Product Details
Today’s clinical research coordinator faces challenges and requirements that didn’t exist three years ago.
Revisions to the Common Rule and ICH good clinical practice standards and corporate practice, more than a dozen new FDA guidances and policies, as well as rapid advancements in trial technology all have had an impact on the role of the CRC.
To keep CRCs up to date on their evolving responsibilities, The CRC’s Guide to Coordinating Clinical Research covers almost all facets of today’s CRC job.
This edition of The CRC’s Guide is chock full of information you need, including:
- New responsibilities and requirements in the ICH’s recently revised ICH E6 guideline on Good Clinical Practice, including supervision of investigators
- Recent changes to the federal Common Rule creating new requirements for the protection of human research subjects
- Updates to HIPAA research guidelines
- Influence of evolving technologies on the CRC’s role
- Global initiatives aimed at making the trial site more efficient
- Growing use of news tools and methods, such as electronic data capture and eConsent, wearable devices, patient-reported outcomes and more
- Advice for handling site inspections by regulatory agencies
- More than a dozen new FDA guidances
A vital resource for both novice and experienced clinical research coordinators alike, The CRC’s Guide to Coordinating Clinical Research is a one-volume training masterpiece that covers the roles and responsibilities of all key parties involved in managing clinical trials. It contains helpful tips and strategies for performing the job, checklists, key takeaways and exercises.
In addition the guide covers key topics like specific GCP regulations, principles of informed consent, writing and training on SOPs, IRB requirements and more:
- Site feasibility studies
- Study initiation, monitoring and closeout
- Devices and biologics research
- Documentation and data integrity
- Investigational product accountability
- Interacting with sponsors, CROs and clinical trial monitors
- Adverse event reporting
- Study protocols and case report forms
Stay informed and be prepared to respond to industry changes. The fourth edition of this comprehensive, easy-to-read guide is designed to help you.
Order your The CRC’s Guide to Coordinating Clinical Research copy today.
Who Will Benefit
- Current and prospective CRCs
- Clinical research managers or other clinical research staff with an interest in study coordination
- Health professionals interested in pursuing a career as a CRC
- Instructors conducting internal or external training and education programs
- Sites
- CROs
Here’s what current clinical research associates have to say about The CRC’s Guide to Coordinating Clinical Research:
"As a clinical research professional with 20-plus years of experience, I feel this book should be a required tool for all new and experienced coordinators. This is the most practical tool for clinical research instruction I have ever seen."
— Julie Bouma, Clinical Research Manager, Borgess Research Institute
"[The CRC's guide] is an extremely readable book, conveying the very serious aspects of clinical research but with a touch of lighthearted humor and practical advice. New coordinators will find this book to be a wonderfully comprehensive introduction; seasoned coordinators will find it a valuable resource."
— Susan Radtke, RN, MA, CCRP
Amazon.com customers give it 5 out of 5 stars!
Softcover
Add to Cart
Author:
Sandra "SAM" Sather, MS, CCRC
ISBN-13:
978-1-60430-100-7
Publication date:
August 2019
Page count:
648
Interested in an eLearning option?
The CRC Trainer: An Interactive Companion to the CRC’s Guide to Coordinating Clinical Research was built to support learners in a self-paced journey through the complex material of the guide. It covers all essential aspects of the CRC role and focuses learners on the most important aspects of the guide. Click here to learn more.
eLearning Package
with Softcover Book
$295
Add to Cart