The CRA Trainer: An Interactive Companion to The CRA’s Guide to Monitoring Clinical Research

The CRA’s Guide to Monitoring Clinical Research is the go-to resource of the trial monitor, training clinical trial professionals for more than 15 years.

But book learning doesn’t work for everyone, and CRA trainers need more options for a comprehensive, educational tool.

Introducing The CRA Trainer, a new online course and companion to The CRA’s Guide that offers practical exercises, mini-quizzes and real-world scenarios to help guide the trainee through the lessons presented in the book and apply them on their daily job:

• Familiarize yourself with the roles, responsibilities and important personality characteristics of an effective CRA
• Assess clinical trial regulatory history and current rules
• Critically evaluate the research process from the lab to the trial to trial closeout
• Get a sense of roles and responsibilities of IRBs and Data Safety Monitoring Boards
• Identify the principles and challenges of informed consent
• Understand study design and statistical analysis
• Find out more about adverse events and safety monitoring
• Evaluate quality management and prepare for audits
• Learn to identify fraud, mistakes and errors

The course consists of six individual modules that break the information in The CRA’s Guide into easily readable chunks:

• Module 1: CRA roles and responsibilities, regulatory history and compliance, principles of good clinical practice
• Module 2: The clinical research process, device and biologics trials, globalization, IRBs and data safety monitoring boards
• Module 3: Informed consent, preparing for a study, clinical investigators
• Module 4: Study initiation, study monitoring, adverse events and safety monitoring, recruitment, retention and compliance
• Module 5: Study closeout, quality management, audits, errors and misconduct, the future for CRAs
• Module 6: Final Exam — review and test on the previous five modules

Each module takes 20-30 minutes to complete. A certificate of completion is awarded to trainees who pass the final exam.

The six modules of the course can be uploaded to a PC for use by individual trainees without an online connection or added to an organization’s learning management system (LMS) to track and evaluate the progress of multiple trainees.

Whether you are an individual who wants to move up to a career in trial monitoring, an experienced CRA who needs to stay on top of developments in the profession or a trainer preparing groups of trainees to take on the job of CRA, The CRA Trainer is an invaluable tool for gaining — and proving — mastery of the job.

Who Will Benefit

• Clinical trial sponsors
• Academic research centers
• Contract research organizations
• Clinical trial service organizations
• Clinical trial professionals who would like to transition to a career in trial monitoring
• Directors of research and clinical operations
• Trial monitor trainers
• Experienced CRAs looking to advance their careers