Regulatory Monitoring Analyst II, Regulatory Support and Monitoring

UT Southwestern Medical Center•Dallas, TX

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 the development and maintenance of Quality Assurance and Monitoring (QAM) processes and tools, including SOPs, checklists, and REDCap instruments, and participates in training to ensure compliance with institutional and regulatory requirements. The role conducts assurance and effectiveness reviews, reviews and supports ClinicalTrials.gov submissions, advises sponsor-investigators on regulatory activities, evaluates research compliance controls, and supports investigations and audits. It creates monitoring reports, collaborates with research administration and institutional compliance partners, develops and delivers training, and helps investigators understand ethical guidelines and regulatory requirements.

Requirements

Bachelor's degree in science, nursing, public health, biology, pharmacy, healthcare administration, or a related area.
At least 3 years of professional experience in research compliance.
Knowledge of federal regulations governing research.
Project management skills, including establishing goals and objectives while meeting deadlines.
Excellent written, verbal, and interpersonal communication skills, and ability to provide technical assistance and consultation and work effectively with staff, faculty, and scientists at all levels.
Ability to evaluate and analyze data to determine compliance with rules and regulations.
Ability to review, recommend, develop, and implement policies.
Computer proficiency and comfort with electronic technology for data management.

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 risk-analysis-based work plans.
Certification or completed coursework in clinical research monitoring or healthcare compliance, including Certified in Healthcare Research Compliance (CHRC).

Responsibilities

Conduct complex assurance and effectiveness reviews of compliance activities according to applicable standards, metrics, compliance plans, and departmental policies.
Establish goals, objectives, timelines, and quality measures for team work and deliverables.
Review ClinicalTrials.gov submissions and provide feedback and support for human research studies, including data collection, record maintenance, results reporting, and resolution of problem records.
Track ClinicalTrials.gov records; provide notifications and follow-up; conduct annual record verification and results reporting; 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 and provide guidance.
Evaluate the effectiveness of research regulatory and compliance controls and adherence to university research policies and procedures; develop metrics to evaluate controls and operational areas.
Work with Research Administration leadership on for-cause investigations, alleged policy breaches, research misconduct, or other non-compliance to determine causes, extent of loss, and prevention mechanisms.
Serve as a lead monitor for not-for-cause post-approval monitoring of UTSW IRB-approved studies and sponsor-investigator monitoring services; assist study teams preparing for external agency audits and support requested investigations.
Assist Research Administration in responding to findings from 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 regarding regulatory or procedural deficiencies that may affect research compliance.
Collaborate 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 integrate operational activities with institutional compliance activities.
Stay current on developments in research administration and regulatory compliance and coordinate dissemination of information with Research Administration areas.
Coordinate and maintain policies, procedures, and compliance-related education and training materials with Research Administration areas.
Develop and conduct training sessions on compliance-related topics for research administrative areas as needed.
Collaborate with IRB, regulatory, ClinicalTrials.gov, and other institutional regulatory partners to educate research staff and investigators about regulatory compliance and ethical research conduct.
Evaluate the need for innovative monitoring visit types, recommend them, and assist with or independently develop new visit 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
Wellness programs
Tuition reimbursement
Public Service Loan Forgiveness (PSLF) qualified employer
Paid holidays
On-site childcare