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XBiotech USA, Inc.
CRA
Location: AUSTIN,
Texas-Austin
78744
Posted on:
10/3/2008 11:15:18 AM
Postion type:
Full time
Job Code:
CRA II
Required Education:
Bachelor's Degree
Salary:
DESCRIPTION
The CRA II performs and coordinates all aspects of clinical monitoring and site management. This includes conducting site qualification, site initiation, interim monitoring visits and study close-out visits. The CRA monitors progress of subject enrollment, performs source document verification of electronic Case Report Forms (eCRFs), oversees drug accountability, & manages investigational site to ensure compliance with FDA regulations, ICH/GCP guidelines, & company SOPs. The CRA represents XBiotech and develops and maintains collaborative relationships with investigational sites to troubleshoot and resolve routine study conduct issues and routing data related issues.
The CRA II may participate in the study start up process including development and review of study related tools as well as assist the Clinical Research Manager with planning, writing, distributing and maintaining Clinical study related procedures
REQUIREMENTS:
Minimum Qualifications
• BS/BA or higher in a scientific or healthcare discipline
• At least 2 years experience monitoring phase I-III clinical trials
• EDC experience required
• Proven flexibility and adaptability
• Excellent interpersonal skills
• Must possess computer literacy and proficiency in MS office.
• Must live in the Austin area as this is an office based position
• Valid Driver's License and passport
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