RESEARCH REGULATORY COMPLIANCE MANAGER

Hours of Work :

0800-1700

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 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).

• 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. #LI-BA1

Methodist Health System is a faith-based organization with a mission to improve and save lives through compassionate, quality healthcare. For nearly a century, Dallas-based Methodist Health System has been a trusted choice for health and wellness. Named one of the fastest-growing health systems in America by Modern Healthcare , Methodist has a network of 12 hospitals (through ownership and affiliation) with nationally recognized medical services, such as a Level I Trauma Center, multi-organ transplantation, Level III Neonatal Intensive Care, neurosurgery, robotic surgical programs, oncology, gastroenterology, and orthopedics, among others. Methodist has more than two dozen clinics located throughout the region, renowned teaching programs, innovative research, and a strong commitment to the community. Our reputation as an award-winning employer shows in the distinctions we've earned:

• Magnet® designations for Methodist Dallas, Methodist Charlton, Methodist Mansfield, and Methodist Richardson Medical Centers

• 150 Top Places to Work in Healthcare by Becker's Hospital Review , 2023

• Top 10 Military Friendly® Employer, Gold Designation, 2023

• Top 10 Military Spouse Friendly® Employer, 2023

Methodist Health System is a faith-based organization with a mission to improve and save lives through compassionate, quality healthcare. For nearly a century, Dallas-based Methodist Health System has been a trusted choice for health and wellness. Named one of the fastest-growing health systems in America by Modern Healthcare , Methodist has a network of 12 hospitals (through ownership and affiliation) with nationally recognized medical services, such as a Level I Trauma Center, multi-organ transplantation, Level III Neonatal Intensive Care, neurosurgery, robotic surgical programs, oncology, gastroenterology, and orthopedics, among others. Methodist has more than two dozen clinics located throughout the region, renowned teaching programs, innovative research, and a strong commitment to the community. Our reputation as an award-winning employer shows in the distinctions we've earned:

• Magnet® designations for Methodist Dallas, Methodist Charlton, Methodist Mansfield, and Methodist Richardson Medical Centers

• 150 Top Places to Work in Healthcare by Becker's Hospital Review , 2023

• Top 10 Military Friendly® Employer, Gold Designation, 2023

• Top 10 Military Spouse Friendly® Employer, 2023

Equal Opportunity Employer

It is the policy of Methodist Health System (MHS) to select, develop, and promote employees based on individual ability and job performance. It has been, and will continue to be, the policy of MHS to provide equal employment opportunity to all people in all aspects of employer-employee relations without discrimination because of race, color, religion, national origin, age, sex, sexual orientation, gender expression, disability, marital status, genetic information or ancestry. This policy affects decisions including, but not limited to, an employee's compensation, benefits, terms and conditions of employment, opportunities for promotion, training, development, transfer all other privileges of employment. MHS is committed to maintain a working environment free of intimidation, workplace discrimination and harassment. Retaliation or attempted retaliatory behavior that occurs as a result of an employee's exercise of their rights under this policy or any other statutorily protected right is strictly prohibited and will be grounds for disciplinary action.