Senior Regulatory Analyst – HS/IRB

🔥 16 hours ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $49 - $56 / hour

⏱ Part Time

🟠 Senior

🚔 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 the first point of contact for communications between internal and external parties • Receive and review complaints and incident reports for completeness, accuracy, participant safety concerns, and regulatory significance • Provide preliminary assessments to agency leadership • Draft correspondence, information requests, case summaries, briefing materials, and status reports • Communicate with research institutions, IRB personnel, investigators, complainants, and government officials • Request and collect information for compliance evaluations • Present analyses and recommendations to supervisors and compliance review teams • Participate in internal case review meetings and support leadership reporting • Develop reports, communication logs, trackers, briefing decks, and training materials • Track case status, milestones, correspondence, and follow-up activities • Maintain records supporting transparency, quality assurance, and audit readiness • Ensure deliverables meet quality, format, content, and accessibility standards • Monitor and communicate institutional corrective actions and compliance resolutions • Analyze research documentation, IRB records, investigator information, and institutional responses • Contribute to processes and procedures that improve team effectiveness and efficiency • Execute assignments independently under general direction and keep the supervisor updated • Perform other job-related duties as assigned

🎯 Requirements

• Master's degree in public health, clinical research, health sciences, biomedical sciences, regulatory affairs, law, public administration, or a related field • 8+ years relevant experience; additional education substitutes for experience • Experience related to human subjects research protections and regulatory compliance • Experience reviewing or supporting compliance activities related to human subjects research • Experience working with Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), research compliance offices, or regulatory oversight organizations • Knowledge of federal regulations governing human subjects research, including 45 CFR 46 (Common Rule) • Experience evaluating research protocols, incident reports, complaints, audit findings, or compliance documentation • Experience preparing written analyses, regulatory summaries, reports, or compliance correspondence • Experience managing sensitive information and maintaining detailed records accurately • Basic knowledge of project management software such as Microsoft Planner, Microsoft Project, Asana, and Smartsheet • Exceptional attention to detail, ability to execute instructions, and commitment to quality and compliance • Intermediate experience with Microsoft Office productivity software and collaboration tools such as Microsoft Teams and SharePoint • Advanced degree preferred • Certificates in project management, CIP (Certified IRB Professional), CCRP, CHRC, or related research compliance credential recommended • Foundational technical writing knowledge • Basic knowledge of AI tools, including limitations, risks, and applications to project management tasks • Experience in academic medical centers, research institutions, federal agencies, or compliance oversight organizations • Familiarity with electronic compliance or case management systems and document management tools • Public Trust clearance

🏖️ Benefits

• Competitive pay • Exceptional benefits • Flexible work options that support your lifestyle and professional growth • Meaningful opportunities to support an important public health mission