Clinical Trial Support – Regulatory Affairs Administrator

About the role

The Clinical Research Support Office at Texas A&M University seeks a Regulatory Affairs Administrator to serve as a subject‑matter expert in clinical trial operations. The role involves developing regulatory strategies, providing guidance, and preparing submissions to ensure compliance throughout the research lifecycle.

Key responsibilities

• Develop and implement regulatory strategies for human participant studies.
• Prepare, review, and submit regulatory documents and communications to agencies.
• Collaborate with investigators, IRB staff, sponsors, and internal teams to facilitate approvals.
• Manage research contracts, coverage analyses, budgets, and billing related to clinical trials.
• Maintain electronic submission systems and databases for human research protections.

Required profile

• Bachelor’s degree in a relevant field or equivalent experience.
• At least six years of experience in clinical trials, research compliance, or related regulatory support.
• Strong understanding of research contracts, trial costs, and data management.
• Excellent written and verbal communication, public‑speaking, and negotiation abilities.
• Ability to multitask, work independently, and collaborate across diverse stakeholder groups.

Required skills

• Knowledge of electronic submission systems and databases used for human research protection.