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Publisher:
CenterWatch

ISBN-13:
Softcover: 978-1-930624-60-3
MOBI: 978-1-930624-51-1
EPUB: 978-1-930624-52-8

Publication date:
Softcover:
MOBI & EPUB: April 2013

Page count:
664

Preview sample pages:
Table of Contents

Introduction

Chapter 4:
Roles and Responsibilities in Clinical Trials

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

Authors: , and

Format(s):

Price: $79.00 

Price: $69.00 

Price: $69.00 

Quantity Pricing Details

Quantity:  

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

eBook orders: eBook purchasers will receive an email upon order completion (if received during normal business hours Monday-Friday, between 9 a.m. and 4 p.m. EST, otherwise orders will be fulfilled on the next business day) containing the selected eBook file. Purchasers must provide an active email address during checkout registration. If you experience problems with the eBook file, please contact customerservice@centerwatch.com.

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Return policy: Printed books may be returned in their original condition (shrink-wrapped cover intact) within 20 days of purchase for a full refund. eBook files may be returned within 5 days of purchase if the file is determined to be corrupt or defective only. View the return policy.

Copyright notification: No part of the printed book or eBook edition may be reproduced in any manner without written permission from the publisher. Duplication or sharing of either format in its entirety is strictly prohibited.

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
Quintiles

“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.