Quality Assurance Manager

Clinical Trials are bound by a protocol as well as other complex rules and regulations. Quality Assurance Managers like Marie-Claire make sure that every rule is followed. “My job is very much to look at the quality of a trial as it’s being run,” she says. “So I make sure that everybody who’s working on the trial complies with all the regulations and rules in the UK.”

Marie-Claire looks at systems and processes in clinical trials, and keeps up with all the changes in regulations. She reads and re-reads complicated documents, and then explains them to the rest of the clinical trial team.”I quite often get called a translator of the regulations,” she says, “They can be quite complex at times. Especially when things get put into UK law and [the trial team] are trying to apply that, that’s what I’m trying to do, to make sure people actually understand.”

Marie-Claire started working in clinical trials as a Research Nurse. She did this for six or seven years, and learned more about the regulatory side of things along the way. Her experience working in clinical trials helps her to communicate regulations to the rest of the team. “I do meet up with quite a lot of the Nurses and the Principal Investigators,” she says, “Just to check that they’re all happy with what they’re doing, and if there’s been a change, we’ll run teaching sessions.”

People who are interested in this kind of role don’t need to take this route into the job. Marie-Claire says,” There are lots of ways into clinical trials. You can become a Clinical Research Assistant, if you’re not a Nurse or a Medic, and actually you don’t need so much science, but at least A-levels help.”

Photo of Marie-Claire Rickard, Quality Assurance ManagerMarie-Claire Rickard, Quality Assurance Manager