| 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
|