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

UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:

• 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!

• Education:
  
  Bachelor's Degree in science, nursing, public health, biology, pharmacy, healthcare administration, or related areas.
• Experience:
  
  2 years of professional experience in human subject research and/or research regulatory affairs/compliance is required.
• Preferred:
  Previous experience with clinical trials monitoring, human subjects research in an academic medical center, supporting clinical trials.gov study records, or working with an IRB is a plus.
• Licenses and
  
  Certifications:
  
  Certifications in healthcare, compliance, or regulatory clinical trials is preferred.

• 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 Clinical Trials.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 Clinical Trials.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.
• Coll…