Research Compliance Specialist
4 weeks ago
As a Research Compliance Coordinator at UT Health San Antonio, you will play a crucial role in ensuring the institution's compliance with regulations and policies regarding the use of human subjects, laboratory animals, or biologically infectious agents in research. This position requires a strong understanding of research regulatory and compliance knowledge, including standard IRB processes, data user, and data sharing.
Key Responsibilities
- Develop and implement compliance program components, including protocol and consent form review, record keeping, monthly and annual reporting, program evaluation, and other compliance issues that meet regulations and institutional policies and procedures.
- Provide education, advice, and assistance to compliance officials, regulatory committee members, investigators, research staff, and office staff to increase awareness of and compliance with human subject regulations.
- Evaluate processes and policies, and recommend changes to impact budgeting, controlling costs, planning, scheduling, and procedural change.
- Secure the cooperation of and coordinate with applicable institutional offices, affiliated institutions, or regulatory/accrediting agencies.
- Assist in preparation of information and reports for grant submissions, IRB protocol submissions, and/or budget analysis.
- Liaise with UTHSCSA Offices of Clinical Research, Institutional Review Board, Export Controls, Conflict of Interest, and Clinical Trials.
Requirements
- Requires significant research regulatory and compliance knowledge, including standard IRB processes, data user, and data sharing.
- Research-related work experience within a large multiple affiliate organization.
- Working knowledge of complex Federal, State, and Local research and HIPAA-related regulations.
- Ability to identify, analyze, and solve problems and work independently.
- Able to multitask and set priorities in a highly demanding environment.
- Excellent verbal, written, and interpersonal communications skills.
- Familiar with medical terminology.
- Proficient in using Microsoft Office (Word, Excel, PowerPoint) and databases.
- Working knowledge of IRB regulations, processes, and obtaining informed consent.
Education and Experience
- Bachelor's degree or equivalent is required.
- Three years of related experience is required.
About Us
UT Health San Antonio offers an excellent benefits package for its employees, including medical, dental, vision, life insurance, retirement plans, and time off.
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