Clinical QA Auditor

Clinical QA Auditor

Responsibilities





Reports to the Sr Director Global QA, locally based in Philadelphia, PA



Plan and conduct audits (both domestic and international) of clinical sites, documentation, databases, vendors, or internal systems to assure compliance with the CFR, ICH and WCT policies and procedures;



Generate audit reports



Manage corrective action plans



Provide QA reviews of reports and documents ensuring compliance with GCPs



Facilitate and/or manage regulatory inspections and audits by third parties



Write and review SOPS



Conduct ICH GCP Training







Skills





Oral and written communication skills



Planning and organization skills



Ability to lead and work in teams



Ability to exercise sound judgment and make decisions







Requirements





Working knowledge of FDA regulations, ICH Guidelines



Understanding of standard operating procedures



Ability to understand and coordinate multiple protocols



Oral and written communication skills



Planning and organizational skills



Understanding of clinical research principles and processes



5 years pharmaceutical clinical research or development experience, including clinical monitoring, data management, or regulatory affairs experience, of which at least minimum of 3 years' quality assurance auditing



Domestic and international travel required





Clinical Quality Assurance Auditor