Research Compliance Specialist (Part Time)

What we do here changes the world. UTHealth Houston is Texas’ resource for healthcare education, innovation, scientific discovery, and excellence in patient care.

Benefits

• 100% paid medical premiums for full-time employees
• Generous time off (holidays, preventative leave day, vacation, and sick time totaling around 37-38 days per year)
• Increased vacation accrual with longevity
• Longevity Pay (monthly payments after two years of service)
• Retirement/pension plan
• Free financial and legal counseling
• Free mental health counseling services
• Gym membership discounts and access to wellness programs
• Employee discounts (entertainment, car rentals, cell phones, etc.)
• Resources for child and elder care
• Additional employee work/life services

Responsibilities

• 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.
• 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.

Requirements

• Comprehensive knowledge of Good Clinical Practices
• Coverage Analysis
• IND, IDE, and IRB regulations

Qualifications

• Regulatory Affairs Certification (RAC) by Regulatory Affairs Professionals Society (RAPS) required, or
• Association Clinical Research Professional - Certified Professional (ACRP-CP) by Association of Clinical Research Professional (ACRP) required, or
• Certified Clinical Research Coordinator (CCRC) by Association of Clinical Research Professionals (ACRP) required
• Certified IRB Professional (CIP) by Public Responsibility in Medicine and Research (PRIM&R) preferred
• 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.

This position is security-sensitive pursuant to Texas Education Code 51.215 and Texas Government Code 411.094. Employees in this role may be required to maintain the security or integrity of critical infrastructure as defined in Texas Business and Commerce Code 117.001(2).

Employees must permanently reside and work in the State of Texas.