Director, Human Research Protections Program

Virginia Commonwealth University seeks a dynamic and experienced leader to join our team as the Director of the Human Research Protections Program Office. This pivotal role will oversee and enhance our commitment to safeguarding the rights and welfare of research participants, ensuring compliance with ethical standards and regulatory requirements. As the Director, you will lead a dedicated team in fostering a culture of integrity and accountability in research practices, while collaborating with researchers, institutional leadership, and external stakeholders. If you are passionate about advancing ethical research and possess a strong background in human subjects protection, we invite you to help shape the future of our research environment.

Since its inception, as the Commonwealth of Virginia’s namesake institution, VCU has promoted public impact research.  We distinguish VCU as a vibrant public research university where researchers, educators, practitioners and entrepreneurs innovate together to improve lives and address societal challenges.  Our research goals include:

• Amplifying VCU’s impact on society through excellence across all disciplines, knowledge creation and transdisciplinary research. Building a collaborative research culture that powers meaningful change and impact and is based on ethics, integrity, inclusive practices and critical and analytical thinking. Implementing a research infrastructure model that is scalable, nimble and ready for growth.

Human research is a significant part of how VCU research is shaping the future.  At VCU, our human research includes a robust portfolio including social-behavioral and educational research, biomedical/clinical research and clinical trials including investigational drugs, devices, biologics and dietary supplements. 

The Director of a human research protections program office is expected to be an engaged and well-respected leader, strategic thinker, and able to influence and serve as a champion for the training and teamwork necessary to ensure the ethical foundation, responsibility, and integrity of the program. The Director will report to the Associate Vice President for Strategy and Regulatory Affairs, a former HRPP professional who also oversees key strategic priorities that preserve the integrity of the University’s growing research ecosystem. 

Duties and Responsibilities of the HRPP Director:

Federal responsibilities typically carried out by the Human Research Administrator identified on the institutional Federal wide Assurance (FWA), including:

• Advising on institutional compliance with the terms of the OHRP Federal Wide Assurance (FWA) Management of the IRB Membership, including working collaboratively with the Chairperson and others for ensure appropriate membership, participation, and engagement Oversight of all federal reporting requirements to ensure clear and prompt self-governance, including ensuring that other cognizant federal agencies or sponsors are informed as appropriate.

Leadership and mentorship in human research protections:

• Leadership of human research protections professionals both within the VCU HRPP Office as well as across the enterprise. Establish a community of practice for those who work to support human research protections, HRPP and IRB professionals and members, as well as those who prepare submissions, review routing through schools and departments, and conduct training and outreach programs, including those in the VCU Clinical and Translational Science Center. Guide the development of future human research protections professionals by modeling and emphasizing effective communication skills, strong ethics, empathy, technical expertise, and the ability to inspire employees. Cultivate a positive work environment that is essential to continuous quality improvement. Provide guidance to IRB, researchers, research staff, and administrators regarding the interpretation and application of regulations, laws, and policies Demonstrate curiosity in new technologies that will shape the future of human research protections as well as change what is understood as ‘identifiable’.

Serve as the subject matter expert for the ongoing program development:

• Collaborate with partners across the enterprise to reduce administrative burden while ensuring the ethical and responsible conduct of human research. Advocate for quality and compliance processes that are transparent and clear to the research community, leveraging new software implemented to streamline operations.

• Ensure that the eight elements of an effective compliance program are reflected in practice:

• Define annual program goals that align the HRPP Office with a common strategy.  Ensure a deep appreciation of and respect for academic values and culture and an understanding of the critical role that the position serves in sustaining and broadening a research university's intellectual rigor.
• Monitor the human research regulatory environment and changes to laws and regulations that impact human research protections.
• Ensure that policies, procedures, and standards for practice are clear, concise, and updated.
• Provide training and education responsive to unanticipated problems involving risk to participants or others, serious or continuing non-compliance, and compliance case discussions to support improved understanding of why policies and procedures are in place. Present seminars and workshops on the protection of human participants in research to faculty, staff, students, and the community.
• Serve as the IRB compliance officer with oversight over the process and documentation necessary to respond to questions, concerns, audits, or inspections. Collaborate with partners who serve in adjacent compliance roles that contribute to the VCU HRPP.  Appointed by the Associate Vice President for Strategy and Regulatory Affairs, serve as a member of the Research Compliance Advisory Council. 
• Ensure that an adequate monitoring approach is deployed to evaluate the effectiveness of the human research protection program.
• Communicate effectively, ensuring that everyone in the organization understands human research protections.
• Ensure that non-compliance is addressed, when determined by the IRB or identified within the program, and results in the responsible party proposing corrective and preventive actions and that these actions are defined in alignment with SMART goals.
• Cultivate a culture absent of retaliation, where those who express concerns, in good faith, (including self-reporting) are not retaliated against and do not experience harassment.  This includes ensuring the integrity of the deliberations and decisions of the IRB/ethics board are not unduly influenced.

Minimum Qualifications:

M.A./M.S. degree or equivalent related experience. A minimum of seven years of experience, with supervisory or management experience, in a Human Research Protections Program setting at an academic medical center Demonstrated understanding of federal regulations and agency guidelines for human subjects, including HHS, FDA, HIPAA, FERPA, and other agency specific regulations (such as DOD, DoED, NIH, etc.) Managerial experience and proven success in managing an Institutional Review Board Proven leadership and management skills, including the creation of a HRPP strategy to grow and adjust to research needs, establishing and measuring goals and objectives, optimizing and monitoring work assignments, facilitating career development and staff retention Ability to formulate broad policy recommendations for VCU regarding human research protection issues, including educational and training requirements for IRB members, staff, and investigators Ability to apply flexibility and creativity to a complex array of compliance issues Ability to work with peers and other units at VCU to create a cohesive human subjects protection plan Skilled communication abilities with all levels of stakeholders Skill in establishing relationships with human subjects' regulatory agencies on state and federal level Excellent analytical and independent problem-solving skills, organizational, coordination and prioritization skills Ability to synthesize information from multiple sources to produce succinct, detail-oriented, and accurate documents, policies, reports, and announcements Certified IRB Professional (CIP) or Certified IRB Manager (CIM).

Preferred Qualifications:

Certified IRB Professional (CIP) certification preferred. 10 years in progressive management and leadership positions in academic setting. Experience in public academic institution Advanced degree (Ph.D, JD) Job Requirements

Shift - Monday - Friday (Work outside of normal business hours may be required) Position requires 60% or more onsite. Salary to be commensurate with qualifications of the selected candidate within the established range (generally minimum-midpoint) of the position Work Location: Richmond, VA