Clinical Trial Support - Regulatory Affairs Administrator (Clinical Trials)

Location: College Station, Texas, United States

Salary: $114,000–$125,000 annually; the proposed minimum salary is $9,500 monthly.

Company

Texas A&M University provides centralized clinical research support through its Clinical Research Support Office within the Division of Research.

What you will do

• Develop, implement, and manage regulatory strategies, processes, resources, and communications for clinical research.
• Support investigators with clinical research protocols, submission packets, regulatory documents, and product approval materials.
• Communicate with regulatory agencies about investigational drugs, devices, biological products, and applicable requirements.
• Maintain audit-ready files, regulatory databases, study records, milestones, and timelines from feasibility through closeout.
• Develop and deliver regulatory training through seminars, presentations, newsletters, electronic communications, and updated templates.
• Coordinate feasibility assessments with investigators, sponsors, finance, regulatory teams, ancillary departments, biostatisticians, and core facilities.

Requirements

• Bachelor’s degree in an applicable field or an equivalent combination of education and experience.
• At least six years of experience in clinical trials, research, or compliance, including regulatory support, agreements, cost coverage analyses, grants, contracts, budgets, and billing.
• Knowledge of research contracts, clinical trial costs, coverage analysis, data management, electronic submission systems, and human research protection databases.
• Strong written and verbal communication, public speaking, presentation, analytical, negotiation, collaboration, and multitasking skills.
• Ability to manage multiple projects independently, including timelines, reviews, and deliverables.
• Employment is contingent on credential verification and completion of a criminal history check; all positions are security-sensitive.

Nice to have

• Master’s degree in education, business, research, science-related, or legal studies.
• CIP, CCRC, CCRP, CTM, or RAC certification, or a Juris Doctorate.
• Experience with FDA commercialization pathways, including INDs, IDEs, PMAs, 510(k)s, documentation packages, and annual reports.
• Knowledge of biomedical and behavioral research, HIPAA, FDA, OHRP, international standards, and funding agency requirements.

Culture & Benefits

• Medical, prescription drug, dental, vision, life, AD&D, flexible spending, and long-term disability insurance, with employer contributions to health and basic life premiums.
• 12–15 days of annual paid holidays, monthly paid sick leave, and paid vacation.
• Automatic enrollment in the Teacher Retirement System of Texas.
• Free exercise programs, wellness resources, LinkedIn Learning, webinars, and limited conference and workshop support.
• Educational release time and tuition assistance for completing a degree while employed.