Principal Regulatory Compliance Professional – HS/IRB

🔥 16 hours ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $59 - $67 / hour

⏱ Part Time

🔴 Lead

🚔 Compliance

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Ripple Effect

WebsiteLinkedInAll Job Openings

51 - 200 employees

📣 Marketing

🏥 Healthcare

📦 Logistics

Marketing • Healthcare • Logistics

Ripple Effect is a consulting company that specializes in delivering top-tier consulting services and talent across federal, private, and non-profit sectors. Established in 2003, Ripple Effect has earned recognition for its role in shaping policies and programs that define the nation. The company provides a wide range of services including program management, technical and scientific support, communications and outreach, research and evaluation, and digital transformation. With a focus on delivering impactful outcomes, Ripple Effect boasts a multidisciplinary team of experts ready to enhance business operations and drive success for their clients. Furthermore, the company emphasizes diversity and inclusion and has been recognized as one of the nation's best and brightest companies to work for. Their work spans various sectors, showcasing their commitment to excellence and flexibility in meeting client needs.

📋 Description

• Serve as a senior subject matter expert supporting OHRP's compliance oversight mission and protection of human subjects in HHS-conducted or supported research • Analyze and provide recommendations concerning compliance with 45 CFR 46 (the Common Rule) • Evaluate allegations of noncompliance • Review institutional submissions, corrective action plans, complaints, incident reports, unanticipated problems, and IRB regulatory determinations • Advise OHRP leadership on regulatory, ethical, and operational human-subjects-protection issues • Lead cross-functional compliance discussions • Prepare analyses, case summaries, and briefing materials for leadership decision-making • Develop and maintain compliance review schedules and pre- and post-review documentation • Ensure deliverables meet internal and external quality standards through QMS and corrective action plans • Evaluate institutional responses and supporting documentation for adequacy and regulatory compliance • Identify deficiencies, inconsistencies, regulatory gaps, and remediation needs • Support policies and procedures for evolving laws and regulations and liaise with regulatory agencies • Oversee compliance documentation for clarity and accuracy • Resolve compliance issues and recommend process improvements • Participate in policy discussions, working groups, cross-functional reviews, special projects, guidance development, and organizational improvement initiatives • Operate independently under senior leadership direction, managing performance, training, and resources to ensure audit-ready compliance outcomes • Perform other job-related duties as assigned

🎯 Requirements

• Master's degree in science or relevant fields • 8+ years' relevant experience; additional education substitutes for experience • 2+ years of project management experience • Education or experience in science, public health, or research • Substantial experience with Institutional Review Boards (IRBs), human subjects research programs, policy interpretation, policy implementation and monitoring, and compliance reviews, investigations, audits, evaluations, or regulatory assessments • Experience reviewing complaints, allegations, incident reports, corrective action plans, and institutional compliance documentation • Knowledge of human research protection programs in academic, healthcare, federal, or research environments • Intermediate experience with Microsoft Office, Microsoft Teams, and SharePoint • Exceptional attention to detail and demonstrated ability to execute instructions • Familiarity with electronic IRB management systems and compliance tracking systems • Certification in relevant regulatory areas, including CIP, recommended • Intermediate experience with AI tools, including their limitations and risks, and applying them to regulatory and compliance activities • Experience with federal agencies, academic medical centers, research institutions, or healthcare systems involving human subjects research • Experience with government contracting • Specific content-area experience aligned to project work may be required • Public Trust clearance

🏖️ Benefits

• Competitive pay • Exceptional benefits • Flexible work options • Meaningful opportunities to support important public health missions • Professional growth opportunities • Work/life balance support • Personalized benefits and culture programs