Rory Considine is a clinical operations manager at Icon Clinical Research. He explains what his role entails.
“Clinical trials are conducted in highly regulated environments. Drug development starts with an idea or concept that begins in a laboratory. From there, drugs must be shown to be safe and effective in the treatment of a specific disease before they can be licensed. As clinical trials move through the various phases of research, it is imperative that patients are safe, their rights are protected and the data generated from the trial is robust.
“A study protocol details why a drug is in development and how the study must be run. It defines which patients are eligible to participate, how often the patient must visit the hospital for tests and dictates when and how the drug must be administered. The primary role of a clinical research associate [CRA] is to monitor the conduct of the trial and to ensure it is run according to ethical and regulatory guidelines and in accordance with the protocol.
“CRAs also ensure the protection of the rights, safety and wellbeing of study participants and must make certain that the scientific integrity of the data collected is protected and verified. A CRA achieves this highly detailed oversight by routinely visiting hospital sites and performing on-site and off-site monitoring visits. During such visits the CRA will meet the hospital staff responsible for the study. Key tasks during the visit include checking patients were provided with a patient information sheet and have consented to participate, the protocol is being followed to the letter and that data points relating to safety and efficacy are collected correctly and accurately.
Rewarding
“Working as a CRA is incredibly rewarding. Patient safety is at the forefront of your mind. Prior to a study beginning, you learn about the new drug’s potential for improving patients’ lives. You develop a virtual bond with the patients on your studies and there are incredible days when you witness how a patient’s life has improved because of a new study drug that thousands of people have worked on.
“As with all industries, Covid-19 has affected how CRAs work. The primary function of CRAs is to monitor at hospital sites. National lockdowns and hospital staff being redeployed to the frontline to combat Covid-19 meant CRAs’ time on site was significantly reduced. However, patient safety and data integrity could not be compromised and a new way of working had to be developed and accelerated allowing remote monitoring from a virtual setting. This has been achieved out of necessity and there has been nothing more necessary than the development of a vaccine to combat Covid-19 and to protect society, especially the elderly and those with underlying conditions.
“Icon CRAs recently had the honour of monitoring a Covid-19 vaccine study. A global collaboration of patients, doctors, scientists, statisticians and CRAs working on both sides of the globe, 24 hours per day, seven days per week made the successful search of vaccine candidates possible.
“There are many paths to becoming a CRA. A life-science degree is the first step. From there, candidates can gain experience in supportive roles before becoming CRAs. Icon has a graduate programme in clinical research which aims to train budding candidates and to prepare them for careers as CRAs.
“Salaries and benefits are above average for general graduate positions and career opportunities are in abundance. We have many career CRAs at Icon but it is also seen as a good development role for progression to study management and other more senior roles in the industry.”
Opportunities
Bridget McGrath is a regulatory associate at Arthur Cox. She advises clients in the pharmaceutical, biotech, medtech, food and cosmetics sectors in relation to the entire product life cycle, from clinical research and market access to promotion and advertising.
“Ireland has secured a global leadership position in the life-sciences industry and many career opportunities exist as a result of that. Legislation and guidance in the sector are regularly reviewed and updated at both EU and domestic level. When that is coupled with ever-evolving medical and technological advancements, the day-to-day work of a life-sciences lawyer is diverse, challenging and exciting,” she says.
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