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Senior Regulatory Analyst (HS/IRB) (Part-Time)

2 hours, 36 minutes ago
United States
Part-time
Lead
Compliance Manager
Operations
Asana
Apply Now
Ripple Effect

Ripple Effect

Ripple Effect is an award-winning innovator in strategy and public policy consulting, providing a wide range of services to federal government and nonprofit clients, with a multidisciplinary team dedicated to improving performance and creating lasting ...

Professional Services
51-250
Founded 2004
View All Jobs 3

Description

  • Serve as a primary contact for internal and external communications regarding complaints and incident reports.
  • Review complaints and incident documentation for completeness, accuracy, participant safety concerns, and regulatory significance.
  • Conduct preliminary assessments and support compliance evaluations involving IRBs, research institutions, and investigators.
  • Draft correspondence, information requests, case summaries, briefing materials, reports, trackers, and training content.
  • Request and analyze research documentation, IRB records, investigator information, and institutional responses.
  • Track case statuses, milestones, correspondence, corrective actions, and follow-up activities.
  • Present analyses and recommendations to supervisors, leadership, and compliance review teams.
  • Maintain accurate, transparent, audit-ready records and ensure deliverables meet quality, accessibility, and formatting standards.
  • Contribute to improved processes, procedures, and solutions for complex compliance issues.

Requirements

  • Master’s degree in public health, clinical research, health sciences, biomedical sciences, regulatory affairs, law, public administration, or a related field.
  • 8+ years of relevant experience; additional education may substitute for experience.
  • Experience supporting human-subjects research protections and regulatory compliance activities.
  • Experience working with IRBs, HRPPs, research compliance offices, or regulatory oversight organizations.
  • Working knowledge of federal human-subjects research regulations, including 45 CFR 46 (Common Rule).
  • Experience evaluating research protocols, incident reports, complaints, audit findings, or compliance documentation.
  • Strong written communication, analytical ability, attention to detail, and recordkeeping skills.
  • Basic knowledge of Microsoft Planner, Microsoft Project, Asana, or Smartsheet, plus intermediate Microsoft Office, Teams, and SharePoint experience.
  • Preferred: advanced degree, project management or research compliance credentials such as CIP, CCRP, or CHRC.
  • Preferred: experience with research institutions or federal agencies and electronic compliance or case management systems.

Benefits

  • $49.23–$56.62 per hour.
  • Fully remote work arrangement, with preference for candidates local to or within driving distance of an HHS badging location.
  • Competitive pay and comprehensive benefits package.
  • Programs supporting work-life balance and personalized employee preferences.
  • Flexible work options supporting professional growth.

Interested in this position?

Apply directly on the company website

Apply Now

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