Deborrah Norris* has worked in the pharmaceutical industry for more than 20 years. She started in the industry as a Clinical Research Coordinator, has worked as a Clinical Research Associate, CRA Manager, and Project Manager and Director for several major pharmaceutical companies, and is certified to conduct site audits of clinical trials.

Clinical Research Coordinator Handbook, 4th Edition

She has a wide range of experience in many therapeutic areas, and Ms. Norris has made significant contributions to the development of new compounds. Her experience in the industry includes, but is not limited to, medical writing and the training of allied health professionals on the clinical development process and GCP/ICH guidelines.

Ms. Norris has presented at several international conferences and has performed training for European Clinical Research Associates for several major pharmaceutical companies, including the development of videotaped material used as an adjunct to the presented training materials. She has also been invited to present internationally on pertinent informed consent issues.

Ms. Norris’s Clinical Research Coordinator Handbook was the first handbook published to provide Clinical Research Coordinators with information to assist them in their role as a Study Coordinator. She has written four editions of this handbook, one of which was translated and published in Japan.TheThird Edition received a favorable review from theGood Clinical Practices Journal.Glossary of Lay Language Synonyms for Common Terms Used in Informed Consent Documents for Clinical Studies: A Handbook for Clinical Researchers In addition, her publications are used to teach both GCP/ICH guidelines in several medical schools across the country.She also authored the book,Glossaryof Lay Language Synonyms for Common Terms Used in Informed Consent Documents for Clinical Studies:A Handbook for Clinical Researchers.

Ms. Norris prides herself on her ethics and ability to work successfully with Study Coordinators to ensure the successful completion of clinical trials. As a former Clinical Research Coordinator, she recognizes the valuable role of a Study Coordinator to the success of any clinical trial. She believes the Study Coordinator is the heart of research.

* Deborrah Norris is the pen name used for her publications to avoid any perception of utilizing her site relationships to purchase her publications in order to obtain financial gain.