Research Regulatory Monitoring Analyst

UT Southwestern; Dallas (TX); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

PPO medical plan

Paid Time Off

Retirement Programs

Paid Parental Leave

Tuition Reimbursement

Job summary

UT Southwestern Medical Center in Dallas, Texas seeks a Regulatory Monitoring professional to manage and conduct regulatory reviews for Research Administration functions. The role supports IRB-approved studies, external audits, for-cause investigations, and sponsor-investigator monitoring.

The candidate will help develop SOPs and REDCap tools and assist training to ensure compliance with institutional and regulatory requirements.

Qualifications

• Bachelor’s degree in science, nursing, public health, biology, pharmacy, healthcare administration, or related area is required.
• 3 years of professional experience in research compliance.
• Preferred: Clinical Research Associate (CRA) experience.
• Academic medical center experience leading multi-faceted project teams is a plus.

Responsibilities

• Conducts complex assurance reviews of compliance activities.
• Reviews ClinicalTrials.gov submissions and supports human research studies.
• Tracks ClinicalTrials.gov records, annual verification and results reporting.
• Advises Sponsor Investigators on regulatory activities and submissions.
• Evaluates effectiveness of research regulatory controls and policies.
• Leads not-for-cause post-approval monitoring and supports audits.
• Coordinates with IRB, Export Control, and Conflict of Interest offices.
• Develops monitoring reports and trains staff on compliance.

Skills

Regulatory knowledge

CRA experience

Research compliance

Education requirements

Education

Bachelor's Degree (Science/Health)

Job description

UT Southwestern Medical Center in Dallas, Texas seeks a Regulatory Monitoring professional to manage and conduct regulatory reviews for Research Administration functions. The role supports IRB-approved studies, external audits, for-cause investigations, and sponsor-investigator monitoring.

The candidate will help develop SOPs and REDCap tools and assist training to ensure compliance with institutional and regulatory requirements.