Research Compliance Specialist (Multiple Vacancies)
Requisition #: 1900029C
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, and 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.
Regulatory Affairs Certification (RAC), Certified Clinical Research Professional (CCPR), Certified Clinical Research Coordinator (CCRC), or Certified IRB Professional (CIP) preferred; and a comprehensive knowledge of Good Clinical Practices, Coverage Analysis, IND, IDE and IRB regulations.
Bachelor’s degree in a basic science.
3 years of clinical trial regulatory affairs or clinical trial coordination experience
Exerts up to 20 pounds of force occasionally and/or up to 10 pounds frequently and/or a negligible amount constantly to move objects.
This job class may contain positions that are security sensitive and thereby subject to the provisions of Texas Education Code § 51.215
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 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 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 offers a comprehensive and competitive benefits package. For more information on our benefits programs please refer to the UTHealth Office of Benefits Website.
Equal Employment Opportunity Statement
UTHealth 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 policy. The University maintains affirmative action programs with respect to women, minorities, individuals with disabilities, and eligible veterans in accordance with applicable law.