Human Research Protections Specialist

Hyperion Biotechnology; Falls Church (VA); On-site; USD 70,000 - 95,000; Full time

Job summary

Hyperion Biotechnology is seeking a Research Compliance Analyst to support a Human Research Protection Program (HRPP) and activities protecting human subjects in research. The role blends regulatory analysis, program support, site assessments, technical writing, data analysis, and AI-enabled tools to enhance HRPP operations.

The successful candidate will review IRB minutes, protocols, and program documents for compliance, serve as a point of contact for organizations, and assist HRPP staff,

Qualifications

• Bachelor's degree in a biomedical, socio-behavioral, scientific, health, research, or related field.
• At least 2 years of professional experience working directly with human subjects research.
• Experience as regulatory compliance specialist, IRB administrator or coordinator, or similar.
• Demonstrated knowledge of the Common Rule (45 CFR Part 46).
• Ability to describe how human subjects protection requirements affected work.
• Strong written and verbal communication skills.
• Experience preparing reports, presentations, data summaries, or other professional products.
• Experience using generative AI or AI-enabled tools for professional work.
• Proficiency with Microsoft Excel and presentation software.
• Ability to travel domestically and internationally up to four times per year.
• Current passport or ability to obtain one.

Responsibilities

• Review IRB minutes, research protocols, program documentation to evaluate compliance with Federal, DoW, Navy, and human subjects rules.
• Serve as a point of contact for assigned organizations and provide HRPP guidance.
• Assist HRPP staff, IRB members, HRPOs, investigators, and research personnel with questions on requirements.
• Participate in site assessments and assist Navy-related visits.
• Interview HRPP personnel and review HRPP, IRB, investigator records.
• Evaluate findings and contribute to written assessment reports and recommendations.
• Assist development and implementation of HRPP policies, procedures, training, and quality-improvement activities.
• Review HRPP instructions, policies, procedures, and related documentation.
• Analyze program information to identify trends and opportunities for improvement.
• Prepare professional written reports and executive presentations explaining findings and recommendations.
• Use Excel and other analytical tools to organize and visualize data.
• Use generative AI to assist with presentations, analyses, summaries, and regulatory research.
• Identify new processes and training needs for HRPPs.
• Maintain knowledge of regulations applicable to human subjects research.

Skills

Regulatory compliance

IRB administration

Research administration

Communication skills

Generative AI

Education

Bachelor's degree

Tools

Microsoft Excel

PowerPoint

Power BI

Tableau

Job description

Hyperion Biotechnology is seeking a Research Compliance Analyst to support a Human Research Protection Program (HRPP) and activities protecting human subjects in research. The role blends regulatory analysis, program support, site assessments, technical writing, data analysis, and AI-enabled tools to enhance HRPP operations.

The successful candidate will review IRB minutes, protocols, and program documents for compliance, serve as a point of contact for organizations, and assist HRPP staff,