Director, Office of Regulatory Research Compliance, Howard University, Washington, DC
Howard University -
Washington, DC,
US
Director, Office of Regulatory Research Compliance
Date Posted: 2024-06-11
Job description
The Talent Acquisition department hires qualified candidates to fill positions which contribute to the overall strategic success of Howard University. Hiring staff "for fit" makes significant contributions to Howard University's overall mission.
BASIC FUNCTION:
The Director ofthe Office of Regulatory Research Compliance (ORRC) will provide day-to-day oversight of the Office of Regulatory Research Compliance in the University. The position plays a critical role in ensuring that research activities at Howard University and affiliated facilities comply with applicable Assurances, Federal, State, and the University's Policy and Procedures, and ethical standards. Thus, the Director will provide direct administrative leaders, guidance, and support to the University community on research compliance.
SUPERVISORY ACCOUNTABILITY:
The Director of the ORRC will report directly to the Associate Vice President (AVP for Regulatory Research Compliance, who is also the Institutional Official (IO). The Director will have direct day-to-day supervisory responsibility for most, if not all, the ORRC staff.
NATURE AND SCOPE:
The Director of the ORRC will ensure as the point of contact for the ORRC staff (Compliance Officers, Compliance Managers, and Administrative Staff), liaise with the ORRC AVP and Designated Institutional Official to guide the operations of the ORRC, compliance committees, external stakeholders and federal oversight agencies, students, research staff and faculty. Working with the IO, the Director will ensure that the ORRC and the IO meet regulatory reporting requirements, renewal timelines, and accreditation milestones in a timely manner.
PRINCIPAL ACCOUNTABILITIES:
Compliance Oversight:
Work with AVP/IO to provide strategic direction and leadership in the development, implementation, and maintenance of research compliance policies and procedures.
Perform day-to-day administrative management of the compliance staff and office.
Monitor and assess the university's compliance with federal, state, and local regulations related to research activities in all its facets.
Serve as the primary person for export control and research security and liaise with and report to the AVP/IO on a continuous basis.
Able to gain security clearance to allow oversight of research security and collaborative compliance oversight of the University Affiliated Research Center (UARC)
Team Leadership:
Ensures that all operational priorities are aligned with the mission and direction of a culture of compliance and the ORRC.
Manage and lead a team of compliance professionals (Compliance Manager(s), Officers, and Administrative Staff), ensuring effective collaboration, clear communication, and professional development.
Foster a culture of compliance awareness and ethical conduct within the university community.
Work with the AVP/IO to identify HU faculty members to serve on the ORRC committees
Attend the ORRC committee meetings (e.g., IRB, IACUC, IBC, COI, Research Misconduct, and others).
Work with the AVP/IO to develop an annual budget
Monitor expenditures with the Administrative Coordinator and report to the AVP/IO.
Training and Education:
Work with the AVP/IO to strengthen existing compliance programs while developing and implementing a comprehensive training program for faculty, researchers, and staff to enhance awareness of research compliance requirements.
Stay informed on the rapidly changing regulatory environment and communicate updates to the university community.
Work with the AVP and other compliance staff to ensure proper training congruent with the ORRC compliance oversight.
Audit and Monitoring:
Conduct regular audits and assessments of research activities to ensure proper quality control and identify the areas needing improvement and potential compliance risks.
Collaborate with internal and external auditors to address findings and implement corrective actions.
Develop processes and strategies to prevent future risks and re-occurrence
Provide monthly reports to the AVP/IO and work with the AVP/IO to improve quality control.
Policy Development:
Work with key stakeholders to develop, review, and update research compliance policies.
Ensure that policies align with regulatory requirements and ethical standards.
Work with the compliance manager/staff to develop standard operating procedures congruent with Federal and State regulations (including tribal laws where applicable) and HU Policies.
Regulatory Reporting:
Coordinate and oversee the preparation and submission of regulatory reports and assurance renewals related to research compliance (Office of Human Research Protection (OHRP); Office of Laboratory Animal Welfare (OLAW); Office of Research Integrity (ORI); NIH Office of Biotechnology Activities (OBA); NIH Office of Institutional Biosafety (IBC); Conflict of Interest in Research (COI); Department of Commerce - Export Control (as needed); NIH and the National Science Foundation and the Department of Defence and others as needed and relevant.
Work with the AVP/IO to prepare the University for relevant accreditations, including but not limited to AAALAC, OHRP, and FDA site visits/audits.
Work with the AVP/IO to develop a plan for the Association for the Accreditation of Human Research Protection Program (AAHRPP) accreditation
Work with the AVP/IO to serve as the primary point of contact for regulatory agencies and external auditors.
Collaboration:
Collaborate with other university departments, including the Office of General Counsel (OGC), the Sponsored Programs, the Chief Compliance Office, Environmental Health and Safety, Radiation Safety, and the UARC, to address interdisciplinary compliance concerns.
