Research Compliance Specialist in Clinical Trials

Houston, TX, United States

Research Compliance Specialist in Clinical Trials Research Compliance Specialist in Clinical Trials

Location: Texas Medical Center-Houston, Texas

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Category: Research

UTHealth Houston General Administration

Requisition #: 230002MD

Position Summary:

UTHealth is looking for a Research Compliance Specialist who will assist with clinical research trials that often involve human subjects. This employee is responsible for regulatory support with investigators and research staff including Investigational New Drug (IND), Investigational Device Exception (IDE), Data Safety Monitoring Board (DSMB) and clinical trials registration. They will assist with the human subjects protection quality improvement program including post approval monitoring and education. You should have experience with working with Institutional Review Boards and clinical research trials in general.

This will be a full time position that is salaried and classified as exempt. You will be eligible for all UTHealth benefits including healthcare coverage paid for by the institution, and participation in a pension plan funded by the State of Texas. Time off for vacation and illness are also extended, as well as all State of Texas recognized holidays. Your office will be based out of our University Professional Building in the heart of the Texas Medical Center. Remote or hybrid schedules may be considered, but ideally you should be able to come in from time to time to assist.

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 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.

Certification/Skills:

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

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 § 51.215

Residency 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 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.

Equal Employment Opportunity Statement

UTHealth 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.

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