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Introduction to Clinical Research
Date: Saturdays
October 25 - November 22, 2008
Time: 9:00 AM to 4:00 PM
Location: Villanova Conference Center, Villanova PA
Fee: $1495.00
27.5 Contact hours
Faculty:

Laurie Carnovale, MS, BS
Regional Monitor Lead
AstraZeneca Pharmaceuticals

Michele Welch, MSN, RN
Senior Director Study Delivery
AstraZeneca Pharmaceuticals

Jo Dole, PhD, RN
Clinical Project Director
AstraZeneca Pharmaceuticals

This course offers an overview of the pharmaceutical research world…an opportunity to explore the multiple responsibilities of clinical research coordinators (CRCs) and clinical research associates (CRAs). In the rapidly growing field of pharmaceutical research there are many opportunities to grow and learn. CRAs are usually involved in extensive job-related travel; CRCs generally work directly onsite with subjects in clinical trials. Course content focuses on key concepts beginning with an overview of the pharmaceutical industry. Roles and responsibilities within the industry and the new drug application process will be reviewed. Clinical research design considerations are also discussed as the foundation for creating a protocol. Participants learn mechanisms to ensure patient safety, including the protection of human rights, FDA regulations, global product safety, IRBs, and tracking and reporting adverse events. Essential components of a CRA skill set will be addressed and complimented by a class targeting the skills needed when job hunting.

"Having this course was a definite factor in not only getting my current position but making a fairly smooth transition into clinical research...I have to give the Clinical Research course credit for helping to prepare me to handle this responsibility."

Martha E. Sweeney, RN, BS
Research Project Manager,
School of Medicine of the University of Pennsylvania
Philadelphia