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Clinical Quality Assurance Auditor

CTI Clinical Trial Services, Inc


Location:
Raleigh, North Carolina
Date:
10/24/2017
2017-10-242017-11-23
Categories:
  • Clinical Operations
CTI Clinical Trial Services, Inc
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Job Details

 

Office Based Clinical Quality Assurance Auditor - GCP (I, II, or Sr. - level dependent upon experience)

 

Duties and Responsibilities:

Assist/Host Sponsor audits at CTI and assist with FDA Inspections

Assure that issues from Sponsor audits are promptly communicated to the appropriate team members, assist with the development of a corrective action plan and facilitate resolution of all audit findings

Assist with quality assurance training for CTI staff

Conduct Vendor Audits, Internal System Audits, Site Audits and Computerized Systems and Database Validation Audits.  Identify and follow-up on any unresolved audit findings identified in a Quality Assurance Audit

Conduct Sponsor-contracted audits, such as: Clinical Study Report Audits, Clinical Protocol Audits, Clinical Database Audits, Investigator Site Audits, etc on an ad hoc or scheduled basis as determined by the Sponsor and CTI management

Assist with SOP development and review

Assist with SOP system maintenance

Provide content and/or present quality related information at capabilities presentations

Other duties as required

 

Required Qualifications:

Bachelor’s Degree or equivalent combination of education and experience

Minimum 2 years of related experience or relevant pharmaceutical and/or CRO experience in a Quality Assurance department

Comprehensive understanding of GCP/ICH Guidelines and relevant regulations

Excellent verbal and written communication skills.

 

Preferred Qualifications:

Clinical quality assurance audit experience

SQA, CQA or other quality related certification

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