Clinical Trial Support - Regulatory Affairs Administrator

About the role

The Clinical Research Support Office within the Division of Research seeks a Regulatory Affairs Administrator to support investigators throughout the life cycle of clinical research involving human participants. This individual will play a vital role in supporting the development of regulatory strategies, providing regulatory guidance, and facilitating the approval process for clinical research.

Responsibilities

• Develops, implements, and manages regulatory strategies, processes, resources, and communications to ensure all activities comply with federal regulations, institutional policies, and sponsor requirements.
• Collaborates with investigators and internal or external stakeholders to plan, develop, review, and support clinical research through the research life cycle.
• Aids investigators with drafting and editing clinical research protocols, submission packets, and related documents.
• Ensures all research materials are clear, accurate, consistent, and compliant with regulatory standards, scientific objectives, and appropriately prepared for regulatory submission.
• Develops and implements institution-wide training and education plans aimed at enhancing the understanding of regulatory requirements including best practices for conducting clinical research.
• Provides guidance and support to investigators on regulatory requirements and product commercialization pathways.
• Assists with the preparation and filing/submission of regulatory documents for protocol compliance and/or product approvals as needed.
• Communicates with regulatory agencies regarding regulatory requirements for investigational drugs, devices, or biological products.
• Tracks and communicates regulatory changes and timelines affecting clinical research and associated products.
• Maintains audit-ready files and documentation for ongoing regulatory compliance.
• Identifies learning needs within the research community and coordinates, plans, develops, and implements regulatory training activities including seminars, presentations, newsletters, and electronic communications.
• Assists with maintenance of website by providing up-to-date information, templates, and other materials.
• Provides advanced training to investigators, other offices, and staff.
• Assists with new staff training and education.
• Stays abreast of research compliance best practices and all applicable institutional guidelines and federal regulations.
• Serves as a subject matter expert in clinical trial operations and related administrative functions.

Requirements

• Bachelor’s degree in applicable fields or equivalent combination of education and experience.
• 6 years of experience in clinical trials, research, or compliance roles, including regulatory support, business/research operations, confidentiality and clinical trial agreements, cost coverage analyses, and handling grants, contracts, budgets, and billing.
• Public speaking, presentation, analytical, negotiating, and collaborative skills to interact effectively with a broad spectrum of constituents, including faculty members, students, high-level administrators, IRB staff, and sponsor representatives.
• Comprehensive understanding of research contracts, clinical trial costs, coverage analysis, and data management.
• Knowledge of electronic submission systems, and/or databases used to maintain all information pertinent to human research protections.
• Ability to multitask and collaborate effectively with others, while also independently managing a wide range of assignments.

Qualifications

• Strong written and verbal communication skills are essential, as well as, public speaking, presentation, analytical, negotiating and collaborative skills to interact effectively with a broad spectrum of constituents, including faculty members, students, high-level administrators, IRB staff and sponsor representatives.
• Ability to work independently with minimal supervision.
• Ability to manage multiple projects (timelines, reviews, deliverables).
• Knowledge of computer use and applications including word processing programs, spreadsheets, and electronic submission systems, and/or databases used to maintain all information pertinent to human research protections.
• Ability to multi-task and work cooperatively with others.

Skills

• Strong written and verbal communication skills are essential, as well as, public speaking, presentation, analytical, negotiating and collaborative skills to interact effectively with a broad spectrum of constituents, including faculty members, students, high-level administrators, IRB staff and sponsor representatives.
• Ability to work independently with minimal supervision.
• Ability to manage multiple projects (timelines, reviews, deliverables).
• Knowledge of computer use and applications including word processing programs, spreadsheets, and electronic submission systems, and/or databases used to maintain all information pertinent to human research protections.
• Ability to multi-task and work cooperatively with others.

Benefits

Salary: $114,000 - $125,000/annually (Compensation will be commensurate to the selected hire’s experience).

Benefits: Medical, prescription drug, dental, vision, life and AD&D, flexible spending accounts, and long-term disability insurance with Texas A&M contributing to employee health and basic life premiums. Up to 12-15 days of annual paid holidays, up to 8 hours of paid sick leave and at least 8 hours of paid vacation each month, automatic enrollment in the Teacher Retirement System of Texas, free exercise programs and release time, professional development opportunities, and educational release time and tuition assistance for completing a degree while a Texas A&M employee.