IRB & Research Compliance Lead (Senior Regulatory Analyst)

University of Texas Southwestern Medical Center; Dallas (TX); Presencial; USD 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare benefits

Paid time off

On-site childcare

Descripción de la vacante

UT Southwestern Medical Center in Dallas, TX, seeks a seasoned regulatory specialist to support the development and refinement of proposals for human clinical trials and animal research. You will perform thorough protocol pre-review before IRB/IACUC submission and provide technical consultation on regulatory, scientific, or policy issues affecting approvals.

Responsibilities include reviewing complex research documents for ethical and regulatory concerns, guiding investigators, and documenting

Formación

• Bachelor's degree in a related field is required.
• 5 years of related research experience with a Bachelor's degree or 3 years with a Master's degree.
• Preferred: Master's degree and IRB/IACUC experience.

Responsabilidades

• Provide expert-level knowledge of federal and state regulations (DHHS, PHS, FDA, USDA, HIPAA) and institutional policies
• Review complex scientific research documents for ethical and regulatory issues
• May approve protocol submissions eligible for expedited reviews
• Document decision making in required checklists and correspondence
• Provide guidance to researchers and staff on complex regulatory issues
• Assist with protocols submissions and regulatory review processes
• Develop and maintain working relationships with internal/external departments
• Develop goals and standards for research committee operations
• Ensure internal controls are effective and efficient
• Perform other duties as assigned

Conocimientos

Research experience

Regulatory knowledge

Communication skills

Educación

Bachelor's Degree in related field

Master's Degree in related field (preferred)

Descripción del empleo

UT Southwestern Medical Center in Dallas, TX, seeks a seasoned regulatory specialist to support the development and refinement of proposals for human clinical trials and animal research. You will perform thorough protocol pre-review before IRB/IACUC submission and provide technical consultation on regulatory, scientific, or policy issues affecting approvals.

Responsibilities include reviewing complex research documents for ethical and regulatory concerns, guiding investigators, and documenting