Washington University in St. Louis invites applications and nominations for the position of Executive Director, Human Research Protection Office (HRPO) reporting to the Associate Dean for Research in the School of Medicine. The Executive Director is accountable for achieving the HRPO mission in protecting the rights, safety and welfare of individuals that participate in research. Key responsibilities include planning, developing and implementing processes, systems, educational programs and other activities necessary, in collaboration with other institutional research offices, to support Washington University Institutional Review Boards (IRBs).
The Executive Director also oversees the administrative support of HRPO including day-to-day operations, Full Board IRB Committee Review, Expedited Review, Protocol Adherence Review Committee, and maintaining the electronic IRB system. This position works to improve research outcomes by collaborating with other University research offices to promote clinical research education, training, policy development and quality assurance activities.
Essential Job Functions
Works closely with the IRB Executive Chair to ensure that the operational and support functions for the IRB committees are provided and maintained.
Develops and manages the budget within department budget guidelines.
Oversees administration and research compliance applicable to the Office for Human Research Protection Program (OHRP), Food and Drug Administration (FDA) regulations, federal funding agency requirements, state law and University policies during IRB and administrative reviews.
Serves as a resource to the University on research involving human subjects from a regulatory and ethical point of view. Acting as the primary liaison with federal and state agencies on human research protection issues.
Provides oversight for the ongoing work of the IRBs on human subject research including administrative operations, providing orientation and continuing education to IRB members and implementation of policies and procedures.
Ensures appropriate documentation of IRB actions, and maintain records and correspondence related to IRB activity in accordance with applicable law and accreditation standards.
Utilizes IRB data to provide strategic insight into human subject research at the University; preparing and submitting regular narrative reports related to IRB and HRPO activities to University leadership.
Advises the University research community on federal regulations and institutional policies and procedures to ensure institutional compliance with the ethical and regulatory requirements for human subject research. Working collaboratively with investigators to find creative ways to advance research goals while meeting compliance needs and challenges.
Organizes regular meetings of HRPO’s staff and leadership; develops meeting agenda and materials, takes and distributes minutes.
Gathers input on HRPO policies, drafts revisions, brings revisions to the leadership group for approval, and makes updates to the posted HRPO policy and procedure manuals.
Supports AAHRPP accreditation process and maintain AAHRPP accreditation status and reporting requirements. Supports the AAHRPP re-accreditation application and site visit processes.
Manages the institutional policy on human subject education and tracks certification of research personnel.
Reports on monitoring, training and education, and conflict of interest disclosure to the IRB and/or the Research Compliance Committee as required.
Consults with federal agency staff, as necessary, regarding the interpretation and implementation of guidelines. Interpreting and applying federal, state and local regulations, policies and procedures related to human subject research.
Serves as steward of WU’s federal wide assurance (FWA); maintaining institutional assurances, registration and approvals needed for human research.
Manages third party IRB reliance agreements and oversight of University research when deferred to central IRBs; assisting the IRB on overseeing studies deferred to the IRB.
Collaborates with the University’s research administration, quality and compliance offices on clinical research matters, as appropriate.
Collaborates with the University’s hospital partners, other academic research institutions and community organizations in managing human subject research and maintaining good working relationships with those organizations.
Understands the impact of any proposed regulatory changes on institutional policies pertaining to human subject research and implementing policy and procedure changes as appropriate.
Candidates may apply at: firstname.lastname@example.org job ID #44176. Please submit a resume along with a cover letter including a statement of interest. For more information you may contact Nancy Donohoo: email@example.com
Master's degree or higher and at least five years of experience directly related to the duties and responsibilities specified or Bachelor's degree with at least seven years of experience that is directly related to the duties and responsibilities specified.
At least three years of management experience; demonstrated experience with increasing responsibility in a human subject protection program. Biomedical and behavioral research experience is ideal.
Knowledge of AAHRPP standards and accreditation requirements; knowledge of HIPAA regulations and state laws governing privacy.
Working knowledge of scientific and medical concepts, terminology, and clinical care procedures and standards; working knowledge of good clinical/research practices and standards.
Prior experience conducting audits and investigations in a research setting.
Prior experience developing and implementing training and education (adult education) initiatives in a research setting.
Practiced negotiator and creative problem solver; adept at conflict resolution.
Prior experience working with commercial IRB committees.
Open and transparent approach to working with University stakeholders/departments requesting IRB information for compliance or business purposes.
Ability to manage competing priorities in a fast-paced environment.
Outstanding written and verbal communication skills.
CIP (Certified IRB Professional) or CIM (Certified IRB Manager) certification
High degree of familiarity with FDA Investigational New Drug (IND), Investigational Device Exemption (IDE) and Humanitarian Use Device (HUD) requirements.
Internal Number: 44176
About Washington University in St. Louis
Founded in 1853, Washington University is nationally and internationally renowned for teaching, learning, research, service to society, and patient care. The University is comprised of seven different schools: Arts and Sciences, Art and Architecture, Business, Engineering and Applied Sciences, Law, Medicine, and Social Work. The University has a total enrollment of 15,396 students, 3,819 faculty, and 15,474 employees (2017-2018). The medical school and allied health student population includes more than 1,400 students. Two thousand faculty members work in the School of Medicine as do 7,000 staff. Washington University’s graduate and undergraduate schools are highly ranked and the research profile of the institution is among the best in the nation. During the 2018 fiscal year, grants and contracts totaling more than $712M million supported faculty research efforts across the university.