| Location | Houston, TX |
What we do here changes the world. UTHealth Houston is Texas' resource for healthcare education, innovation, scientific discovery, and excellence in patient care. That's where you come in.Once you join us you won''t want to leave. It's because we reward our team for the excellent service they provide. Our total rewards package includes the benefits you'd expect from a top healthcare organization (benefits, insurance, etc.), plus: 100% paid medical premiums for our full-time employees Generous time off (holidays, preventative leave day, both vacation and sick time - all of which equates to around 37-38 days per year) The longer you stay, the more vacation you'll accrue! Longevity Pay (Monthly payments after two years of service) Build your future with our awesome retirement/pension plan! We take care of our employees! As a world-renowned institution, our employees' wellbeing is important to us. We offer work/life services such as... Free financial and legal counseling Free mental health counseling services Gym membership discounts and access to wellness programs Other employee discounts including entertainment, car rentals, cell phones, etc. Resources for child and elder care Plus many more! Position Summary:Assists with regulatory support for investigators and research staff, including Investigational New Drug (IND), Investigational Device Exception (IDE), Data Safety Monitoring Board (DSMB), and clinical trials registration. Assists with the human subjects protection quality improvement program, including post-approval monitoring and education. Position Key Accountabilities:Assists the Executive Director in executing the human subjects quality improvement program for regulatory compliance, including IRB post-approval monitoring and education.Assists researchers and research staff in regulatory matters, including preparing and submitting the IND/IDE application. Assists with the institutional effort to meet FDAA clinical trials registration requirements by identifying clinical trials that need to be registered, assisting researchers with registration, updating results, and resolving problems with records.Coordinates the research education programs related to regulatory issues, including good clinical practices, human research protections, and new investigator training.Helps conduct for-cause investigations for research noncompliance allegations.Assists in developing policies and procedures for research compliance.Other duties as assigned. Certification/Skills:Comprehensive knowledge of Good Clinical PracticesCoverage AnalysisIND, IDE and IRB regulationsRegulatory Affairs Certification (RAC) by Regulatory Affairs Professionals Society (RAPS) required orAssociation Clinical Research Professional - Certified Professional (ACRP-CP) by Association of Clinical Research Professional (ACRP) required orCertified Clinical Research Coordinator (CCRC) by Association of Clinical Research Professionals (ACRP) requiredCertified IRB Professional (CIP) by Public Responsibility in Medicine and Research (PRIM&R) preferredMinimum Education:Bachelor's degree in a basic science. Minimum Experience:3 years of clinical trial regulatory affairs or clinical trial coordination experience Physical Requirements:Exerts up to 20 pounds of force occasionally and/or up to 10 pounds frequently and/or a negligible amount constantly to move objects.Security Sensitive:This position is a security-sensitive position pursuant to Texas Education Code §51.215 and Texas Government Code §411.094. To the extent that a position requires the holder to research, work on, or have access to critical infrastructure as defined in Texas Business and Commerce Code §117.001(2), the ability to maintain the security or integrity of the infrastructure is a minimum qualification to be hired for and to continue to be employed in that position. Personnel in such positions, and similarly situated state contractors, will be routinely reviewed to determine whether things such as criminal history or continuous connections to the government or political apparatus of a foreign adversary might prevent the applicant, employee, or contractor from being able to maintain the security or integrity of the infrastructure. A foreign adversary is a nation listed in 15 C.F.R. §791.4.Residency Requirement:Employees must permanently reside and work in the State of Texas.