Research Compliance Specialist (Part Time)

UTHealth Houston•Houston, TX

1d•Onsite

About The Position

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.

Requirements

Comprehensive knowledge of Good Clinical Practices
Coverage Analysis
IND, IDE and IRB regulations
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
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.
Employees must permanently reside and work in the State of Texas.

Nice To Haves

Certified IRB Professional (CIP) by Public Responsibility in Medicine and Research (PRIM&R) preferred

Responsibilities

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.

Benefits

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)
Awesome retirement/pension plan
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