary. In some cases, the CRO may manage end-to-end trial delivery, including protocol development, site selection, regulatory submissions, clinical monitoring, data management, statistical analysis, safety reporting, and final study reporting. In other cases, a Sponsor may outsource only specific elements, such as site monitoring or pharmacovigilance, depending on their internal capabilities.
Within the CRO, a project manager oversees the entire trial. They coordinate the timelines, manage budgets and ensure that all stakeholders, from sites to statisticians, are aligned and informed. They’re often the central point of contact for the Sponsor throughout the study.
Clinical research associates (CRAs) are responsible for monitoring trial sites. They ensure the protocol is being followed, data is being collected accurately and that any issues at site level are identified and addressed promptly. Supporting them are clinical trial assistants – professionals who manage documentation, version control, ethics correspondence and other administrative tasks critical to keeping a trial inspection-ready.
On the regulatory side, regulatory affairs specialists prepare and submit the trial to ethics committees and national regulators. They ensure that the study design, consent forms, and associated documents meet the requirements for approval – requirements that vary significantly between regions and trial types.
Once the trial is underway, data managers are responsible for building the databases that collect clinical data and for running quality checks throughout the trial. Biostatisticians work closely with the scientific team to design the statistical analysis plan, calculate sample sizes and interpret the final results. Medical writers turn those results into clear, compliant reports suitable for regulatory submission and publication.
Safety oversight is provided by pharmacovigilance teams, who monitor, record, and assess adverse events throughout the trial. They work closely with medical monitors (typically physicians) who provide clinical context and help sites manage any participant safety concerns as they arise.
At the trial sites themselves, the study is led by a Principal Investigator (PI) who is usually a senior physician. The PI is responsible for the conduct of the trial at their site, the safety of participants and the accuracy of the data generated. They’re supported by clinical research coordinators or research nurses, who manage participant visits, maintain study documentation and handle everything from informed consent to investigational product accountability.
Site pharmacists ensure that the investigational product is stored, prepared, and dispensed according to protocol. In more specialised trials, particularly those involving biomarkers or targeted therapies, translational scientists may also be involved to integrate laboratory insights into the clinical framework.
As recruitment timelines become increasingly important, many trials also involve patient recruitment specialists who develop strategies to reach potential participants, communicate study requirements clearly and support retention across the full study duration.
Finally, quality assurance teams play a vital role across every phase of the trial. They help ensure compliance with Good Clinical Practice (GCP), conduct internal audits and support inspection readiness throughout the study’s lifecycle.
And depending on the type and complexity of your study, there may be even more roles involved such as specialist consultants, clinical raters, or Pharmacy and Manufacturing teams. Every trial is unique and assembling the right combination of expertise is key to delivering it successfully.
It’s a long list, and understandably so. Clinical trials involve real patients, strict regulations and often significant risk. That complexity is what ensures trials are reliable, ethical and ultimately deliver results that regulators and clinicians can trust.
If you’re early in this journey and looking to translate an idea into a clinical trial, the best step you can take is to start speaking with experienced teams sooner rather than later. You don’t need to become an expert in every operational role, but understanding who does what can make the whole process much easier to navigate.
At MAC Clinical Research, we work with researchers and emerging biotechs to bring early-stage ideas into real-world clinical trials. If you’re not sure where to begin, we’re always happy to talk through what the path forward could look like.
If you would like to speak to us about our experience in this area, or would like more information on how we can support your study, contact us here.