Provide guidance to researchers, especially students, during the development and submission of research proposals.
Collaborate with the Graduate School on the Responsible Conduct of Research (RCR) Training to ensure students graduate in a timely manner.
Risk Management and Quality Control
Identify, assess, and mitigate risks associated with research compliance issues.
Develop and implement strategies to enhance the university's overall risk management framework.
Liaise with the ORRC committee leadership (IRB, IBC, IACUC, COI, Export Control, Research Misconduct, MTA) to manage reported non-compliance and mitigate risk.
Ensure the Compliance Manager(s)/Staff to track and analyze turnaround times and backlogs for quality control.
Provides advice and assistance to investigators regarding the procedural requirements of complex compliance issues.
Prepares routine technical documents regarding institutional compliance with federal requirements that are routinely audited and provides a periodic report to the AVP/IO.
Work with the AVP/IO and the Compliance Manager to plan and complete the HU annual Institutional Assessment.
Ensure the Compliance Manager(s) to ensure that compliance staff complete meeting minutes in a timely and accurate manner.
Ensure that the Compliance Manager(s)/Staff perform periodic audits of the meeting minutes, committee meeting attendance, and quorum.
Ensure that the Compliance Manager(s) Other related duties as assigned.
CORE COMPETENCIES:
Be present during difficult periods to lead and address challenges.
Excellent people skills to manage staff of various expertise.
Ability to exercise sound judgment and facilitate good and timely decisions that comport with the university objectives and federal regulations.
Ability to maintain confidentiality.
Skill in planning, analyzing, and coordinating activities and establishing priorities.
Skill in planning, analyzing, and coordinating activities and establishing priorities; strong writing, note-taking, and transcription skills.
Strong knowledge of compliance and business processes skills.
Excellent verbal and written communication skills.
MINIMUM REQUIREMENTS:
Doctoral or advanced degree in a relevant field (e.g., law, compliance with an MBA) with ~10 years research compliance experience preferably at an academic setting. A master's degree with ~ 15 years of research compliance experience in an academic setting would be considered.
Extensive experience in research compliance within a university or similar research environment.
In-depth knowledge of federal regulations governing research (e.g., OHRP, FDA, NIH, Department of Defense (DoD), Department of Commerce, OLAW, USDA).
Strong leadership and managerial skills with the ability to foster a culture of compliance and ethical conduct.
Excellent communication and interpersonal skills.
Experience in developing and delivering compliance training programs.
Familiarity with auditing processes and corrective action plans.
Ability to collaborate effectively with diverse stakeholders.
BASIC FUNCTION:
The Director ofthe Office of Regulatory Research Compliance (ORRC) will provide day-to-day oversight of the Office of Regulatory Research Compliance in the University. The position plays a critical role in ensuring that research activities at Howard University and affiliated facilities comply with applicable Assurances, Federal, State, and the University's Policy and Procedures, and ethical standards. Thus, the Director will provide direct administrative leaders, guidance, and support to the University community on research compliance.
SUPERVISORY ACCOUNTABILITY:
The Director of the ORRC will report directly to the Associate Vice President (AVP for Regulatory Research Compliance, who is also the Institutional Official (IO). The Director will have direct day-to-day supervisory responsibility for most, if not all, the ORRC staff.
NATURE AND SCOPE:
The Director of the ORRC will ensure as the point of contact for the ORRC staff (Compliance Officers, Compliance Managers, and Administrative Staff), liaise with the ORRC AVP and Designated Institutional Official to guide the operations of the ORRC, compliance committees, external stakeholders and federal oversight agencies, students, research staff and faculty. Working with the IO, the Director will ensure that the ORRC and the IO meet regulatory reporting requirements, renewal timelines, and accreditation milestones in a timely manner.
PRINCIPAL ACCOUNTABILITIES:
Compliance Oversight:
Work with AVP/IO to provide strategic direction and leadership in the development, implementation, and maintenance of research compliance policies and procedures.
Perform day-to-day administrative management of the compliance staff and office.
Monitor and assess the university's compliance with federal, state, and local regulations related to research activities in all its facets.
Serve as the primary person for export control and research security and liaise with and report to the AVP/IO on a continuous basis.
Able to gain security clearance to allow oversight of research security and collaborative compliance oversight of the University Affiliated Research Center (UARC)
Team Leadership:
Ensures that all operational priorities are aligned with the mission and direction of a culture of compliance and the ORRC.
Manage and lead a team of compliance professionals (Compliance Manager(s), Officers, and Administrative Staff), ensuring effective collaboration, clear communication, and professional development.
Foster a culture of compliance awareness and ethical conduct within the university community.
Work with the AVP/IO to identify HU faculty members to serve on the ORRC committees
Attend the ORRC committee meetings (e.g., IRB, IACUC, IBC, COI, Research Misconduct, and others).
