JOB SUMMARY

The Associate Vice Provost for Research Compliance integrates research compliance activities as part of a comprehensive overarching research compliance program institution wide that will help expand the impact of Drexel’s research activities. The position leads the institutional research compliance program to strategically align the University compliance area services, develop infrastructure, and provide oversight in the implementation of research compliance-related policies and procedures. The position must be able to influence compliance initiatives, priorities, and risk tolerance at an institutional level; and provide for an enterprise-wide level of research oversight to prevent identify, respond to, mitigate, and monitor research compliance.
Our goal is to maintain and expand a culture of effective research compliance across the research enterprise. This leader works closely with fellow leaders in the Office of Research & Innovation, Office of General Counsel, Office of Compliance, Privacy and Internal Audit, Office of Global Engagement, federal sponsors, accrediting agencies, and regulatory entities. As a member of the Office of Research & Innovation leadership team, you will participate in the regular meetings of the ORI Leadership Council, Research Council, Research Administration Advisory Committee, and International Research Risk Working Group. When necessary, you will also attend the Enterprise Risk Management Committee, the Audit Committee of the Board of Trustees, and the University Executive Council. In these forums, you will provide insight and perspective on University Research Compliance operations and strategic initiatives.
You would act as a liaison between the Office of the EVP for Research & Innovation, Office of Research & Innovation, and the faculty and staff of Drexel University on matters related to research compliance, including human research protections, animal use and care programs, export control, research security, research integrity, responsible conduct of research, research conflicts of interest, Institutional Review Boards (IRB), Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC) as well as regulations related to these areas. Develop, review, and maintain contemporary research compliance policies and procedures, and performs other tasks as assigned by the EVPRI. Develop, review, and maintain contemporary research compliance policies and procedures, and performs other tasks as assigned by the EVPRI.

REQUIRED QUALIFICATION

• Minimum of a Master’s Degree or the equivalent combination of education and work experience. (Please review the Equivalency Chart for additional information.)
• Minimum of 10 years of experience in research administration and at least 7 years of leadership experience
• At least 7-10 years of experience in progressively responsible supervisory and administrative experience in an organization(s) with complex and diverse research administration operations.
• Extensive knowledge of compliance principles, terminology, and regulatory requirements that impact the research endeavors of academic research institutions required.
• Ability to work effectively in a team environment with a focus on solutions and problem solving.
• Ability to lead the development, deployment, and management of university wide research compliance trainings.
• Ability to effectively collaborate with faculty and staff in units that vary greatly in size and organizational structure.

PREFERRED QUALIFICATIONS

• Master’s degree in an appropriate area and 10 years of relevant experience or
• Bachelor’s Degree in an appropriate area and 15 years of relevant experience.

• Lead and manage all Research Compliance aspects of the Office of Research & Innovation which includes:
• Human Research Protections (HRP)
• Supervise and manage the HRP program ensuring that research involving human subjects is consistent with the standards of care and regulatory requirements.
• Quality Assurance/Quality Improvement (QA/QI)
• Supervise and manage the QA/QI program ensuring that patient and animal care is consistent with standards of care and regulatory requirements by designing and implementing assessments that measure and evaluate human and animal research.
• Performance management to ensure quality measurement, performance improvement, and regulatory compliance for animal and human research.
• Review, approve, and escalate as necessary quality and compliance data findings and trends.
• Institutional Animal Care and Use Committee (IACUC)
• Supervise and manage the Office of IACUC Administration (OIA) in providing quality and service-oriented support to Drexel University’s Institutional Animal Care and Use Committee (IACUC), which has oversight of Drexel’s animal care and use program.
• Performance management to ensure timely review and approval of proposed animal use; regular inspection of facilities and animal use areas; and ongoing assessment of animal care and use.
• Biosafety
• Manages and supervises the administrative office of the University Bio-Safety Committee (UBSC) responsible for reviewing all proposed projects involving biohazardous materials in order to protect the health and safety of University students, visitors, faculty, and professional staff in observing safe laboratory practices for biological materials as prescribed by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), and endeavors to assure that research is done in secure facilities in compliance with all local, state, and federal regulations.
• Research Integrity
• Oversees the University’s Research Integrity Officer and activities related to investigations.
• Partners with University stakeholders to review and update responsible conduct of research training.
• Research Conflicts of Interest
• While extramural activities benefit the university, and are encouraged, in some circumstances such activities give rise to conflicts of interest. This role has responsibility for oversight of the Research COI (Conflict of Interest) program to ensure compliance with federal regulations and institutional policies.
• Responsibilities include supervision of COI staff; coordination with administrative leadership; maintenance of records documenting COI activity; and tracking compliance with management plans.
• Export Controls
• Oversees the management and continued implementation of effective export compliance programs under the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations (EAR).
• The ED for Research Compliance has responsibility for oversight of the export control program to ensure compliance with federal regulations and institutional policies.
• Responsibilities include supervision of export control staff; coordination with faculty and leadership; maintenance of records documenting export activity; and tracking compliance with technology control plans and risk assessments.
• Research Security & Foreign Influence
• Works with University stakeholders to coordinate the University’s efforts to promote international research collaborations in a manner that is consistent with applicable laws and regulations.
• Stays abreast of the changing regulations related to these topics and communicates this to the research community.
• Administrative responsibilities include but are not limited to:
• Reviewing federal and state statutory and regulatory updates and other resource materials in order to remain abreast of national and state trends in research compliance, actively participate in national organizations (such as the Council on Governmental Relations), and attend national conferences and educational seminars.
• Serve as point of contact with external regulators within the scope of activities designated here.
• Advise the EVPRI, and compliance administrators, on national trends and enforcement activities affecting the research enterprise, including those involving foreign activities.
• Prepare appropriate communications for affected faculty and staff, in consultation with the Office of the General Counsel.
• Work with direct reports to develop and implement policies and procedures
• Work with direct reports to develop and provide education and outreach, including utilizing innovative efforts to communicate compliance initiatives and provide compliance resources that are part of this portfolio in partnership with the ORI communications efforts (i.e. websites, newsletters, etc.).
• Work with direct reports to conduct risk assessments and continuous monitoring processes with implementation of corrective actions/improvement plans for these areas, as needed.
• Prepare reports as necessary for the Executive Vice Provost for Research & Innovation (EVPRI) including outcomes of annual assessments.
• Immediately report any material compliance issues to the EVPRI and other applicable compliance staff and leadership.
• Review federal and state statutory and regulatory updates and other resource materials in order to remain abreast of national and state trends in research compliance, actively participate in national organizations (such as the Council on Governmental Relations), and attend national conferences and educational seminars.
• Leadership and team building to achieve KPI targets in all research compliance.
• Relationship building and customer service.
• Have a particular emphasis on customer service, technology and data-collection improvements to support better service, implementation, management, performance of programs, and monitoring and self-correction
• Verifiable record of successfully managing large, diverse set of tasks and projects.
• Demonstrated interpersonal and leadership skills including expertise in building and managing complex relationships across organizational boundaries.
• Strong organizational skills, attention to detail and dependability are essential .
• Excellent verbal and written communication skills.
• High level of integrity and work ethic.