Regulatory Monitoring Analyst IWHY UT SOUTHWESTERN? 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!
JOB SUMMARY:
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.
BENEFITS:
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 EmployerEXPERIENCE AND EDUCATION: Required 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 Experience 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.
Licenses and Certifications:
Certifications in healthcare, compliance, or regulatory clinical trials is preferred.
JOB DUTIES:
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.
SECURITY AND EEO STATEMENT:
Security This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information. To the extent this position requires the holder to research, work on, or have access to critical infrastructure as defined in Section 117.001(2) of the Texas Business and Commerce Code, the ability to maintain the security or integrity of the critical infrastructure is a minimum qualification to be hired and to continue to be employed in the position. EEO UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.
PRIMARY LOCATION:
Texas-Dallas-5323 Harry Hines BlvdWORK LOCATIONS: 5323 Harry Hines Blvd Dallas 75390JOB: Professional & ExecutiveORGANIZATION: 223003 - Reg Sppt and MonitoringSCHEDULE: Full-timeSHIFT: Day JobEMPLOYEE STATUS: RegularJOB TYPE: Standard
