Director, Research Compliance and Human Research Protection

The Director of Research Compliance and Human Research Protection provides strategic leadership and expert oversight for the institutions human research compliance and research integrity programs. This role maintains full independent accountability for the Office of Research Subject Protection (ORSP) - whose mission is to safeguard the rights and welfare of human research participants - and leads the development and implementation of research integrity frameworks policies guidelines and education.

The Director sets ORSP and research integrity strategies effective practices and identifies resolutions for highly complex organizational problems that impact the success of the organizations research portfolio. This role is a key driver in fostering a culture of research integrity establishing guidelines for human research data compliance and stewardship advancing ethical research practices and navigating the compliance implications of related and emerging regulatory landscapes.

PRINCIPAL DUTIES AND RESPONSIBILITIES

1. Strategic Leadership & Culture of Research Integrity

• Integrity Advocacy: Cultivates a proactive culture of research integrity by developing institutional standards that move beyond administrative compliance toward ethical and operational excellence.
• Strategic Alignment: Sets and directs group strategy and operations establishing priorities that ensure ORSP goals align with the mission and values of the organization.
• Organizational Impact: Acts as a nexus connecting scientists and researchers with the regulatory and compliance resources and information needed to support their research goals.

2. Research Data Stewardship & Emerging Regulatory Areas (AI PHI/PII)

• Data Integrity Guidelines: Partners with Broad Information Technology Services (BITS) other relevant Administration teams and members of the scientific community on the development of institutional policies and guidelines for research data management and integrity.
• Privacy & Protection: Collaborates with Legal Counsel the Office of Strategic Alliances and Partnerships (OSAP) and others on the implementation of policies specifically governing HIPAA-protected Protected Health Information (PHI) and Personally Identifiable Information (PII) in research contexts.
• AI Governance: Identifies and addresses the ethical and regulatory issues posed by Artificial Intelligence (AI) in human research developing policy and responsible practices for its use in data analysis protocol development and participant recruitment.
• Policy Authoring: Identifies the need for new policies in the event of shifting regulations and leads the implementation of procedures that promote compliance in emerging scientific fields.

3. IRB Compliance Monitoring & Operational Oversight

• Team Management: Directs all activities of the ORSP including supervising two staff members overseeing workload management and facilitating efficient reliable and timely operations.
• Records and Documentation: Ensure ORSP records and documentation are accurate complete and uptodate in accordance with institutional policies and applicable regulatory requirements (federal state local).
• Post-Approval Monitoring: Develops and leads a robust monitoring program to perform ongoing IRB compliance activities routine internal quality assurance reviews for active protocols and conduct for-cause and not-for-cause audits.
• Accreditation Leadership: Ensures the institutions accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and oversees all reaccreditation efforts including site visits and auditor training.
• Systems Management: Oversees the online submission and tracking systems for human research protocols ensuring data security and efficient workflows for the research community.
• Regulatory Liaison: Collaborates with federal agencies (NIH OHRP) university and hospital partners to coordinate IRB reliance activities address regulatory challenges and prevent administrative bottlenecks.

4. Community Education & Policy Outreach

• Educational Leadership: Create briefings and materials to educate the research community on ethics data stewardship and regulatory updates in appropriate scientific meetings.
• Policy Innovation: Uses innovative methods to think beyond existing organizational solutions regarding regulatory compliance and researcher engagement.
• Training Program Development: Oversees compliance with human research protection training requirements evaluating and updating instructional programs (e.g. CITI) as needed.
• Collaborative Alignment: Works in partnership with existing Broad teams on cross-cutting research ethics and compliance initiatives and institutional goals (e.g. Broad Bioethics Initiative (BBI) Broad Research Ethics Consultancy Responsible Conduct of Research (RCR) Program Broad Research Communications Lab).

5. Subject Matter Expertise & Advisory

• Institutional Advisor: Serves as the primary Subject Matter Expert for human research protection and research data stewardship defining how these areas fit within the organizational framework.
• Collaborative Alignment: Engages with research compliance offices at affiliated institutions to identify areas for alignment and share best practices.

6. Research Compliance and Bioethics Leadership

• As the Director achieves core operational milestones the scope of this role is expected to evolve offering opportunities to spearhead additional strategic initiatives and assume additional areas of responsibility across the broader research compliance bioethics and integrity portfolio

QUALIFICATIONS

• Education: Advanced degree (PhD JD or MD) strongly preferred; Masters degree in Ethics Law Science or Research Administration required.
• Experience: 10 years of progressive experience in research compliance with specific expertise in IRB operations data privacy and research integrity.
• Certification: Certified IRB Professional (CIP) or Certified in Healthcare Research Compliance (CHRC) preferred.
• Key Skills: Advanced analytical judgment and decision-making skills; ability to translate complex federal state and local regulations into actionable institutional policy; ability to assess existing operations to determine the need for new or enhanced policies and procedures; exceptional communication skills for leading community education and faculty engagement; strong organizational and project management skills; successfully collaborate with the ability to consistently exhibit diplomacy confidentiality and integrity; demonstrated experience developing and delivering training programs and educational materials on research compliance topics; commitment to upholding the highest standards of integrity ethics and professionalism in research conduct and compliance activities.

The Broad Institute will not provide sponsorship for this opportunity.