Hours of Work :
Days Of Week :
Monday-Friday
Work Shift :
8X5 Day (United States of America)
Job Description :
Your Job:
It is the Manager Research Regulatory Compliance role to oversee, manage, and provide regulatory guidance regarding clinical research activities at Methodist Health System. The Research Regulatory Compliance Manager will work with Institutional Review Boards (IRBs), staff, sponsors, and investigators to achieve regulatory compliance related to the development, implementation, and management of IRB-approved clinical research across Methodist Health System and its affiliates.
Your Job Requirements:
• Masters Degree in Regulatory Science, Healthcare Administration, Legal Studies, or similar discipline - Required.
• Certification from the Association of Clinical Research Professional (ACRP), Society of Clinical Research Associates (SoCRA), or Research Administrators Certification Council (RACC) is highly - Preferred.
• 3 years of experience working in clinical regulatory affairs supporting interdisciplinary research within a large, multi-site teaching hospital and health system.
• Superior computer skills are expected, including high-level word processing and use of the Microsoft Office suite of products.
Your Job Responsiblites:
• Schedule and ensure annual completion of risk-based monitoring for IRB-approved research.
• Maintain Federal Wide Assurance (FWA), System for Award Management (SAM) and Institutional Review Board (IRB) registrations.
• Maintain FDAAA 801 compliance through the Protocol Registration and Results System (PRS).
• Train, supervise, and evaluate activities of CRI regulatory specialists.
• Implement, manage, and update as needed the CRI Quality Assurance Performance Improvement (QAPI) plan and Standard Operating Procedures (SOPs).
• Complete other duties as assigned to support the Methodist Health System Clinical Research Institute and the Methodist Health System Institutional Review Board or its designee(s).
• The Research Regulatory Compliance Manager must demonstrate strong analytical and problem-solving skills; and demonstrate the ability to effectively manage projects, people, and resources in a cross-functional team.
• The Research Regulatory Compliance Manager must be able to help develop, implement and disseminate policies and procedures supporting research compliance initiatives to ensure clinical trials meet or exceed all state and federal regulations.
• Must have reliable transportation and be able to travel locally regularly.
• Perform other duties as assigned.
