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Assistant Vice President, Research Integrity & Compliance

Employer
Saint Louis University
Location
Saint Louis County, MO
Closing date
Sep 23, 2022

View more

Sector
Pharmaceutical, Senior Management
Organization Type
Corporate
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Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nation's oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.

All About You

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:
  • 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.
  • 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.


QUALIFICATIONS

Required:
  • 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


Preferred:
  • 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.

Saint Louis University requires COVID-19 vaccinations and a booster dose for all students, staff, and faculty who are physically present on our St. Louis campuses. As a prospective and/or a new employee at Saint Louis University, you will be/are required to comply with the University's vaccination protocol. Proof of full vaccination is required before the start of employment in order to work at Saint Louis University. If you are not vaccinated, you are required to begin the vaccination process at the time of your first day of employment and submit proof of full vaccination within 30 days of your start date. Exemptions may be granted on the grounds of religious beliefs or medical circumstances. Failure to comply with the vaccine requirement within 30 days of an employee's start date will result in termination of the employment. Proof of vaccine will be submitted through an online portal made available to you during your Workday onboarding tasks.

The University will require all students, faculty and staff to obtain a booster vaccine dose prior to their start date, This applies to:
• All adults over the age of 18 years who completed their vaccine series with Pfizer or Moderna at least 6 months ago.
• Those who received the J&J vaccine at least two months ago.

Function

University Leadership

Scheduled Weekly Hours:
40

Saint Louis University is an equal opportunity/affirmative action employer. All qualified candidates will receive consideration for the position applied for without regard to race, color, religion, sex, age, national origin, disability, marital status, sexual orientation, military/veteran status, gender identity, or other non-merit factors. We welcome and encourage applications from minorities, women, protected veterans, and individuals with disabilities (including disabled veterans). If accommodations are needed for completing the application and/or with the interviewing process, please contact Human Resources at 314-977-5847.
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