The Pennsylvania State University seeks a highly motivated and experienced professional to serve as the Assistant Director of Research Quality and Integrity in the Office for Research Protections (ORP). Reporting to the Education, Quality, and Integrity Program (EQUIP) Director, the Assistant Director will assist the Director in providing leadership and oversight of the Quality Assurance/Quality Improvement (QA/QI), and the Research Integrity programs. As part of the Office of the Senior Vice President for Research, the ORP supports Penn State’s active research enterprise. With $968 million in annual research expenditures, Penn State ranks in the top 25 of the nation’s public research universities.
The Assistant Director will provide oversight and lead activities for the Quality Assurance/Quality Improvement program for the Office for Research Protections. The QA/QI program includes post-IRB approval monitoring, FDA IND/IDE support, management of the University Park clinicaltrials.gov institutional account, and internal quality assurance and improvement activities. In collaboration with the QA/QI team, the Assistant Director will prepare for and conduct FDA, and non-FDA, on-site reviews of selected human subject research projects to assess compliance with federal regulations, IRB requirements, and other relevant policies; and to educate and assist researchers with maintaining compliance. This includes preparing related reports and making recommendations regarding observations and suggested actions. The Assistant Director will oversee both IND/IDE (FDA) QM support, and clinical trials support programs, for investigators at University Park and all commonwealth campuses, with the exception of the College of Medicine and Penn State Health.
The Assistant Director will manage and oversee the research integrity process for addressing allegations of research misconduct. As outlined in University policy RP02, this includes the assessment, inquiry, and investigation of all allegations of research misconduct alleged to have been committed by University faculty, staff, or students. Along with the Research Integrity Officer (RIO) and Research Integrity team, the Assistant Director will coordinate the management of cases arising under RP02. This includes responsibility for coordinating and providing on-going support to all research misconduct inquiry and investigation committees. The Assistant Director will serve as an expert and resource to the University community on federal and University policies related to research misconduct, professional misconduct, and research integrity. The Assistant Director is responsible for oversight and supervision of three program staff and serves as a liaison between the Director, program staff, the Research Integrity Officer, and the Deputy Research Integrity Officer. This individual also serves as the Director's delegate in his/her absence.
Typically requires a Bachelor's degree or higher plus seven years of related experience, or an equivalent combination of education and experience. Demonstrated experience with supervision and management, relevant research or professional experience ideal. This position requires exceptional professionalism and proven effectiveness as a project manager, communicator, problem-solver, and negotiator, with a strong customer-service orientation. Must be able to exercise sound, independent judgment and discretion; must maintain confidentiality. The ideal candidate will have knowledge of and experience with quality management, regulatory compliance policies/processes, and/or internal investigations, understanding of regulations governing human subject research desired. It is critical that the candidate demonstrate excellent verbal and written communication skills. Proficiency with Microsoft Office expected. This position is located at University Park in State College, PA. Occasional travel to other campuses will be expected. Apply online at https://psu.jobs/job/93383
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Penn State is an equal opportunity, affirmative action employer, and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Internal Number: 93383
About Penn State University
As part of the Office of the Senior Vice President for Research, the Office for Research Protections supports Penn State’s active research enterprise. With $968 million in annual research expenditures, Penn State ranks in the top 25 of the nation’s public research universities.
The Pennsylvania State University, founded in 1855, is the Commonwealth of Pennsylvania’s sole land-grant institution and its largest public university. Penn State’s land-grant mission embraces teaching, research, and public service in order to support the citizens of the Commonwealth, collaborating with industrial, educational, and agricultural partners to create, disseminate, integrate, and apply knowledge that is valuable to society.