Role OverviewWorks under moderate supervision to support regulatory monitoring reviews of various Research Administration functions. Provides support to the Regulatory Support Office for sponsor investigator and ClinicalTrials.gov services. Collaborates with team members to assess compliance with internal controls, training requirements, policies, procedures, and applicable regulatory requirements.
What You Will Do
Participates in routine, non-for cause post approval regulatory and quality assurance monitoring reviews of Research Administration functions; prepares monitoring reports, supports findings, and contributes to corrective action recommendations. Assists in providing ClinicalTrials.gov support for human research studies across UTSW and affiliated entities.
Why It Might Be a Fit
Maintains current knowledge of federal, state, local, and institutional research regulations and guidance through participation in training and educational activities. Collaborates with IRB, regulatory, ClinicalTrials.gov, and other institutional regulatory partners to support effective education of research staff and investigators on regulatory compliance and ethical research conduct.
Requirements
- Bachelor's Degree in science, nursing, public health, biology, pharmacy, healthcare administration, or related areas.
- 2 years of professional experience in human subject research and/or research regulatory affairs/compliance is required.
- Certifications in healthcare, compliance, or regulatory clinical trials is preferred.
Benefits
- PPO medical plan
- 100% coverage for preventive healthcare-no copay
- Paid Time Off
- Retirement Programs through the Teacher Retirement System of Texas (TRS)
- Paid Parental Leave Benefit
- Wellness programs
- Tuition Reimbursement
- Public Service Loan Forgiveness (PSLF) Qualified Employer
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