Scheduled Classes
All About Clinical Research (Part A)
10/25/2008 - 10/26/2008
Airport Hilton Hotel
1031 Virginia Ave.
Atlanta, GA 30354
800.00
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Registration
View our scheduled dates to the right to register online or call 1-(888)-988-3853.
Description of Course
This training is designed to provide the participant with an excellent introduction to clinical research and the roles and responsibilities of Clinical Research Associates, Clinical Research Coordinators, and Data Managers. It will explore topics and hands-on knowledge relevant to those considering a career as an entry-level monitor, site coordinator, or data manager. Additionally, this course is appropriate for individuals seeking a new career or career change, but do not know which job track within clinical research to pursue.
Who Should Attend
- Aspiring Clinical Research Coordinators
- Aspiring Clinical Research Associates – In-house or Field-based
- Aspiring Clinical Data Managers
- College Students
- Nurses
- New College Graduates – Any Discipline
You will learn to
- Discuss the history of clinical research
- Discuss the Federal code of regulations and ICH/ Good Clinical Practices guidelines
- Define the informed consent process
- Understand the roles and responsibilities of the Clinical Research Associate , Clinical Research Coordinator, and Clinical Research Data Manager
- Understand the role of the investigator
- Define the different study Phases and monitoring visits
- Define Source Documents and Case Report Forms
Course Outline
Day One 9:30 am – 4:00 PM
- Definitions/ Termination / History
- FDA regulations and GCP/ICH
- The Clinical Team – Who they are? What are their Roles and Responsibilities of Clinical Team
- Clinical study protocol - Study Types and Elements
- Exercise Interaction 1
Day Two 10:00 am – 4:00PM
- The clinical investigator
- Study visits - Site selection, Study Initiation, Monitoring, Close-Out Visit
- Preparing a for a job in clinical research – the resume, the interview, the resources
- Exercise Interaction 2