Work in Arizona Jobs

Job Information

HonorHealth REGULATORY AFFAIRS COORDINATOR II - Medical Plaza III Shea in SCOTTSDALE, Arizona

Overview HonorHealth is a non-profit, local community healthcare system serving an area of 1.6 million people in the greater Phoenix area. The network encompasses six acute-care hospitals, an extensive medical group, outpatient surgery centers, a cancer care network, clinical research, medical education, a foundation and community services with approximately 12,300 employees, 3,700 affiliated physicians and 3,100 volunteers. HonorHealth was formed by a merger between Scottsdale Healthcare and John C. Lincoln Health Network. HonorHealth’s mission is to improve the health and well-being of those we serve. Responsibilities Job Summary This position coordinates, assesses, plans, and facilitates Regulatory Affairs at the Research Institute in the areas of training and compliance, system-wide use of Good Clinical Practice principals, and application of FDA and ICH guidelines. Responsible for the implementation and maintenance of study protocols from planning, through startup, lifecycle and closure. Studies range from industry-sponsored and investigator-initiated investigational agent, tissue acquisition, and chart/imaging review study protocols. Knowledge of clinical research trials regulations i.e., OHRP and the FDA, Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH) is essential. Prepares and submits documents related to the protection of human subjects to the relevant IRB and scientific review groups for new protocol applications, protocol amendments, deviations/violations, continuing reviews, serious adverse event (SAE) reporting Investigational New Drug (IND) Safety Reports. This includes exempt, minimal risk and greater than minimal risk human research protocols. Prepares and submits documents related to the protection of human subjects to the relevant IRB and scientific review groups for new protocol applications, protocol amendments, deviations/violations, continuing reviews, serious adverse event (SAE) reporting Investigational New Drug (IND) Safety Reports. This includes exempt, minimal risk and greater than minimal risk human research protocols. Understand and coordinate with the Supervisor Regulatory Affairs, compliance with regulations as they apply to multi-center clinical research studies. Be knowledgeable of local, state and federal regulations that apply to human subject’s research, including Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations, sponsor guidelines and all Standard Operating Procedures (SOP). Assist research staff and PIs in initiating, following-up, negotiating, and resolving issues regarding current and future submissions; participate in direct discussions with the appropriate regulatory agencies and other parties. Assist physicians and other staff in meeting human subject protection standards in research. As necessary, participate in creation of supporting documents for research involving human subjects. Interacts with the third party monitors for regulatory compliance and responds to regulatory queries. Execute and maintain a system for maintenance of all regulatory documents, including study-specific regulatory binders. Execute and maintain online database for tracking all study documents. Review sponsor guidelines for each study to ensure compliance with Standard Operating Procedures; suggest modifications as necessary for compatibility. Qualifications Education Bachelor's Degree or 4 years' work related experience Required Experience 2 years experience in clinical research, including data coordination, document and regulatory management, regulatory compliance, and quality assurance. Required

DirectEmployers