Regulatory Monitoring Analyst I, Reg Support and Monitoring

UT Southwestern Medical Center • Dallas, TX

1d • Onsite

About The Position

Works under moderate supervision to support regulatory monitoring reviews of various Research Administration functions. Provides support to the Regulatory Support Office for sponsor investigator and ClinicalTrials.gov services. Collaborates with team members to assess compliance with internal controls, training requirements, policies, procedures, and applicable regulatory requirements.

Requirements

• Bachelor's Degree in science, nursing, public health, biology, pharmacy, healthcare administration, or related areas.
• 2 years of professional experience in human subject research and/or research regulatory affairs/compliance is required.

Nice To Haves

• Previous experience with clinical trials monitoring, human subjects research in an academic medical center, supporting clinicaltrials.gov study records, or working with an IRB is a plus.
• Certifications in healthcare, compliance, or regulatory clinical trials is preferred.

Responsibilities

• Participates in routine, non-for-cause post approval regulatory and quality assurance monitoring reviews of Research Administration functions; prepares monitoring reports, supports findings, and contributes to corrective action recommendations.
• Assists in providing ClinicalTrials.gov support for human research studies across UTSW and affiliated entities, including data collection, record maintenance, results reporting, and resolution of problem records.
• Assists with ongoing tracking, notifications, and follow up for ClinicalTrials.gov records, annual record verification, results reporting and verification of responsible party determinations.
• Supports Sponsor Investigator regulatory activities, including consultations, submissions, tracking of active INDs, IDEs, and sINDs, and issuance of annual report reminders and regulatory notifications.
• Assists management with development and maintenance of monitoring plans, regulatory tools, metrics, reports, and sampling methodologies to support effective post monitoring and regulatory oversight.
• Coordinates onboarding activities for monitoring and regulatory staff, including access requests and first day/first week task planning.
• Provides administrative and operational support for monitoring activities, including scheduling, document control, template preparation, SOP updates, and shared file management.
• Collaborates with Export Control, Research Security, Conflict of Interest, IRB, and other Research Administration offices to support compliance reviews and institutional research oversight.
• Maintains current knowledge of federal, state, local, and institutional research regulations and guidance through participation in training and educational activities.
• Participates in training and educational activities to maintain and enhance knowledge of research regulations, ICH-GCP, ALCOA principles, IND/IDE processes, and ClinicalTrials.gov requirements.
• Collaborates with IRB, regulatory, ClinicalTrials.gov, and other institutional regulatory partners to support effective education of research staff and investigators on regulatory compliance and ethical research conduct.
• Assist investigators to understand and comply with the ethical guidelines and regulatory requirements for research.
• Performs 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-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

What This Job Offers

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