10-Week Clinical Research Associate (CRA) & Clinical Research Coordinator (CRC) Beginner Program (Jul 24 - Oct 2, 2023)

10-Week Clinical Research Associate (CRA) & Clinical Research Coordinator (CRC) Beginner Program is organized by Barnett International and will be held from Jul 24 - Oct 02, 2023.

Description:
The online 10-Week CRA & CRC Beginner Program provides a comprehensive introduction to clinical research and the job functions of the Clinical Research Associate (CRA) and Clinical Research Coordinator (CRC) for drug, biological, and device trials. This program is geared toward individuals seeking a new career or career change into clinical research but hasn’t decided which job track to pursue. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the CRA and CRC.

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 and discuss the investigational product development process, including FDA regulations, ICH guidelines, and Good Clinical Practice (GCP)
• Explain the roles and responsibilities of a CRA and CRC
• Describe the four types of monitoring visits, including the responsibilities of the CRA and CRC in preparation, activities, and follow-up
• Explain the Key Pre-Study Concepts: Role of the Principal Investigator, Site Selection, Clinical Trial Agreement, and Budget Negotiation
• Discuss the role of the Institutional Review Board in clinical trials, define informed consent requirements, and discuss the informed consent process
• Discuss the study site initiation, interim monitoring activities, and data management
• Define safety definitions and reporting requirements for both drugs and devices
• Examine accountability for the investigational product and study closeout visits
• Discuss regulatory compliance and quality assurance as it relates to audits and inspections

Course Outline:
• Module 1: Investigational Product Development, the FDA, and Good Clinical Practice Guidelines
• Module 2: Clinical Research Team: Roles and Responsibilities
• Module 3: The Principal Investigator, Site Selection, and Budget Negotiation
• Module 4: Clinical Study Protocol Elements
• Module 5: Institutional Review Boards, the Consent of Human Volunteers, and HIPAA
• Module 6: Study Monitoring, Data Management, and Study Initiation Visit
• Module 7: Safety Reporting: Definitions and Reporting Requirements
• Module 8: Accountability for the Test Article and Trial Termination Visits
• Module 9: Regulatory Compliance and Quality Assurance: Audits and Inspections
• Module 10: Managing Your Time and Preparing for the Interview