My name is May and I spent my summer as a scientific assistant in the clinical pharmacology department at BioPharma Services. As a student majoring in genome biology and global health at the University of Toronto, my interests lie in the application of scientific topics to health policy and clinical research. Being part of a clinical research organization offered me unique opportunities and insights into the clinical research process, further fueling my passion for the health field, and enriched my own knowledge and expertise.

A Day in My Role as a Clinical Pharmacology Assistant

Working remotely means everything I need is on my laptop. I maintain regular communication with my supervisor and assist on Phase 1 and bioequivalence (BE) protocols, informed consent forms (ICF), and summary reports. I work with a team of medical writers and protocol reviewers who are responsible for handling protocols and related documents. Their main tasks include writing and reviewing study protocols and informed consent forms prior to a trial’s beginning, ensuring that information between documents is consistent. 

Though different types of studies focus on different objectives, studies within a category will follow the same format. A quality control checklist comes in handy when reviewing multiple bioequivalence studies in a week, ensuring that each protocol and ICF is reviewed with the same standard in mind.

Some of the projects I take on require me to create comprehensive summaries of study data after a study has taken place. This could be for many reasons, but is mostly to satisfy the sponsor’s specific needs. These summaries still have templates to follow, but the format may have to be changed to accommodate particular study quirks or sponsor specifications. There is always room for improvement even after these summaries are completed, so they undergo quality control and review from the sponsor and our own medical writing team. Changes are discussed and edits are made to ensure that these summaries include the exact information required. This process can span several days or even weeks, which makes finalizing the summary all the more satisfying.

The Skills I Acquired

Working in the clinical pharmacology department has exposed me to many different types of studies, such as bioequivalence studies and phase 1 studies. I’ve learned about how they’re unique from each other, as well as the significance of each type of study for drug development and health research. Being involved in different steps of the clinical trial timeline has given me a more whole understanding of the process, as well as appreciation for the amount of precision and care each little step requires. Much of my time has been spent reviewing documents, but with every document, I am more familiar with clinical trial design and the considerations that go into each decision. The knowledge and skills I have gained are invaluable in my field of study, especially if I want to pursue a career in health research policy.

Why Choose BioPharma Services?

Before BioPharma Services, I hadn’t realized there were so many types of jobs within a clinical research organization. Many people’s default impression of a CRO includes direct contact with drug trials, such as doctors on standby or staff trained in blood draw procedures. After working here, it’s clear that there are a multitude of disciplines working within a single company to assist in the study process. 

Each department is highly specialized and unique from one another, and yet they work in harmony with the other departments to achieve their objectives. There are staff with education in English, finance, pharmacology, chemistry, and so many more, displaying the variety needed to keep a CRO running smoothly.

Learning about and contributing to the clinical research process was especially engaging when I was given opportunities to do so by my fellow staff and supervisors. Some projects and tasks were outside my previous experience, but under gentle guidance, I was able to complete them with success and newfound confidence in my abilities.

In Conclusion

Working at a CRO like BioPharma Services means you can find many different opportunities with people of many different backgrounds. For students, it’s an invaluable experience that will not only impress others, but provide another lens through which to view health and clinical research. I’m confident that the knowledge and skills I’ve gained during my summer with BioPharma Services will help me achieve future academic and career goals. If you’re a student looking for hands-on experience in the clinical research process, I highly recommend applying below!

Read about BioPharma Services Summer Internship in our Bioanalytical Lab and as a Clinical Research Assistant.

BioPharma Services, Inc., a Think Research Corporation and clinical trial services company, is a full-service Contract Clinical Research Organization (CRO) based in Toronto, Canada, specializing in Phase 1 clinical trials 1/2a and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma conducts clinical research operations from its Canadian facility, with access to healthy volunteers and special populations.