Clinical Trial Support - Regulatory Affairs Administrator

Texas A&M University System • College Station, TX

1d • $114,000 - $125,000 • Onsite

About The Position

The Clinical Research Support Office is seeking a Regulatory Affairs Administrator to serve as a subject matter expert in clinical trial operations and related administrative functions. This individual will play a vital role in supporting the development of regulatory strategies, providing regulatory guidance, and preparing and submitting regulatory communications and documents. The ideal candidate will ensure compliance with regulatory standards and facilitate the approval process for clinical research. In this role, you will work closely with investigators, administrators, regulatory agencies, and internal and external groups that support clinical research throughout the project life cycle.

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.
• 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.

Nice To Haves

• Master’s degree in education, business, research, science related or legal field.
• Certified IRB Professional (CIP), Certified Clinical Research Coordinator or Professional (CCRC/CCRP) Certified Clinical Trials Manager (CTM) Regulatory Affairs Certification (RAC) or Juris Doctorate (J.D.).
• Knowledge of biomedical and behavioral research including clinical trials in an institution of higher education.
• Experience with FDA commercialization pathways, INDs, IDEs, PMAs, 510(k)s, documentation packages and annual reports.
• Ability to provide efficient customer service through the preparation, submission and management and maintenance of regulatory submissions.
• Familiarity with funding agency requirements (government, international, private, industry, etc.).
• Knowledge of regulations and ethical principles regarding human research including HIPAA, FDA, OHRP and international standards in addition to above knowledge, skill and abilities.
• Understanding of both compliance and commercialization timelines
• Ability to cultivate and maintain professional working relationships with people of varying backgrounds.

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.
• Assist 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.
• Ensures all documentation and processes follow applicable regulatory standards and best practices.
• 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.
• Assists with study management, tracking, and reporting from feasibility to close out by maintaining databases and records through various systems (CTMS, RedCap, Maestro, etc.).
• Works with Digital Health, Core Facilities and study sites to ensure study data, milestones, and timelines are properly updated and aligned with institutional and sponsor requirements.
• Schedules remote or in-person visits, to assist with post approval monitoring and quality improvement activities.
• May assist with the supervision, training, and evaluation of the work of other staff and/or student workers.
• Supports the feasibility and intake process by performing early assessment and intake of clinical research; reviews study requirements, operational needs, study population, timelines, resource availability, and regulatory and compliance readiness.
• Coordinates with investigators, sponsors, research teams, finance, regulatory, ancillary departments, biostatisticians and core facilities to determine whether a study is practical, aligned with institutional capabilities, and appropriate to move forward into start-up.

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
• 12-15 days of annual paid holidays
• Up to eight hours of paid sick leave and at least eight hours of paid vacation each month
• Automatic enrollment in the Teacher Retirement System of Texas
• Free exercise programs and release time
• All employees have access to free LinkedIn Learning training, webinars, and limited financial support to attend conferences, workshops, and more
• Educational release time and tuition assistance for completing a degree while a Texas A&M employee

What This Job Offers

• Job Type: Full-time
• Career Level: Senior