Senior Regulatory Analyst - IRB/IACUC & Research Compliance

UT Southwestern Medical Center; Dallas (TX); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

UT Southwestern Medical Center in Dallas seeks a detail-oriented research regulatory specialist to work with investigators and research personnel on developing and refining proposals for human clinical trials and animal studies.

You will perform protocol pre-review, advise on regulatory issues to improve IRB and IACUC approvals, and provide training on federal and institutional requirements across DHHS, FDA, HIPAA, and related policies.

Formación

• Bachelor's Degree in related field required.
• 5 years of related research experience with Bachelor's degree, or 3 years with Master's degree.
• Master's Degree strongly preferred.
• CPIA/CIP certification or extensive knowledge of research protections strongly preferred.

Responsabilidades

• Provide expert-level knowledge of federal regulations (DHHS, PHS, FDA, USDA, HIPAA) and institutional policies relevant to human/animal research.
• Review complex scientific documents to identify ethical and regulatory issues.
• Guide research committee staff and investigators on protocol submissions and regulatory review processes.
• Document decision-making processes in required checklists, databases, and correspondence.
• Educate faculty and staff on protocol review processes and distribute resource materials to improve protections for human/animal subjects.
• Develop and maintain relationships with internal/external departments and agencies involved in the research program.

Conocimientos

Regulatory knowledge

Research coordination

Federal regulations

Regulatory training

Educación

Bachelor's Degree in related field

Master's Degree in related science

Descripción del empleo

UT Southwestern Medical Center in Dallas seeks a detail-oriented research regulatory specialist to work with investigators and research personnel on developing and refining proposals for human clinical trials and animal studies.

You will perform protocol pre-review, advise on regulatory issues to improve IRB and IACUC approvals, and provide training on federal and institutional requirements across DHHS, FDA, HIPAA, and related policies.