Asst Dir, Qual & Reg Assr, Clinical Trials - The University of Rochester : Job Details

Leads the Quality Assurance team for clinical research conducted at C - He. T. Ensures clinical data quality, regulatory compliance, and integrity of research documentation while collaborating with internal leaders and Principal Investigators. Ensures that C - He. T is clinical trial audit ready and that there is full adherence to protect patients safety, rights, and well-being. Manages, directs, and oversees all aspects of internal and external quality and compliance systems relating to routine daily operations, as well as establishes new quality standards and compliance systems supporting projects with territories outside of the United States and North America. Ensures compliance with Good Clinical Practices (GCP) and national and international regulatory requirements specific to the biopharma and medical technology sectors through the development, implementation, and oversight of the Quality Management System (QMS). Directs and oversees the day-to-day quality assurance and regula...Clinical, Clinical Research, Quality Assurance, Operations, Clinic, Leadership, Healthcare