Senior Remote IRB & Compliance Analyst

Ripple Effect; Rockville (MD); On-site; USD 68,000 - 77,000; Part time

Job summary

Ripple Effect seeks a Senior Regulatory Analyst (HS/IRB) to support the Office for Human Research Protections (OHRP) within HHS. You will review complaints and submissions, evaluate compliance, and support case management with IRBs and institutions.

Strong attention to detail and written communication are essential. You will apply 45 CFR 46 and other federal rules to guide analyses, develop leadership-ready recommendations, and prepare regulatory briefs and reports.

Qualifications

• Master's degree in public health, clinical research, health sciences, or regulatory affairs.
• Demonstrated experience related to human subjects research protections and regulatory compliance.
• Basic knowledge of project management software such as Microsoft Planner, Microsoft Project, Asana and Smartsheet.
• Intermediateexperience with Microsoft Office productivity software and collaboration tools such as Microsoft Teams and SharePoint.

Responsibilities

• Be the first point of contact for communications between internal and external parties and review documents for completeness and regulatory significance.
• Provide preliminary assessment for complaints and incident reports; draft correspondence, status reports, and briefing materials.
• Engage with IRBs, HRPPs, research compliance offices, and regulatory oversight organizations as part of compliance reviews.
• Apply 45 CFR 46 (Common Rule) and other federal regulations to evaluate protocols, incidents, complaints, and audit findings.
• Prepare written analyses, regulatory summaries, reports, and compliance correspondence; maintain accurate records.

Skills

Attention to detail

Analytical thinking

Written communication

Project management familiarity

Education

Master's degree in public health or regulatory affairs

Tools

Microsoft Planner

Microsoft Project

Asana

Smartsheet

Microsoft Teams

SharePoint

Job description

Ripple Effect seeks a Senior Regulatory Analyst (HS/IRB) to support the Office for Human Research Protections (OHRP) within HHS. You will review complaints and submissions, evaluate compliance, and support case management with IRBs and institutions.

Strong attention to detail and written communication are essential. You will apply 45 CFR 46 and other federal rules to guide analyses, develop leadership-ready recommendations, and prepare regulatory briefs and reports.