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Job #02938

About our client Our client is a rapidly growing CRO with well-developed competency in cardiology, men’s and women’s health and endocrinology programs. The company has an experienced management team, strong momentum in their various programs and an empowering corporate culture that is focused on the professional development of its employees. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Clinical Quality Assurance Auditor Chicago, Illinois Salary Highly competitive package, commensurate with experience Responsibilities 1) Write and review SOPs 2) Generate audit reports 3) Conduct ICH GCP training for contract monitors and internal development staff 4) Plan and conduct routine as well as directed audits (both domestic and international) of clinical sites, documentation, etc. to ensure compliance with CFR, ICH and company policies and procedures 5) Provide QA reviews of validation reports and documents 6) Ensure compliance with standards of Good Documentation Practices, Good Clinical Practices and 21 CFR Part 11 Requirements 1) Bachelor’s degree (Master’s preferred) in a Physical or Life Science, Nursing or Pharmacy 2) 5 – 7 years of quality assurance experience within a clinical research or sponsor organization 3) 3 – 5 years of QA and GCP auditing experience 4) Familiarity with current and pending FDA regulations, 21 CFR as well as ICH guidelines 5) Expertise in auditing international clinical trials (GCPs)