Reporting to the Associate Vice President for Research, the Assistant Vice President (AVP), Research Integrity & Compliance coordinates, oversees, and evaluates programs to ensure compliance with federal, state, and local regulations and internal policies relating to research activities. The Assistant Vice President is also responsible for monitoring federal and state regulatory developments and changes to university policies to ensure continued compliance with applicable research regulations. The position participates in developing and implementing University research and development policies, objectives, and collaborative initiatives.
The AVP provides leadership and oversight in maintaining a compliance infrastructure for research integrity and develops and implements effective educational programs that enhance the responsible conduct of research and will additionally help facilitate research and development activities to maintain the University’s aggressive competitive position in research areas through expansion of SLU’s research initiatives. The position is committed to collaboration across the University with key partners in the School of Medicine, the Office for University Compliance and Ethics, and the Office of University Counsel, as well as federal sponsors, accrediting agencies, and regulatory entities. The AVP will have a dotted line to the Vice President for University Compliance and Ethics.
Duties and Responsibilities:
<ul>Leads, directs, and manages research and compliance operations and budget for the University's research compliance programs, including critical areas of animal care and use, biosafety/biosecurity, conflict of interest, controlled substances, environmental health safety, foreign influence in research, human subjects research, radiation safety, research misconduct, and responsible conduct of research. This responsibility includes the overall operation, effectiveness, and perception of the Institutional Animal Care and Use Committee (IACUC), the Financial Conflict of Interest Committee (COIRC), the Institutional Biosafety Committee (IBC), the Institutional Review Board (IRB), the Radiation Safety Committee (RSC), in addition to their individual research compliance programs.</ul>
Serve as the Federal and State Regulatory Liaison, the point person for the University with the NIH Office of Laboratory Animal Welfare (OLAW), the USDA Animal Plant and Health Protection Services (APHIS); the Association for the Assessment and Accreditation of Animal Care (AAALAC), the Office of Biotechnology Activities (OBA), and serves as the Institutional Contact for Dual Use Research of Concern (ICDURC) and Institutional Official (IO) for the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA); coordinates correspondence and responses for communications to external regulatory agencies.
Coordinates, oversees, and evaluates research compliance programs to ensure faculty, staff, and student compliance with federal, state, and local regulations and internal policies relating to research activities; monitors federal and state regulatory developments and changes to university policies to ensure continued compliance with applicable research regulations.
In partnership with the Director of the Human Research Protection Program (HRPP), directs and oversees institutional quality assurance efforts, including PI quality assurance reviews (QAR), internal quality assurance reviews (IQAR) assessing effectiveness of the HRPP, policies, and procedures; monitoring of human subject research protocols for measures of overall compliance; for-cause and noncompliance audits; preparation of the analysis/summary of results, identification of alternatives for resolution of issues, and development and monitoring of corrective and preventative action plans (CAPA).
Under the direction of the Associate Vice President for Research acts as the designated Research Integrity Officer (RIO), oversees and manages human subject and research misconduct inquiries and investigations regarding investigator non-compliance as made by federal oversight agencies, individual subject complaints, serious adverse events, unanticipated problems involving risks to subjects, and allegations of investigator noncompliance with IRB approvals; manages and conducts highly confidential and sensitive research misconduct reports with recommendations for remediation, if applicable.
Directs and supervises the managers and directors of relevant programs and their operations; develops performance standards and conducts performance evaluations; reviews and approves personnel actions in accordance with University policies and state regulations.
Develops, assesses, and oversees the administration of adequate institutional training and education for numerous compliance-related subjects, including animal care and use, biosafety/biosecurity, conflict of interest, controlled substances, environmental health safety, export controls, foreign influence in research, human subjects research, radiation safety, research misconduct, and responsible conduct of research.
Participates with other senior leaders to establish strategic plans and objectives of the institution in expanding the University’s research enterprise; supports the development and implementation of University research policies, objectives, and collaborative initiatives to improve research compliance; leads staff in identifying areas in need of policy development or investigator guidance, researching, and drafting such documents for review and approval by the appropriate committee(s).
Performs other duties as assigned.
Advanced degree in a relevant field from an accredited college or university. Minimum of ten (10) years of experience working in a research regulatory management and compliance. An equivalent combination of education and experience may be considered.
Extensive knowledge of regulations and laws relating to research involving animal care and use, biosafety/biosecurity, conflict of interest, controlled substances, environmental health safety, export controls, foreign influence in research, human subjects research, radiation safety, research misconduct, and responsible conduct of research, with experience maintaining institutional accreditation.
Knowledge of research methodology and design with relevant experience conducting, reviewing, and/or monitoring research program coordination/administration and research misconduct and non-compliance investigations.
Ability to evaluate program or unit performance and collaboratively develop alternative methods to improve performance and meet established objectives and implement training and educational workshops in an academic setting.
Experience strategically planning and serving as a catalyst for organizational change, cultivating a shared vision with others, and motivating others to transfer vision into action.
Strong analytical skills with the ability to identify issues and solve problems within the framework of federal and state regulations, accreditation standards and institutional requirements
Managerial and supervisory skills
Excellent written and oral communication and presentation skills and ability to interact effectively with diverse research audiences
Good organizational skills with the ability to work on multiple projects simultaneously
Professional demeanor with the ability to work both collaboratively and independently, to maintain confidentiality, and to provide excellent customer service
Computing proficiency, with the ability to create and manage databases.
Flexibility and ability to adapt to a changing environment
Readiness to learn new techniques and operating procedures.
Membership in professional organizations.
This position may be eligible for a flexible work arrangement, to include a possible non-standard schedule, and/or the ability to work off-site part of the time.