Human Research Program Analyst at Hyperion Biotechnology, Inc. in Falls Church, VA, USA

Job description

• Hyperion Biotechnology is seeking a Research Compliance Analyst to support a Human Research Protection Program (HRPP) and activities involving the protection of human subjects participating in research.
• We are interested in candidates with practical experience working directly in the human research environment. This experience may come from regulatory compliance, an Institutional Review Board (IRB), research administration, human-subject recruitment, research coordination, clinical or academic research, or another role involving direct responsibility for human subjects research.
• The successful candidate does not need to have spent their career in regulatory compliance. However, candidates must have practical knowledge of the regulations and ethical requirements governing human subjects research, particularly the Federal Policy for the Protection of Human Subjects (Common Rule), and be able to explain how these requirements affected decisions and activities in their previous work.
• This position combines human research protections, regulatory analysis, program support, site assessment, technical writing, data analysis, and the effective use of modern artificial intelligence tools.
• We are particularly interested in candidates who have learned human research protections through practical involvement in research, even if their current job title does not include the words "regulatory" or "compliance."
• A research coordinator, IRB administrator, research recruiter, study coordinator, or other human research professional who understands why human subjects protection requirements matter-and can demonstrate how those requirements have influenced their own work-may be an excellent candidate for this position.

Responsibilities

• Review IRB minutes, research protocols, program documentation, and other materials to evaluate compliance with applicable Federal, Department of War (DoW), 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, Human Research Protection Officials (HRPOs), investigators, research personnel, 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, when appropriate, to assist with development of presentations, graphics, statistical analyses, summaries, reports, literature or regulatory research, and other activities supporting human subjects research.
• Assist in identifying new processes, methods, guidance documents, standards, and training needs for supported HRPPs.
• Maintain current knowledge of regulations, policies, and guidance applicable to human subjects research.

Requirements

• Bachelor's degree in a biomedical, socio-behavioral, scientific, health, research, or other relevant field.
• At least 2 years of professional experience working directly with human subjects research.
• Experience may include work as a regulatory compliance specialist, IRB administrator or coordinator, research coordinator, human-subject recruiter, research program administrator, clinical research professional, or another position involving substantive interaction with human subjects research.
• Demonstrated working knowledge of regulations and ethical requirements governing human subjects research, with particular emphasis on the Common Rule (45 CFR Part 46).
• Ability to describe specific situations in which human subjects protection requirements affected the candidate's work, decisions, communications, or research activities.
• Strong written and verbal communication skills and demonstrated ability to explain technical or regulatory subjects clearly.
• Experience preparing reports, presentations, data summaries, or other professional work products.
• Practical experience using generative AI or other AI-enabled tools to support professional work such as presentations, graphics, data analysis, statistical analysis, research, or written products.
• 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.
• Direct experience with an IRB or Human Research Protection Program.
• Experience in human research regulatory compliance or compliance oversight.
• Experience applying the Common Rule to actual research activities or decisions.
• Experience with Department of Defense or Department of the Navy human subjects research.
• Human research protections or regulatory compliance certification, or willingness to obtain an appropriate certification within six months of hire.
• Experience with Power BI, Tableau, statistical software, or similar analytical and visualization tools.

Skills

Required

• Objectivity
• Microsoft Excel
• Presentation software
• Generative AI tools
• Power BI (preferred)
• Tableau (preferred)
• Statistical software (preferred)