Research Compliance Specialist

UTHealth Houston•Houston, TX

1d•Hybrid

About The Position

The Research Compliance Specialist supports research compliance operations and helps ensure research activities comply with good clinical practice guidelines. The role provides regulatory support to investigators and research staff, including assistance with Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, Data Safety Monitoring Board (DSMB) matters, and clinical trial registration. It also supports the human subjects protection quality improvement program through post-approval monitoring and education. The position coordinates research education programs on regulatory issues, including good clinical practices, human research protections, and new investigator training. It may help conduct investigations into research noncompliance allegations and assist with developing research compliance policies and procedures. This is a hybrid role, with most work performed remotely and one required in-person day per week. Employees must permanently reside and work in Texas.

Requirements

Bachelor’s degree in a basic science.
At least three years of clinical trial regulatory affairs or clinical trial coordination experience.
Comprehensive knowledge of Good Clinical Practices, coverage analysis, and IND, IDE, and IRB regulations.
One of the following certifications is required: Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS); Association of Clinical Research Professionals Certified Professional (ACRP-CP); or Certified Clinical Research Coordinator (CCRC) from the Association of Clinical Research Professionals (ACRP).
Must permanently reside and work in Texas.

Nice To Haves

Certified IRB Professional (CIP) certification from Public Responsibility in Medicine and Research (PRIM&R).

Responsibilities

Assist the Executive Director in executing the human subjects quality improvement program for regulatory compliance, including IRB post-approval monitoring and education.
Assist researchers and research staff with regulatory matters, including preparing and submitting IND and IDE applications.
Help identify clinical trials that must be registered and assist researchers with trial registration, results updates, and resolution of record problems.
Coordinate research education programs on regulatory issues, including good clinical practices, human research protections, and new investigator training.
Help conduct for-cause investigations into research noncompliance allegations.
Assist in developing research compliance policies and procedures.
Perform other duties as assigned.

Benefits

100% paid medical premiums for full-time employees.
Generous time off, including holidays, a preventative leave day, vacation, and sick time—approximately 37–38 days per year.
Increasing vacation accrual with length of service.
Longevity pay through 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, including entertainment, car rentals, and cell phones.
Resources for child and elder care.