Methodist Health System
Healthcare
ResearchRegulatoryComplianceManager
“Research Regulatory Compliance Manager at Methodist Health System. Skills: Research Regulatory Compliance Management, IRB Operations, Clinical Trial Compliance. Oversee, manage, and provide regulatory guidance regarding clinical research activities. Work with Institutional Review Boards (IRBs), staff, sponsors, and investigators to achieve regulatory compliance”
What You'll Achieve.
Achieve regulatory compliance related to the development, implementation, and management of IRB-approved clinical research; Ensure clinical trials meet or exceed all state and federal regulations
Industry & Context.
Analytical and problem-solving
Must have reliable transportation, Able to travel locally regularly
What They're Looking For.
Must Have
Masters Degree in Regulatory Science, Healthcare Administration, Legal Studies, or similar discipline, 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, Must have reliable transportation and be able to travel locally regularly
Nice to Have
Certification from the Association of Clinical Research Professional (ACRP), Society of Clinical Research Associates (SoCRA), or Research Administrators Certification Council (RACC)
What You'll Do.
and provide regulatory guidance regarding clinical research activities
Work with Institutional Review Boards (IRBs)
and investigators to achieve regulatory compliance
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)
and evaluate activities of CRI regulatory specialists
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)
implement and disseminate policies and procedures supporting research compliance initiatives to ensure clinical trials meet or exceed all state and federal regulations
How You'll Work.
Team & Collaboration
Work with Institutional Review Boards (IRBs), staff, sponsors, and investigators; Manage projects, people, and resources in a cross-functional team
Process & Methodology
Effectively manage projects
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