Regulatory Monitoring Analyst II, Regulatory Support and Monitoring

UT Southwestern Medical Center • Dallas, TX

1d

About The Position

Works under minimal supervision to manage and conduct regulatory monitoring reviews of Research Administration functions. Performs complex monitoring, assurance, and administrative activities for IRB-approved human research studies. Supports external audits, for-cause investigations, and sponsor-investigator monitoring services. Contributes to development and maintenance of Quality Assurance Monitoring (QAM) processes and tools, including SOPs, checklists, and REDCap instruments, and participates in training to ensure compliance with institutional and regulatory requirements.

Requirements

• Bachelor's degree in science, nursing, public health, biology, pharmacy, healthcare administration, or a related area.
• Three years of professional experience in research compliance.
• Knowledge of federal regulations governing research.

Nice To Haves

• Previous experience as a Clinical Research Associate (CRA).
• Experience at an academic medical center leading multifaceted project teams and developing and successfully implementing work plans based on risk analysis.
• Certification or coursework completion in clinical research monitoring or healthcare compliance, including Certified in Healthcare Research Compliance (CHRC).

Responsibilities

• Conduct complex assurance and effectiveness reviews of compliance activities using applicable standards, metrics, compliance plans, and departmental policies; establish goals, objectives, timelines, and quality measures for team deliverables.
• Review ClinicalTrials.gov submissions and support human research studies across UT Southwestern and affiliated entities, including data collection, record maintenance, results reporting, and resolution of problem records.
• Track ClinicalTrials.gov records, issue notifications and follow up, perform annual record verification, support results reporting and verification, and verify responsible-party determinations.
• Guide sponsor-investigators on regulatory activities, including consultations, submissions, tracking active INDs, IDEs, and sINDs, annual-report reminders, and regulatory notifications; review materials before FDA submission.
• Evaluate research regulatory and compliance controls and adherence to university policies and procedures; develop metrics to assess control effectiveness and operational areas.
• Assist Research Administration leadership with for-cause investigations and alleged policy breaches, research misconduct, or other non-compliance to determine cause, extent of loss, and prevention mechanisms.
• Lead not-for-cause post-approval monitoring of UTSW IRB-approved studies and sponsor-investigator monitoring services; assist study teams with preparation for external agency audits and support other requested investigations.
• Assist Research Administration in responding to audit findings identified by Internal Audit and external agencies.
• Collaborate with Export Control, Research Security, and Conflict of Interest offices and conduct reviews referred or requested by Research Administration.
• Prepare monitoring reports with supporting evidence and defend findings and recommendations about regulatory or procedural deficiencies that may affect research compliance.
• Work with the direct supervisor and Regulatory Monitoring Analyst Senior to identify studies with past non-compliance or regulatory issues for assignments and monitoring visits.
• Maintain effective working relationships with Research Administration and compliance personnel to support assurance assignments and integration with institutional compliance activities.
• Stay current on research administration and regulatory compliance developments and coordinate dissemination of information with relevant Research Administration areas.
• Coordinate and maintain policies, procedures, compliance education, and training materials; develop and conduct training sessions as needed.
• Collaborate with IRB, regulatory, ClinicalTrials.gov, and other institutional partners to educate research staff and investigators on regulatory compliance and ethical research conduct.
• Evaluate the need for innovative monitoring visit types, recommend them, and assist with or independently develop new types as assigned.
• Assist investigators in understanding and complying with ethical guidelines and regulatory requirements for research.
• Perform other duties as assigned.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage.
• 100% coverage for preventive healthcare with no copay.
• Paid time off, available day one.
• Retirement programs through the Teacher Retirement System of Texas (TRS).
• Paid parental leave benefit.
• Wellness programs.
• Tuition reimbursement.
• Public Service Loan Forgiveness (PSLF) qualified employer.
• On-site childcare.
• Paid holidays.
• Merit increases.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level