Senior Regulatory Associate, Cancer Center Trials

University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 85,000 - 110,000; Full time

Job summary

University of Texas Southwestern Medical Center is seeking a Senior Regulatory Associate for the Simmons Comprehensive Cancer Center Education and Training Office in Dallas. You will support regulatory reviews for a Disease Oriented Team’s clinical trials under the Cancer Center leadership and mentor junior staff.

Responsibilities include preparing IRB/IACUC submissions, maintaining regulatory documents, and ensuring compliance with HIPAA and regulatory standards.

Qualifications

• Bachelor's degree required.
• 3 years of related experience in review/oversight of scientific research projects.
• Experience with IRB and IACUC processes is required or beneficial.
• CERTIFIED PROFESSIONAL or prior IRB service is a plus.
• HIPAA/compliance training and information security awareness preferred.

Responsibilities

• Collaborates with IRB, IACUC, and other regulatory entities to provide protocol review services.
• Prepares, submits, and revises IRB/IACUC applications, renewals, and audits.
• Maintains regulatory documents and study files (electronic and paper).
• Trains staff on IRB, IACUC, HIPAA compliance and security protocols.
• Suggests policy improvements to enhance program compliance.
• Ensures operations comply with applicable laws and internal controls.
• Keeps up with regulatory literature and training to stay current.
• Performs other duties as assigned.

Skills

Regulatory oversight

IRB coordination

IACUC knowledge

Clinical research

Policy compliance

Education

Bachelor's Degree

Advanced degree (preferred)

Job description

University of Texas Southwestern Medical Center is seeking a Senior Regulatory Associate for the Simmons Comprehensive Cancer Center Education and Training Office in Dallas. You will support regulatory reviews for a Disease Oriented Team’s clinical trials under the Cancer Center leadership and mentor junior staff.

Responsibilities include preparing IRB/IACUC submissions, maintaining regulatory documents, and ensuring compliance with HIPAA and regulatory standards.