Training: Clinical Research Associates
Training: Clinical Research Associates
Training Description
Clinical research associates (CRAs) assist in performing controlled trials on drugs. This is a comprehensive and interactive 6 to 10 week Clinical Research Associate (CRA) training that combines web-based, instructor-led, independent studies, case studies, hands-on and assessments. The course also includes mock site visit and field training visits when possible.
The course is designed for persons with or without prior on-site clinical trials experience, seeking qualifications and/or current practical knowledge to effectively work as Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Clinical Data Coordinator in the monitoring of clinical trials globally in all countries that follow the ICH-GCP guidelines for conducting clinical trials. All courses include ICH-GCP certification.
This course will explore best practices for United States FDA and ICH compliant source and regulatory documentation and the tools that can help to get you there. Join us to learn how to best prepare for a monitoring visit or site audit/inspection.
There is also an option for accelerated 4 day training. For information, please contact us training@guosalifesciences.com.
Learning Objectives
- To have an understanding of the drug development process
- Establish foundational knowledge needed to ensure compliant monitoring of in-human clinical studies – from patient recruitment to post-marketing activities
- Provide the tools and best practices needed to ensure successful trial monitoring and the groundwork for continuous improvement
- Ensure CRAs are ready to begin monitoring after training completion through knowledge checks, assessments, and instructor "check-backs."
Curriculum
- Module 1: Introduction to the Drug Development Process
- Module 2: Overview of the Good Clinical Practices
- Module 3: CRA roles and responsibilities
- Module 4: Overview of Protocols and Amendments
- Module 5:Informed Consent & Privacy Statement
- Module 6: Investigational Product (IP) Accountability
- Module 7: Safety Reporting
- Module 8: Essential Documents and Source Data Verification
- Module 9: Deviations, Non-compliance and Fraud
- Module 10: Monitoring and Reporting
An assessment will be performed before and after the training
To begin, please fill out the registration form below:
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