Course Description

This course provides the background needed to become an integral part of the clinical research team (for drugs and devices) and explores the need to understand the rationale behind quality performance and team-playing. The roles and responsibilities of Clinical Administrative Support will be discussed in terms of obligations to the study team and the importance of compliance with Standard Operating Procedures and Standard Office Practices. Although the course is designed for administrative staff with less than one year experience, those with some experience may also find this course helpful in providing the rationale for doing tasks in a specific manner, refining their skills, and sharing their experiences and helpful techniques with their colleagues.

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Learning Objectives

• Recognize the importance of a knowledgeable clinical support staff
• Define the common terms used in the field of drug and device research
• Describe the basics of the drug/device development process
• Describe the basic principles of Good Clinical Practice and the regulations that govern clinical research
• Discuss the basics of clinical trial design and use of a study protocol
• List essential Standard Operating Procedures needed
• Describe the responsibilities of various members of the clinical team
• List the essential documents needed for clinical trials and become familiar with the proper preparation of the documents needed to support the trial process
• Discuss the importance of training and maintenance of current training records
• Describe the rationale behind building quality into the filing system
• Discuss the “dos and don’ts” in the event of a regulatory agency audit

Who Should Attend

• Clinical Research Administrative Support Staff

Instructor

Gary B. Freeman, M.S.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.