Work with the AVP/IO to develop an annual budget
Monitor expenditures with the Administrative Coordinator and report to the AVP/IO.
Training and Education:
Work with the AVP/IO to strengthen existing compliance programs while developing and implementing a comprehensive training program for faculty, researchers, and staff to enhance awareness of research compliance requirements.
Stay informed on the rapidly changing regulatory environment and communicate updates to the university community.
Work with the AVP and other compliance staff to ensure proper training congruent with the ORRC compliance oversight.
Audit and Monitoring:
Conduct regular audits and assessments of research activities to ensure proper quality control and identify the areas needing improvement and potential compliance risks.
Collaborate with internal and external auditors to address findings and implement corrective actions.
Develop processes and strategies to prevent future risks and re-occurrence
Provide monthly reports to the AVP/IO and work with the AVP/IO to improve quality control.
Policy Development:
Work with key stakeholders to develop, review, and update research compliance policies.
Ensure that policies align with regulatory requirements and ethical standards.
Work with the compliance manager/staff to develop standard operating procedures congruent with Federal and State regulations (including tribal laws where applicable) and HU Policies.
Regulatory Reporting:
Coordinate and oversee the preparation and submission of regulatory reports and assurance renewals related to research compliance (Office of Human Research Protection (OHRP); Office of Laboratory Animal Welfare (OLAW); Office of Research Integrity (ORI); NIH Office of Biotechnology Activities (OBA); NIH Office of Institutional Biosafety (IBC); Conflict of Interest in Research (COI); Department of Commerce - Export Control (as needed); NIH and the National Science Foundation and the Department of Defence and others as needed and relevant.
Work with the AVP/IO to prepare the University for relevant accreditations, including but not limited to AAALAC, OHRP, and FDA site visits/audits.
Work with the AVP/IO to develop a plan for the Association for the Accreditation of Human Research Protection Program (AAHRPP) accreditation
Work with the AVP/IO to serve as the primary point of contact for regulatory agencies and external auditors.
Collaboration:
Collaborate with other university departments, including the Office of General Counsel (OGC), the Sponsored Programs, the Chief Compliance Office, Environmental Health and Safety, Radiation Safety, and the UARC, to address interdisciplinary compliance concerns.
Provide guidance to researchers, especially students, during the development and submission of research proposals.
Collaborate with the Graduate School on the Responsible Conduct of Research (RCR) Training to ensure students graduate in a timely manner.
Risk Management and Quality Control
Identify, assess, and mitigate risks associated with research compliance issues.
Develop and implement strategies to enhance the university's overall risk management framework.
Liaise with the ORRC committee leadership (IRB, IBC, IACUC, COI, Export Control, Research Misconduct, MTA) to manage reported non-compliance and mitigate risk.
Ensure the Compliance Manager(s)/Staff to track and analyze turnaround times and backlogs for quality control.
Provides advice and assistance to investigators regarding the procedural requirements of complex compliance issues.
Prepares routine technical documents regarding institutional compliance with federal requirements that are routinely audited and provides a periodic report to the AVP/IO.
Work with the AVP/IO and the Compliance Manager to plan and complete the HU annual Institutional Assessment.
Ensure the Compliance Manager(s) to ensure that compliance staff complete meeting minutes in a timely and accurate manner.
Ensure that the Compliance Manager(s)/Staff perform periodic audits of the meeting minutes, committee meeting attendance, and quorum.
Ensure that the Compliance Manager(s) Other related duties as assigned.
CORE COMPETENCIES:
Be present during difficult periods to lead and address challenges.
Excellent people skills to manage staff of various expertise.
Ability to exercise sound judgment and facilitate good and timely decisions that comport with the university objectives and federal regulations.
Ability to maintain confidentiality.
Skill in planning, analyzing, and coordinating activities and establishing priorities.
Skill in planning, analyzing, and coordinating activities and establishing priorities; strong writing, note-taking, and transcription skills.
Strong knowledge of compliance and business processes skills.
Excellent verbal and written communication skills.
MINIMUM REQUIREMENTS:
Doctoral or advanced degree in a relevant field (e.g., law, compliance with an MBA) with ~10 years research compliance experience preferably at an academic setting. A master's degree with ~ 15 years of research compliance experience in an academic setting would be considered.
Extensive experience in research compliance within a university or similar research environment.
In-depth knowledge of federal regulations governing research (e.g., OHRP, FDA, NIH, Department of Defense (DoD), Department of Commerce, OLAW, USDA).
Strong leadership and managerial skills with the ability to foster a culture of compliance and ethical conduct.
Excellent communication and interpersonal skills.
Experience in developing and delivering compliance training programs.
Familiarity with auditing processes and corrective action plans.
Ability to collaborate effectively with diverse stakeholders.