Clinical Research Coordinator Handbook, 5th edition

 

“This extremely useful title is written for anyone planning to implement clinical trials at an institution. … the author has carefully detailed the types of forms, study records, and case report forms. … A powerful appendix and glossary of relevant terms help make this a needed book for any clinical trials office.”
— Journal of Hospital Librarianship

In this fully revised and expanded fifth edition of the essential reference for clinical research coordinators, Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The book's five appendices include a directory of CRC resources, updated forms and checklists, state regulatory requirements and contact information, conversion charts and tables, and a glossary.

This book covers these topics and more:

Federal Regulations/GCP and ICH Guidelines
Clinical Research Coordinator Responsibilities
Investigator Responsibilities
Obtaining Informed Consent/Assent
Creating and Examples of Source Documents
Electronic Data Capture (EDC)
Preparing for Regulatory Inspections
Reporting Study Results

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Single-Case Research Designs: Methods for Clinical and Applied Settings

 

Kazdin's text is a notable contrast to the quantitative methodology approach that pervades the biological and social sciences. The methodology in Single-Case Reasearch Designs focuses on a widely applicable methodology for evaluating interventions, such as treatment, or psychotherapy, using applied behavior anlaysis. However, this revision aims to encompass a broader range of research areas that utilize single-case designs. The text will convey the pertinence of this research methodology to disciplines ranging from psychology and medicine to business and industry. The first edition of this book, which was published in 1982, still sells a steady amount of copies today. The fact that professors continue to use the first edition of this book more than twenty years after it was published is a testament to the quality of information, organization, and narrative throughout the text. The possibility of a revision has professors excited that they can expose their students to a well-written, clear, and updated text that will reflect the current status of single-case research.

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The Clinical Research Associate (CRA) Career & Beyond

 

The Bio Pharmaceutical industry and the drug development sector in particular is a VERY CLOSED industry and difficult to penetrate. For most graduates, the role of a Clinical Research Associate is the first step into the lucrative drug development sector of the Bio Pharmaceutical industry. For readers new to the clinical research industry and the bio pharmaceutical drug development in general, this book gives you a detailed picture of the role of the CRA and may serve as your career guide into this lucrative industry. For the experienced CRAs this book shows you the way forward beyond a CRA career within the clinical research industry. Reading this book you will understand why demand and hiring of Clinical Research Associates has continued to grow year after years despite an economic crisis in all other areas of the world economy. What awaits your career beyond a CRA within the drug development industry years ahead. This book shows readers the future of the clinical research industry. it shows projected clinical research market growth and trends in the foreseeable future. The Clinical Research Associate (CRA) career and Beyond. INSIDE THE LUCRATIVE BIO PHARMACEUTICAL INDUSTRY will help readers answer the following 7 KEY QUESTIONS about the CRA career. 1. What is a Clinical Research Associate (CRA)? 2. Why Do We Perform Clinical Research? 3. What Is The Value And Importance Of A CRA? 4. Who Can be a CRA? Pre-Requirements and Qualifications. 5. How to become A CRA? Ways on how to get into the CR industry 6. Where Is Best To Be A CRA? Contract Research Organization (CRO) or Bio-Pharmaceutical Industry (Sponsors). 7. What Are The Open Career Options Beyond A CRA? For those CRAs with the ambition to grow and develop within the bio-pharmaceutical industry and clinical research in particular, what are the future opportunities and options. Possible career growth options are detailed in the book. In addition the book gives readers an insight about CRA salaries with year 2015 CRA salary benchmark.

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