Clinical Research Regulatory Specialist

The University of Texas Medical Branch; Galveston (TX); On-site; USD 85,000 - 110,000; Full time

Job summary

UTMB Health in Galveston, TX seeks a Regulatory QA Specialist to provide regulatory expertise to faculty, principal investigators, and study teams.

You will ensure compliance with GCP, IRB policies, sponsor and UTMB guidelines, identify deviations, and support development of policies, SOPs, and training programs. Strong CFR, HIPAA, and ethics knowledge preferred; Bachelor’s degree and 5+ years of related experience required.

Qualifications

• Bachelor’s degree or equivalent and 5 years of related experience.
• Two (2) years of clinical monitoring experience or Three (3) years’ experience in developing training programs
• Clinical Research Associate (CRA) Certification
• Understands and can apply knowledge of clinical trial designs to trial execution
• Experience in the medical/healthcare industry

Responsibilities

• Provide analytical, technical, and professional support to the Office of Research Integrity and Regulatory Affairs. (RIRA).
• Support IRB processing, IND/IDE submission, and Clinicaltrials.gov listing and reporting.
• Serve as a regulatory expert regarding compliance with GCP and CFR.
• Provide analysis of study processes to identify opportunities to enhance compliance and efficiency.
• Troubleshoot clinical trials and activities.
• Manage and maintain databases (quality systems and trainings).
• May support IT in regulatory data initiatives and interfaces.
• Prepare annual reports and quality trending reports.

Skills

GCP knowledge

Regulatory compliance

HIPAA knowledge

Trial design

Clinical monitoring

Education

Bachelor’s degree or equivalent

Job description

UTMB Health in Galveston, TX seeks a Regulatory QA Specialist to provide regulatory expertise to faculty, principal investigators, and study teams.

You will ensure compliance with GCP, IRB policies, sponsor and UTMB guidelines, identify deviations, and support development of policies, SOPs, and training programs. Strong CFR, HIPAA, and ethics knowledge preferred; Bachelor’s degree and 5+ years of related experience required.