The Regulatory Science program at the University of Southern California offers a variety of graduate certificates, a Masters program, and a new Doctorate geared towards regulatory affairs professionals. In the Regulatory Science program, students learn how to guide medical products and foods through the complex regulatory and reimbursement paths required to bring them to market. Regulatory Affairs is an incredibly important part of the drug development process, and in a very real sense plays the key role in determining the success or failure of a drug development program. Ultimately, it’s a company’s regulatory affairs team that must make the case to the FDA that a drug is safe, effective, and deserves to be on the market.
The program has posted a PDF scan of a great article on regulatory affairs careers from The Scientist, which is usually only available by subscription. The article, “For the Hottest Jobs - Go Regulatory”, follows a typical day in the life of a regulatory affairs associate, Joan Kwong, who started her career in the laboratory and made a career switch a few years later. The article offers some great insight on career potential and typical salary ranges.
The article also includes a sidebar piece entitled “So you want to be a regulatory affairs professional - here’s how to get started”. The article notes that one of the hardest things to get used to at first is the abundance of industry-specific jargon and acronyms. A great resource for learning the language of clinical research and regulatory affairs is the online glossary hosted by the Applied Clinical Trials journal. ACT also recently posted an interesting article, “eSubs and eCTD and RPS, Oh My! ” which discusses some of the changes regulatory teams are dealing with as the submission process goes electronic.
Quintiles, the world’s largest contract research organization, produced this series of “South Park”-style videos promoting careers with the firm. CROs can be a great place to start a clinical research career because they provide exposure to a variety of clinical trial protocols and therapeutic areas. The Quintiles website includes a journal that gives an idea of how a clinical research associate spends her time on site visit and office days.
Here’s an amusing look at a day in the life of a CRA (Clinical Research Associate) on a site visit. This video is a parody, but it does give you a sense of what site visits are all about.
A CRA may spend 60-80% of their time on the road conducting these visits. Their job is to monitor the conduct of clinical trials, ensuring that research sites are enrolling patients and carrying out the trial correctly, following both the trial protocol and ICH-GCP conduct guidelines. They review a lot of documentation, check site supplies and generally watch out for problems.
When there are problems, a CRA needs to help get the clinical site staff back on the right track, and so they need to have excellent communication and negotiation skills. It can take a lot of diplomacy to get clinical investigators and their staff to change the way they do things in a busy clinic!
The sound in the embedded clip isn’t synchronized quite right. You can see a higher-quality version at the ResearchPoint site. They are the CRO (Contract Research Organization) that created the video.
You can read more about what a CRA job is all about in this earlier article.
When you’re looking to get your foot in the door and find your first job in the pharma industry, sometimes it’s difficult to know exactly what a particular job entails.
If you’ve ever wondered what a typical day is like for a clinical research associate, then you might be interested by the story of Ann, a lead CRA for the UK-based firm CDSS. When it’s time for a site visit, Ann begins her day at 5am and works through to 8 o’clock.
