Senior Regulatory Associate – Clinical Trials & IRB/IACUC

University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

PPO medical plan

100% coverage for preventive care

Paid Time Off

Retirement Programs TRS

Paid Parental Leave

Wellness programs

Tuition Reimbursement

Public Service Loan Forgiveness (PSLF)

Learn more about these benefits

Job summary

UT Southwestern Medical Center in Dallas, TX is seeking a Regulatory Associate Senior to support IRB/IACUC regulatory submissions for clinical trials. You will review protocols, draft consent forms, and manage regulatory documents to ensure compliance.

The role involves mentoring entry and mid-level staff, coordinating with investigators, and maintaining essential regulatory records for long-term storage. Regulatory experience in clinical research is highly preferred.

Qualifications

• Education: Bachelor's degree in a relevant field.
• Minimum 3 years of related experience in review, oversight, or performance management of scientific research projects.
• Experience with IRB or IACUC processes is strongly preferred.

Responsibilities

• Collaborates with IRB, IACUC, and other regulatory bodies to deliver efficient protocol review services.
• Prepares, submits, and revises all IRB or IACUC applications and renewals.
• Maintains regulatory documents, both electronic and paper, for audit readiness.
• Trains staff on IRB, IACUC, and HIPAA compliance and information security.
• Supports DOT clinical trials and other teams as needed.
• Reviews study protocols and provides regulatory guidance to investigators.

Skills

Regulatory knowledge

IRB/IACUC experience

Documentation management

Education

Bachelor's Degree

Job description

UT Southwestern Medical Center in Dallas, TX is seeking a Regulatory Associate Senior to support IRB/IACUC regulatory submissions for clinical trials. You will review protocols, draft consent forms, and manage regulatory documents to ensure compliance.

The role involves mentoring entry and mid-level staff, coordinating with investigators, and maintaining essential regulatory records for long-term storage. Regulatory experience in clinical research is highly preferred.