Regulatory Research Specialist - GCP & IRB Expert

Utmb; Galveston (TX); Hybrid; USD 85,000 - 110,000; Full time

Job summary

UTMB Health seeks a Research Regulatory Specialist within the Institute for Translational Science. The role provides regulatory expertise to faculty, PIs, and staff to ensure trials comply with GCP, IRB policies, and sponsor guidelines.

You will identify deviations, escalate issues, and help manage regulatory data and training programs. Under the Director of Research Integrity and Regulatory Affairs, you will contribute to policy development, audits, and quality improvement initiatives,

Qualifications

• Bachelor’s degree or equivalent and 5 years of related experience.
• Preferred: CRA Certification.
• Two years of clinical monitoring or three years in developing training programs.

Responsibilities

• Provide regulatory expertise to faculty, PIs, and research personnel per GCP, IRB policies, sponsor and UTMB guidelines.
• Identify and escalate protocol deviations, noncompliance, and data discrepancies to ensure compliance.
• Support regulatory compliance activities including IRB processing, IND/IDE submissions, and Clinicaltrials.gov reporting.
• Serve as regulatory expert for compliance with GCP and CFR regulations in clinical research.
• Develop and maintain regulatory policies and deliver timely service to customers.

Skills

Clinical monitoring

Training program development

Regulatory knowledge

Education

Bachelor's degree

Tools

CRA Certification

Job description

UTMB Health seeks a Research Regulatory Specialist within the Institute for Translational Science. The role provides regulatory expertise to faculty, PIs, and staff to ensure trials comply with GCP, IRB policies, and sponsor guidelines.

You will identify deviations, escalate issues, and help manage regulatory data and training programs. Under the Director of Research Integrity and Regulatory Affairs, you will contribute to policy development, audits, and quality improvement initiatives,