Regulatory Monitoring Analyst II, Regulatory and Monitoring

With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report , we invest in you with opportunities for career growth and development to align with your future goals.

Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!

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 QAM processes and tools, including SOPs, checklists, and REDCap instruments, and participates in training to ensure compliance with institutional and regulatory requirements.

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100% coverage for preventive healthcare-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

Learn more about these and other UTSW employee benefits!

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

• 3 years of professional experience in research compliance.

Knowledge of federal regulations governing research required.

• Previous experience as a Clinical Research Associate (CRA) is preferred.
• Prefer experience at an academic medical center leading multi-faceted project teams and developing and successfully implementing work plans based on risk-analysis.

Certification/coursework completion in clinical research monitoring or healthcare compliance is preferred, including Certified in Healthcare Research Compliance (CHRC).

• Conducts complex assurance/effectiveness reviews of compliance activities in accordance with appropriate standards, metrics, established compliance plan(s) and prescribed departmental/unit/program policies. Establishes goals, objectives, timelines and quality measures for the team‿s work and deliverables.
• Review Clinical Trials.gov submissions and provide feedback and support for human research studies across UTSW and affiliated entities, including data collection, record maintenance, results reporting, and resolution of problem records.
• Tracking, notifications, and follow up for Clinical Trials.gov records, annual record verification, results reporting and verification of responsible party determinations.
• Provides guidance to Sponsor Investigator for their regulatory activities, including consultations, submissions, tracking of active INDs, IDEs, and sINDs, and issuance of annual report reminders and regulatory notifications. This includes reviewing materials prior to submission to the FDA and providing guidance.
• Evaluates effectiveness of research regulatory/compliance controls used by reviewed department/unit/program, as well as adherence with all applicable university research policies and procedures. Develops metrics within respective areas of Research Administration for evaluating effectiveness of controls and operational areas.
• Works with respective areas of Research Administration Leadership team to assist with for-cause investigations, alleged breaches of policy, research misconduct or other acts of non-compliance to determine cause, extent of loss and mechanisms for prevention.
• Serves as a lead monitor on not-for-cause post-approval monitoring of UTSW IRB approved studies, sponsor-investigator monitoring services, assist study teams in preparation for external agency audit (FDA, Sponsor, etc.) support services and/or other requested investigations by the IRB or compliance department(s). Assists Research Administration in…