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Softcover: 978-1-930624-60-3
MOBI: 978-1-930624-51-1
EPUB: 978-1-930624-52-8

Publication date:
MOBI & EPUB: April 2013

Page count:

Preview sample pages:
Table of Contents


Chapter 4:
Roles and Responsibilities in Clinical Trials

The CRA's Guide to Monitoring Clinical Research, Third Edition

Authors: , and


Price: $79.00 

Price: $69.00 

Price: $69.00 

Quantity Pricing Details


Jump to: About The CRA's Guide | Reader Comments

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About The CRA's Guide:

The CRA’s Guide to Monitoring Clinical Research, now in its third edition, continues to be a key resource for both novice and experienced CRAs seeking to learn more about the field of monitoring or to better understand their roles and responsibilities as the industry becomes more global and technologically focused. With helpful tips and strategies, checklists, personal experiences, key takeaways and exercises, plus new chapters on CRA roles and responsibilities, monitoring for device and biologic trials, globalization of studies, EDC and more, The CRA’s Guide is a must-have training and educational tool that you’ll refer to again and again.

Topics include:

  • A comprehensive review of CRA roles and responsibilities
  • Understanding regulations and GCPs
  • Study initiation and monitoring plans
  • Recruiting and retaining study subjects
  • The informed consent process
  • Conducting adverse event and safety monitoring
  • Preparing for audits and detecting fraud
  • The future outlook
  • Job descriptions and current academic programs
  • Devices and Biologics
  • Managing Multi-national Trials
  • IRBs and Data Safety Monitoring Boards
  • Exercises with Answers

Recommended for:

  • Novice and experienced CRAs or clinical research monitors, clinical research managers or other clinical research staff with an interest in study monitoring
  • Health professionals interested in pursuing a career as a study monitor
  • Instructors conducting internal or external training and educational programs

Reader Comments:

“Karen’s book is full of the roles and responsibilities of CRAs. There is a continual focus on patient safety and GCP. The chapters are broken down into easy to understand, practical and needed skills and how to implement them. I have recommended this book more times than I can count, it is truly a wealth of information!”

—Carol Radochonski, RN, BS, CCRA
Associate Director, Clinical Operations

“Karen’s CRA Guide is my ‘go to’ resource for all things related to being a CRA. Her extensive experience, expertise and delightful sense of humor really come through in the book. She provides a treasure chest of sample forms, checklists, logs and hints and tips for making the job easier. This book is my bible of how to do the job right. I never go on a monitoring visit without it!“

—Lauren Kelley
Independent CRA

“The CRA’s Guide to Monitoring Clinical Research has been a treasured guide and reference throughout my clinical research career. As a new CRA, it provided the necessary fodder for my introduction to the correct conduct of monitoring visits and the overall drug development process. I utilized it profusely while prepping for my ACRP CCRA certification and attribute the comprehensive content to ultimately attaining this certification. This is truly a training manual with content that shall never become outdated or irrelevant; the crucial knowledge between its sleeves remains consistent with the regulations as well as the best practice guidelines that remain the cornerstone of the CRA role.”

—Elizabeth Weeks-Rowe, LVN, CCRA
Training and Curriculum Development Consultant

Read a review by Norm Goldfarb, Managing Director of First Clinical Research.