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Tooling Up: Clinical Trials Careers

Credit: Kelly Krause, AAAS

In my years as a scientific recruiter, I have worked in the clinical-drug research field only a few times. At the conclusion of each search, I marveled that this world is huge and so different from the culture I am used to. Then I promised myself to avoid it, because I just didn't understand it. Before long I'd find myself back in it, thanks to a client company with an urgent need.

I've finally read something that helps me understand the field and its major job categories. In this month's Tooling Up column, I'll review some of those categories, as laid out in the book Career Opportunities in Clinical Drug Research by Rebecca Anderson. Anderson's book is a great introduction for anyone considering careers related to drug clinical trials, which is what this career area is all about.

While it's easy to say, 'We hire team players,' that doesn't quite cut it. You need to be the kind of person who really pulls their own weight independently and who can be counted on by her fellow team members.

—Rebecca Anderson

Seven entry points

In this clear and well-written book, readers can read from front to back to understand how the clinical trials process works or dive into a section describing a career path that sounds appealing. The book has seven sections that describe seven career paths available to people seeking to break into the field, followed by four sections about careers that require clinical experience. I won't discuss those here.

- The clinical research associate (CRA). A CRA represents the sponsor company and ensures that proper procedures are followed during the complex, long, expensive clinical trials process.

A CRA position is the most popular way to enter clinical careers, partly because such positions are relatively abundant. CRAs are employed both by sponsor companies and by contract research organizations (CROs), companies engaged by pharmaceutical and biotech companies to help chaperone a drug through clinical trials. Some CRAs enjoy the constant change and the variety of people and drugs they get to work with at a CRO, whereas others prefer to work for a drug company where they can follow a new therapy all the way through.

Either way, a CRA job is heavy in paperwork and requires good organizational and people skills. There's always a lot of travel, as the CRA moves from trial site to trial site, monitoring the trials activities, coordinating documentation, and meeting with clinical investigators.

- The data manager. The data manager and his or her team are the architects of systems that produce data. And because the product of clinical trials is data -- lots of data -- this job is an important one. Before a trial begins, the data manager and her team review draft protocols for the study to ensure that the trial is designed from the beginning with accurate and precise instructions for those responsible for implementing the protocol. The team writes a trial's data-management plan and confirms that all the reporting forms and data-transfer procedures make sense. Once a trial is under way, the group reviews incoming data and maintains its database, ensuring that everyone is following the rules, then hands off the data to the biostatisticians for review.

- The biostatistician. The product of a trial -- the data -- has to be analyzed and interpreted when it starts coming back from the study sites. This is where the biostatistician comes in. The U.S. Food and Drug Administration (FDA) will approve a product only if the data meets certain statistical criteria, so position is very important in a trial's success. Sponsor drug companies use biostatisticians before a trial begins to help set the parameters for data collection and review. But their main work is analyzing the trial data and extracting results.

Because statistics are known to be massaged from time to time to suit the needs of a pharmaceutical company, this area of work is highly regulated. Biostatisticians (and other clinical staff members) are expected to be honest and ethical in their work; the field has its own codes of ethics. Company-employed biostatisticians may be tempted or urged to overemphasize the positive, but they cannot hide the negative.

- The clinical quality assurance auditor. Clinical quality assurance (CQA) auditors inspect all documents and processes for a study to ensure that they all comply with good clinical practice (GCP) guidelines and standard operating procedures (SOPs). This book includes a handy list of the most common acronyms. There are many.

Today, studies are done all over the world, and there is increasing pressure to harmonize standards and procedures. The CQA auditor is in the thick of things in the regulated world of clinical studies, ensuring compliance with ever-changing rules and regulations.

Regulatory Affairs Careers

In addition to the Tooling Up article cited here, Science Careers has published several articles related to careers in regulatory affairs. Here's a sample:

All in the Details: Careers in Regulatory Science

Tooling Up: Little 'r', Big 'D'

November Feature: Scientists in Regulatory Affairs

- The regulatory affairs specialist. I've written before on this topic, and there are several other articles in our archives at Science Careers about regulatory affairs careers. In the book, Anderson describes in detail the work that regulatory affairs specialists do in collaboration with the clinical study team and their involvement with regulatory agencies.

- Clinical safety. The clinical safety professional is responsible for monitoring, coding, organizing, and tracking adverse events that occur during a trial. The clinical safety person is really a patient advocate. He or she must track negative results that occur in a trial and ensure that each patient is given the appropriate medical care. The clinical safety specialist is responsible for reporting adverse events to FDA. Nurses dominate the field, although it's possible for other degree holders to enter if they've had 2 to 4 years of clinical experience.

- The medical writer. One of the most frequent questions we get on the Career Discussion Forum is "how do I get a job as a medical writer?" Given the volumes of information that come out of a clinical trial, there's a lot to write about. Pharmaceutical companies, hospitals, and other clinical trial sites, government agencies, and marketing companies (also known as medical communications companies) employ medical writers. Here are some previous links for material already published on Science Careers about the medical writing career.

Medical Writing Resources

Over the years, Science Careers has extensively covered the medical writing career track. Here are some select articles:

Tooling Up: The Medical Writing and Corporate Intelligence Career Tracks

Working as a Medical Writer

Careers in Medical Writing: Opening Doors

While most medical writing gigs involve useful work, there is a moral hazard in the field that's best avoided: ghostwriting. The following resources will help you steer clear:

Hunting Ghosts

Ghostwriters in the Medical Literature

The Ethical Conflicts of a Medical Writing Career

Final thoughts about clinical jobs

Although my impressions of this book are very positive, I'd guess that the author started writing it before the job-market downturn of the past few years, which has dramatically impacted the pharmaceuticals industry. It's just too optimistic about prospects for finding jobs.

Today, jobs are hard to find in just about every field, including clinical trials. So I asked Anderson to opine about the qualities most useful for people who want to enter this field, whichever track they enter on. "First, the clinical process is managed by a team," she replied. "While it's easy to say, 'We hire team players,' that doesn't quite cut it. You need to be the kind of person who really pulls their own weight independently and who can be counted on by her fellow team members. Secondly, you need to be good with meeting deadlines, which certainly isn't taught in grad school. Thirdly, you need to be able to follow the rules, as this is a highly regulated career. People's lives are at stake."

"And lastly, you need to be open-minded, willing to try new things, open for fresh learning. After all, you're seeing the benefits of new therapeutics in people for the first time. That's incredibly rewarding."

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