Regulatory Monitoring Analyst II - IRB & Trials Oversight

University of Texas Southwestern Medical Center; Dallas (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

PPO medical plan

No copay for preventive care

Paid Time Off

Retirement Programs (TRS)

Paid Parental Leave

Wellness programs

Tuition Reimbursement

Public Service Loan Forgiveness (PSLF)

Job summary

UT Southwestern Medical Center in Dallas seeks a Regulatory Monitoring Professional to manage complex reviews of research compliance, IRB-related activities, and sponsor investigations. You will develop SOPs, checklists, and REDCap tools to support quality assurances.

You will lead not-for-cause post-approval monitoring, assist with external audits, and provide guidance to sponsor-investigators on regulatory submissions, with a focus on protecting human research participants and ensuring

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 is required.
• Knowledge of federal regulations governing research is required.

Responsibilities

• Conducts complex assurance/effectiveness reviews of compliance activities in accordance with standards and policies.
• Review ClinicalTrials.gov submissions and provide feedback for human research studies across UTSW and affiliates.
• Tracking, notifications, and follow up for ClinicalTrials.gov records and results reporting.
• Provides guidance to Sponsor Investigator for regulatory activities including INDs, IDEs, and sINDs, and annual report reminders.
• Evaluates effectiveness of research regulatory controls and ensures adherence to university policies.
• Assists with for-cause investigations, alleged breaches of policy, and research misconduct investigations.
• Serves as lead monitor on post-approval monitoring of IRB-approved studies and sponsor-investigator monitoring services.
• Collaborates with Export Control, Research Security and Conflict of Interest offices as needed.
• Creates monitoring reports with supporting evidence and defends findings.
• Identifies studies with past non-compliance and helps select upcoming study assignments.
• Maintains relationships with Research Administration and compliance personnel to achieve objectives.
• Keeps current with developments in research administration and compliance.
• Coordinates and maintains policies and training materials; develops training on compliance topics.
• Collaborates with IRB and regulatory partners to educate staff and investigators on ethics and regulatory requirements.
• Evaluates need for new monitoring visit types and assists in developing them.
• Performs other duties as assigned.

Education

Bachelor's Degree in science, nursing, public health, biology, pharmacy, healthcare administration, or related area

3 years of professional experience in research compliance

Knowledge of federal regulations governing research

Job description

UT Southwestern Medical Center in Dallas seeks a Regulatory Monitoring Professional to manage complex reviews of research compliance, IRB-related activities, and sponsor investigations. You will develop SOPs, checklists, and REDCap tools to support quality assurances.

You will lead not-for-cause post-approval monitoring, assist with external audits, and provide guidance to sponsor-investigators on regulatory submissions, with a focus on protecting human research participants and ensuring