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 Job #02546 Email this job to a friend
About our client
Our client is a reputable, mid-size CRO that is experiencing unprecedented growth. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees.
Position Location
Clinical Quality Assurance Auditor (Home-Based) Across North America
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Assist with the development and maintenance of audit programs (internal and external) as part of the quality assurance program
2) Enhance worldwide clinical quality assurance programs
3) Audit ongoing studies, systems and documents
4) Ensure quality assurance compliance with regards to ICH/FDA, GCP, SOPs, national/local guidelines and the EU directives
5) Update senior management regularly on the level of compliance and compliance issues
6) Recommend corrective actions/improvement in procedures and training requirements
7) Generate audit plans and report for sponsors and management
8) Promote quality standards and awareness for all company staff
9) Provide GCP/QA consultation for all company staff
10) Assist in sponsor audits at sites and at company offices
11) Keep abreast with relevant guidelines and assist with all the internal training and training of junior auditors
12) Assist in the review of company SOPs
Requirements
1) Life Sciences/Nursing degree
2) Minimum 2 years of experience in a GCP environment
3) 3+ years of GCP auditing experience for a CRO or pharmaceutical company
4) Experience in mentoring/training junior auditors
5) Experience in formal GCP training (at a company or via institution)
6) Proven knowledge of ICH, GCP and relevant European directives and guidelines
7) Excellent communication and interpersonal skills
8) Superb attention to detail

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