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ABCs of Clinical Research for Clinical Administrative Support Staff September 2010

Course Description


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 for a well organized Clinical Research Department
  • Describe the responsibilities of various members of the clinical team
  • List the essential documents needed for a clinical trial and become familiar with the proper preparation of many 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 “do’s 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., C.C.R.A., C.C.R.T.

Click here for complete trainer biographies

Course Length Time

2.5 hours; 12:30 - 3:00 p.m. Eastern

Course Dates 

September 13, 2010                      

Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471

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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)