Mci hybrid quality assurance specialist 2

• Ensuring that industry standards of quality are being met and exceeded on an on-going basis
• Providing education and support to Operations staff in the implementation of, and adherence to, processes and workflows, controlled documents, tools, and templates to enhance the quality of deliverables
• Facilitating SOP administrative functions and training for the Office of Clinical Research (OCR)
• Identifying process improvement opportunities, author and provide instruction on new processes for implementation
• Supporting process re-engineering, contribute to the development of training materials while serving as a subject matter expert
• Participating in the creation of a quality and education program through which investigators and research staff involved in the conduct of clinical research, therapeutic and non-therapeutic protocols, will be educated and trained on current industry standards

• Bachelor of Science required
• A minimum of five years experience in clinical research and/or research with at least 2 years in a Quality Assurance role
• Research Certification (e.g. CCRC, CHRC or CCRP) required
• Strong working knowledge of CFR 21, GCP and ICH Guidelines
• Industry, monitoring or QA experience preferred

Strong preference for a candidate with an Oncology background