© 2010 • 279 pp., illus. (12 b/w), glossary, index
Trim size: 6” x 9”
Hardcover • $61.00 • ISBN  978-1-936113-05-7

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This book is an easy-to-follow handbook that introduces readers to entry-level clinical job opportunities and explains how to qualify for them, with a particular emphasis on how to gain “clinical experience” that a hiring manager will accept.

Each chapter covers one of the clinical specialties involved in conducting pharmaceutical clinical trials: for example, clinical research associate, clinical data manager, biostatistician, and clinical drug safety specialist. The chapters are written as personalized narratives, allowing the reader to follow the daily work of a clinical specialist as he or she supports a clinical study and interacts with the other study team members. The descriptions of these specialists are composite profiles that incorporate the true-to-life experiences of typical clinical study team members. A list of career options available to workers after mastering their entry-level clinical position, as well as a tool box for those seeking a position, are included.

Career Opportunities in Clinical Drug Research also gives readers a brief overview of research and development in the pharmaceutical industry and explains how a typical clinical study is conducted.

About the author: Rebecca J. Anderson has worked in the biopharmaceutical industry for more than 25 years in jobs spanning pharmaceuticals, biotechnology, medical devices, and contract research organizations. As a hiring manager in all of these organizations, she has reviewed and screened thousands of applicants for clinical research positions. Rebecca holds a Ph.D. in pharmacology from Georgetown University and was an MRC Postdoctoral Fellow at the University of Toronto. Prior to her career in industry, she conducted basic research in pharmacology and toxicology and served on the faculties of the George Washington University Medical Center and the University of Michigan School of Public Health. She currently works as a freelance writer.

  “This well-written, superbly organized book offers a former clinical research company hiring manager’s unique perspective, which complements and completes the training and advice students receive in undergraduate and graduate school. Chapter layouts are efficient, with major points bulleted, and concise, clear text categorized under well-planned, meaningful headings...Nothing is omitted from this volume. It would be an appropriate and wise choice for the personal library of any science mentor and all science graduates.”
      —Choice

  This book “clearly explains how to get a job in clinical operations at a study sponsor or contract research organization. The author may be optimistic about finding a job in the current environment, but the situation should improve over time.”
      —Journal of Clinical Research Best Practices

  “The book by Rebecca Anderson....is an excellent resource for job seekers. It would also be helpful for recent hires new to the industry, as well as for more experienced staff who mentor less-experienced colleagues…goes well beyond career opportunities...has an extensive list of reference materials...those new to the industry and those trying to break in to the industry will find this book very helpful...”
      —Global Forum

  “I’ve finally read something that helps me understand the field and its major job categories....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....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 carerer path that sounds appealing. The book has seven sections that describe seven career paths available to people seeking to break into the field....my impressions of this book are very positive...”
      —Science

Preface

Abbreviations and Acronyms

PART 1: BACKGROUND

1. What is the Clinical Environment in Industry?

2. How Are Drugs and Medical Devices Developed?

3. What Happens at the Clinical Site?

PART 2: PATHS TO CLINICAL JOBS IN THE MEDICAL PRODUCTS INDUSTRY

4. Entering as a Clinical Research Associate

5. Entering Data Management

6. Entering as a Biostatistician

7. Entering as a Clinical Quality Assurance Auditor

8. Entering Regulatory Affairs

9. Entering Clinical Safety

10. Entering as a Medical Writer

11. Your Future in Clinical Operations

PART 3: TOOL BOX

12. Helpful Hints for Landing a Clinical Product Development Job

13. Reference Materials

Glossary

Index