Clinical Quality Assurance Manager I Job

Employer Name: AuditorCrossing	SpiderID: 2460738
Location: Ridgefield, Connecticut	Date Posted: 8/27/2008
Wage:	Category: Accounting/Bookkeeping
Job Code:

Job Description:

Requirements: BS/BA in scientific or health-related field. Four (4) to six (6) years experience in pharmaceutical industry. Minimum of four (4) years auditing experience with two (2) to four (4) years of GCP auditing OR four (4) years of field/ on site monitoring experience as Senior level Clinical Research Associate. Thorough knowledge of Good Clinical Practice (GCP), ICH Guidelines, FDA regulations. Excellent verbal and written communication skills. Good interpersonal skills, ability to interact effectively with all levels of personnel within the organization and externally with investigators and study site personnel. Ability to review documentation, processes and procedures as it relates to clinical trial activities; to identify issues/problem areas; assess compliance; communicate findings to the clinical teams; provide recommendations and guidance to BI management. Working knowledge of MS windows and MS Office Products. Ability to travel % both domestically and international. Multilingual (English and Spanish) is desirable. Plan and conduct GCP audits of clinical research activities to assess compliance with GCP, ICH, FDA, local regulations, protocol and company SOP/WI; with primary responsibility for conduct of clinical investigator site audits, domestic and international. Identify, evaluate, and recommend solutions to problems identified in the performance of GCP audits.

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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:

Contact Name: -	Company Type: Employer
Company: AuditorCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.auditorcrossing.com