Human Research Protections Analyst

Hyperion Biotechnology; Falls Church (VA); On-site; USD 90,000 - 120,000; Full time

Job summary

Hyperion Biotechnology is seeking a Research Compliance Analyst to support the HRPP and protect human subjects involved in research. The role covers regulatory analysis, program support, site assessments, and technical writing, with emphasis on the Common Rule (45 CFR Part 46).

You will use AI tools to prepare reports and presentations. Ideal candidates have 2+ years in human subjects research and strong Excel/presentation skills, plus willingness to travel up to four times annually and possess

Qualifications

• Bachelor's degree in biomedical, socio-behavioral, scientific, health, research, or other relevant field.
• At least 2 years of professional experience working directly with human subjects research.
• Demonstrated working knowledge of regulations and ethical requirements governing human subjects research, with emphasis on the Common Rule (45 CFR Part 46).
• Ability to travel domestically and internationally up to four times per year.
• Current passport or ability to obtain one.
• Experience with generative AI or AI-enabled tools to support professional work.
• Proficiency with Microsoft Excel and presentation software.

Responsibilities

• Review IRB minutes, research protocols, program documentation, and other materials to evaluate compliance with applicable Federal, DoD, Navy, and human subjects research requirements.
• Serve as a point of contact for assigned organizations and provide guidance and program support related to human research protections.
• Assist HRPP staff, IRB members, HRPOs, investigators, and other stakeholders with questions concerning human subjects research requirements.
• Participate in site assessments and assist visits involving Navy commands and research sites.
• Interview research and human research protection personnel and review HRPP, IRB, investigator, and research program records.
• Evaluate findings objectively and contribute to written assessment reports, summaries, presentations, and recommendations.
• Assist with development and implementation of human subject protection policies, procedures, guidance, training, and quality-improvement activities.
• Review institutional HRPP instructions, policies, procedures, assurances, IRB rosters, agreements, and related documentation.
• Analyze compliance and program information to identify trends, recurring issues, and opportunities for improvement.
• Prepare professional written reports and executive-level presentations explaining findings and recommendations.
• Use Excel and other analytical tools to organize, analyze, and visualize program information.
• Use generative AI and other AI-enabled tools to assist with development of presentations, graphics, analyses, summaries, reports, and literature or regulatory research.

Skills

Regulatory compliance knowledge

IRB coordination experience

AI-enabled tools usage

Microsoft Excel

Presentation software

Education

Bachelor's degree in biomedical or related field

Tools

Power BI

Tableau

Job description

Hyperion Biotechnology is seeking a Research Compliance Analyst to support the HRPP and protect human subjects involved in research. The role covers regulatory analysis, program support, site assessments, and technical writing, with emphasis on the Common Rule (45 CFR Part 46).

You will use AI tools to prepare reports and presentations. Ideal candidates have 2+ years in human subjects research and strong Excel/presentation skills, plus willingness to travel up to four times annually and possess