10-Week Clinical Research Associate (CRA) On-Boarding Program (Jul 11- Sep 19, 2023)

10-Week Clinical Research Associate (CRA) On-Boarding Program is organized by Barnett International and will be held from Jul 11 - Sep 19, 2023.

Description:
The online 10-Week Clinical Research Associate (CRA) On-Boarding Program is appropriate for individuals with less than two years of experience as a CRA. The course provides practical, hands-on training as it relates to the CRA job function, and covers core sponsor and research site activities that promote the successful monitoring of studies for drug, biological, and device trials. Good Clinical Practice (GCP) skills are reinforced through a combination of activities, including lectures, case studies, and scenario reviews, as well as application-based homework assignments.

The course is built on Barnett’s deep in-person CRA training experience and is designed for the “onboarding” of individual new hires or entire teams. If you are a CRA manager or human resources professional responsible for the orientation and training of one new CRA or 100, this course provides a convenient, cost-effective, comprehensive, and interactive training method. You’ll have peace of mind knowing that you are training your new hires to the highest industry standards.

The resources required to take this online course are already at your fingertips – an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information.

Prior to the start of the course, participants will receive Module 1 materials. Course materials for subsequent modules will be sent weekly prior to class. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives:
• Describe the drug development process, the importance of Good Clinical Practice (GCP), and the roles and responsibilities of the research team
• Define the regulatory requirements, explain the differences between ICH GCP E6 and FDA requirements, and describe the elements of a protocol
• Outline required elements of the informed consent
• Identify the investigational product accountability requirements and the impact of the reconciliation process on the study
• Define the safety definitions and comprehend the safety reporting requirements
• Prepare for and perform source document verification
• Perform the steps involved in monitoring the investigational site: Pre-visit, during the visit, and post-visit
• Create cohesive, well-written protocol deviations and action items, and accurately complete the monitoring visit report and site follow-up letter
• Define the impact of quality assurance and audits in clinical research

Course Outline:
• Module 1: Investigational Product Development Process: Drug and Medical Device, Good Clinical Practice (GCP), and Clinical Research Team Roles and Responsibilities
• Module 2: IRB, Clinical Study Protocol Elements and Amendments
• Module 3: Informed Consent
• Module 4: Investigational Product Accountability
• Module 5: Safety Definitions and Reporting Requirements
• Module 6: Source Document Verification
• Module 7: Monitoring the Study
• Module 8 and Module 9: Monitoring Visit Reports, Follow-Up Letters, and Contact Reports
• Module 10: Regulatory Compliance and Quality Assurance: Audits and Inspections