Medical Clinical Research

Amy Kienzle

*** ******* ****** ****

Wayne, PA 19087

Phone: 610-***-****

*******@*******.***

_____________________________________________________

Education

West Chester University- West Chester, PA

Bachelor of Science in Public Health, 1992

Bachelor of Science in Nursing, 1993

Employment

04/1995 - 12/2003

ZENECA Pharmaceutical Group, Wilmington DE

Contract Clinical Research Associate

Anesthesia, ICU Sedation, Pediatric and Adult Migraine, and Osteoarthritis

experience

. Monitoring clinical trials to ensure regulatory compliance

. Assuring data accuracy, consistency, protocol compliance and

facilitating resolution of clinical problems

. Performing 100% source documentation verification

. Writing monitoring reports and follow-up correspondences

. Assisting in the selection of investigators, negotiating and

processing study budgets

. Performing pre-study, initiation, and closeout visits for multi

centered clinical trials

. Completing the review of site files and drug accountability records

. Collecting and reporting serious adverse event data

. Reviewing medical abstracts for IND safety updates

06/1994-04/1995

Product Investigations Incorporated, Conshohocken, PA

Clinical Research Coordinator

. Involved in the entire process of coordinating and implementing

protocols

. Recruiting and screening patients

. Reviewing medical history to ensure patient met inclusion criteria

. Maintaining complete and accurate study files.

. Developing source document worksheets, completing case report forms,

reporting adverse events, and completing data queries

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