Senior Regulatory and Compliance Specialist - Orthopedic ResearchLocation: Texas Medical Center-Houston, TexasCategory: ResearchMcGovern Medical School at UTHealth HoustonRequisition #: 240000T1What 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 wont 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:Creates and implements SOPs for Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) studies, conducts internal audits, and provides training to laboratory staff and trainees to qualify the facility. Provides regulatory support for researchers including Investigational New Drug (IND) and Investigational Device Exception (IDE) submissions, maintaining regulatory binders, Data Safety Monitoring Board (DSMB) and clinical trials registration.Position Key Accountabilities:
Assists researchers in developing methods, SOPs, and protocols.
Assists in qualification of cGMP facilities and analytical instrumentation in the Center for Molecular Imaging (CMI).
Conducts quality assurance evaluation of activities in the CMI.
Maintains chain of custody documentation for controlled substances, batch release agents, and reference standards, human DNA samples, etc.
Ensures laboratory adherence to regulatory guidelines (GLP, FDA, etc.) and conducts internal audits.
Coordinates project timelines to coincide with regulatory and sponsor deadlines.
Assists researchers in Institutional Research Board (IRB) and Food and Drug Administration (FDA) submissions and coordinates with clinical partners across the Texas Medical Center (TMC).
Maintains regulatory binders and communicates with the FDA.
Assists in educational programs related to regulatory issues, including developing training programs, conducting training, and developing training modules.
Assists in grant and proposal writing.
Other duties as assigned.
Certification/Skills:Certified Clinical Research Coordinator (CCRC) or Certified IRB Professional (CIP) preferred; and a comprehensive knowledge of GLP, IND/IDE, and IRB regulations.Minimum Education:Bachelor’s degree in a basic science; Master’s degree preferred. May substitute required education with equivalent years of additional experience beyond the minimum experience requirement.Minimum Experience:Five years of regulatory affairs 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 job class may contain positions that are security sensitive and thereby subject to the provisions of Texas Education Code § 51.215Residency Requirement:Employees must permanently reside and work in the State of Texas.If you are looking for a great healthcare career in Houston, visithttp://go.uth.edu/careers!University of Texas Health Science Center at Houston (UTHealth)Established in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth) is Houston’s Health University and Texas’ resource for health care education, innovation, scientific discovery and excellence in patient care. The most comprehensive academic health center in the UT System and the U.S. Gulf Coast region, UTHealth Houston is home to schools of biomedical informatics, biomedical sciences, dentistry, nursing and public health and the John P. and Kathrine G. McGovern Medical School. UTHealth Houston includes The University of Texas Harris County Psychiatric Center, as well as the growing clinical practices UT Physicians, UT Dentists and UT Health Services. The university’s primary teaching hospitals are Memorial Hermann-Texas Medical Center, Children’s Memorial Hermann Hospital and Harris Health Lyndon B. Johnson Hospital.UTHealth BenefitsUTHealth Houston offers a comprehensive and competitive benefits package. For more information on our benefits programs please refer to the UTHealth Houston Office of Benefits Website.https://www.uth.edu/benefits/Equal Employment Opportunity StatementUTHealth Houston is committed to providing equal opportunity in all employment-related activities without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, gender identity or expression, veteran status or any other basis prohibited by law or university policy. Reasonable accommodation, based on disability or religious observances, will be considered in accordance with applicable law and UTHealth Houston policy. The University maintains affirmative action programs with respect to women, minorities, individuals with disabilities, and eligible veterans in accordance with applicable law.UTHealthHoustonhas adopted a policy consistent with CMS regulations to protect our patients and university community from exposure to COVID-19. This policy affects all employees, residents, fellows, students, contractors, new hires, visiting scholars program participants, adjunct faculty, and volunteers who work, train, or collaborate at the John S. Dunn Behavioral Science Center.In addition, all UTHealthHoustonemployees who are assigned to work at a location that is subject to the affiliated partner’s hospital, clinical offices, or agency are required to abide by UTHealth’sHoustonrules and regulations, as well as the affiliate’s rules and regulations, including COVID-19 vaccination and safety requirements.Work location is based on the needs of the department and may be adjusted.