In this role, the selected candidate will act as an advisor on clinical quality assurance issues regarding various aspects of the clinical study phases (e.g. patient informed consent forms, investigational plans, amendments, etc.).
The Sr. Clinical Quality Specialist Audit works under only general direction, and independently determines and develops approaches to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
In this role, the selected candidate will be responsible for conducting fieldwork, discussing findings and observations during client exit meetings, preparing work papers to support conclusions, reviewing staff work papers, and preparing written audit reports.
In this role, the selected candidate will conduct audits and/or special reviews of controls and procedures over companys IT infrastructure, systems, development, and business applications in accordance with risk-based audit plan for design and effectiveness of internal controls, including SOX, conduct interviews at all levels of company to gather information, ascertain key risks, concerns, and expected internal controls.