Research Regulatory Compliance Manager

Methodist Health System•Dallas, TX

3d•Onsite

About The Position

The Manager Research Regulatory Compliance role is responsible for overseeing, managing, and providing regulatory guidance regarding clinical research activities at Methodist Health System. This role involves collaboration with Institutional Review Boards (IRBs), staff, sponsors, and investigators to ensure regulatory compliance for the development, implementation, and management of IRB-approved clinical research across Methodist Health System and its affiliates.

Requirements

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, including high-level word processing and use of the Microsoft Office suite of products.
Reliable transportation and ability to travel locally regularly.

Nice To Haves

Certification from the Association of Clinical Research Professional (ACRP), Society of Clinical Research Associates (SoCRA), or Research Administrators Certification Council (RACC).

Responsibilities

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).
Demonstrate strong analytical and problem-solving skills.
Demonstrate the ability to effectively manage projects, people, and resources in a cross-functional team.
Help develop, implement and disseminate policies and procedures supporting research compliance initiatives to ensure clinical trials meet or exceed all state and federal regulations.
Perform other duties as assigned.

Benefits

Faith-based organization with a mission to improve and save lives through compassionate, quality healthcare.
Network of 12 hospitals (through ownership and affiliation).
Nationally recognized medical services.
Renowned teaching programs.
Innovative research.
Strong commitment to the community.
Great Place to Work Certified 2026-2027
Glassdoor’s Best Places to Work 2025 & 2026
Glassdoor’s Best Places to Work in Healthcare, Biotech & Pharma 2026
TIME’s Best Companies for Future Leaders 2025 & 2026
Newsweek’s America’s Most Admired Workplaces 2026
Glassdoor’s Best-Led Companies 2025
Fortune Best Workplaces in Health Care 2025
Military Friendly Gold Employer 2025
Becker’s Hospital Review 150 Top Places to Work in Healthcare 2025
Newsweek’s Americas Greatest Workplaces 2025