Senior Regulatory Analyst, IRB & Human Research Protection

UT Southwestern; Dallas (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

UT Southwestern is seeking a Senior Regulatory Analyst for the Human Research Protection IRB to collaborate with investigators on proposals for human clinical trials and animal research. You will perform protocol pre-reviews and provide regulatory consultation to investigators to enhance IRB/IACUC approval likelihood.

Strong knowledge of DHHS, FDA, HIPAA, and related policies is essential, along with the ability to train staff and maintain documentation compliant with federal requirements.

Qualifications

• Bachelor’s degree required; Master’s degree preferred.
• Experience in regulatory oversight of human or animal research.
• Experience with IRB/IACUC processes is highly valued.

Responsibilities

• Provide expert-level knowledge of federal, state, and institutional regulations affecting human/animal research.
• Review complex research documents for ethical and regulatory issues.
• Guide researchers and staff on protocol submissions and regulatory reviews.
• Document decision processes in reviewer checklists and correspondence.
• Develop and maintain relationships with internal/external stakeholders.

Skills

Regulatory knowledge

IRB/IACUC familiarity

Clinical research environment

Education

Bachelor's Degree in related field

Master's Degree in related field preferred

Tools

CPIA or CIP certification

Job description

UT Southwestern is seeking a Senior Regulatory Analyst for the Human Research Protection IRB to collaborate with investigators on proposals for human clinical trials and animal research. You will perform protocol pre-reviews and provide regulatory consultation to investigators to enhance IRB/IACUC approval likelihood.

Strong knowledge of DHHS, FDA, HIPAA, and related policies is essential, along with the ability to train staff and maintain documentation compliant with federal requirements.