If you’re new to the clinical research industry, one of the first things you’ll realize is just how complex clinical trials can be, and how many different people are involved in making clinical research happen from start to finish.
The clinical trial process can seem like a maze, with many twists and turns and steps along the journey to the completion of a study, but in reality, it’s more like a pit crew of a race car, all working together on different tasks at the same time to make sure everything comes together.
In this article, we want to discuss some of the key roles on the research team that are involved in the day to day conduct of a study. While not an exhaustive list, these are some of the core team members that make clinical research happen.
The principal investigator for a study is the lead individual at the site that is responsible for leading the clinical trial. They are often a medical doctor and likely a faculty member if the study is being conducted at an academic institution. Their job is to protect the rights, safety and welfare of study participants, ensure the protocol is executed exactly as written, oversee the activities of the research team, and handle all protocol amendments, regulatory compliance paperwork, and reviewing adverse events.
An investigator for a clinical trial can hold a number of responsibilities, including but not limited to a serving as a biostatistician, consenting and/or treating participants, conducting data analysis and determining results, or conducting basic research on collected specimens in a laboratory. Investigators often hold an advanced or professional degree, such as an MD or PhD, but can also include other high-level research staff.
Clinical Research Coordinator/Associate
Clinical Research Coordinators or Associates, often called CRCs or CRAs are a critical research support role that handles the daily conduct of a study. They interact heavily with both participants and investigators, doing things like screening participants, obtaining informed consent, checking eligibility, collecting and entering data, and more. CRCs and CRAs often hold bachelor’s or master’s degrees, but they may or may not be a nurse, which can limit the types of participant procedures they’re able to do due to licensing requirements.
Research nurses hold an active registered nurse (RN) license, and have the same responsibilities as a CRC, plus handling practitioner duties that require an RN license, such as placing IVs, administering drugs or performing exams. While not all research institutions employ research nurses, they are a key player at organizations at which they are utilized.
There are a wide range of roles that go into a clinical trial before it opens to participant accrual, and even more roles that come into play outside of the clinical setting, including regulatory, financial and oversight roles. When clinical research is done well, it can work like that pit crew teaming up to help the car function properly and finish the race.
“When a sponsor partners with a clinical research site, it is essential that roles are well defined. All the key players work together to make everything move smoothly and per protocol. Although the principal investigator is ultimately responsible for everything the site does for a trial, the study coordinators, nurses, sub-investigators, phlebotomists and others play a crucial role in ensuring nothing gets missed,” said Jeffrey Zucker, Senior Vice President, Global Clinical Operations, Site Management & Trial Optimization at Worldwide Clinical Trials. “For example, study coordinators could arguably be the most important members of the team—they keep everything documented with timeliness and quality. In clinical research, documentation is vital. The study coordinator not only ensures all procedures are completed on time with high quality but also confirms proper documentation is completed to the sponsor’s requirements and regulatory parameters.”
One way to help make the clinical research process easier is by using technology like a clinical trial management system. To learn more about how technology can contribute to the study process, download our eBook “The State of Technology in Clinical Research.”