Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location:
This position is in the Human Research Protection Office. This position is for the Medical School Campus.
The Executive Director, Human Research Protection Office (HRPO) is responsible 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.
The Executive Director enhances the reputation of Washington University School of Medicine (SOM) as a leader in the advancement of basic and clinical research and provides guidance and support to investigators and research support staff to ensure the safety of human subject research participants as required by applicable laws, regulations and University policies regarding conduct of human subject research.
PRIMARY DUTIES AND RESPONSIBILITIES:
Working closely with the IRB Executive Chair to ensure that the operational and support functions for the IRB committees are provided and maintained.
Developing and managing the budget within department budget guidelines.
Overseeing 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.
Serving 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.
Providing 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.
Ensure appropriate documentation of IRB actions, and maintain records and correspondence related to IRB activity in accordance with applicable law and accreditation standards.
Utilizing 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.
Advising 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.
Organizing regular meetings of HRPO’s staff and leadership; develops meeting agenda and materials, takes and distributes minutes.
Gathering 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.
Supporting AAHRPP accreditation process and maintain AAHRPP accreditation status and reporting requirements. Supports the AAHRPP re-accreditation application and site visit processes.
Managing the institutional policy� on human subjects education and tracks certification of research personnel.
Reporting on monitoring, training and education, and conflict of interest disclosure to the IRB and/or the Research Compliance Committee as required.
Consulting 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.
Serving as steward of WU’s federal wide assurance (FWA); maintaining institutional assurances, registration and approvals needed for human research.
Managing 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.
Collaborating with the University’s research administration, quality and compliance offices on clinical research matters, as appropriate.
Collaborating with the University’s hospital partners, other academic research institutions and community organizations in managing human subjects research and maintaining good working relationships with those organizations.
Understanding the impact of any proposed regulatory changes on institutional policies pertaining to human subject research and implementing policy and procedure changes as appropriate.
Master's degree or higher and at least 5 years of experience directly related to the duties and responsibilities specified or Bachelor's degree with at least 7 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.
Prior experience utilizing the Single IRB model.
In depth understanding of laws, rules, and regulations governing human subject research including HIPAA regulations and Good Clinical Practice.
Working knowledge and understanding of biosafety policies and procedures preferred.
Exposure to international research projects is highly desirable.
Excellent organizational and project management skills.
Ability to work collaboratively with a diverse set of stakeholders and build effective interdisciplinary teams.
Excellent interpersonal and communication skills with the ability to develop and maintain effective working relationships with various constituencies, including leadership, faculty, students, administrators, members of the IRBs, clinical staff, and HRPO staff.
Excellent critical thinking, writing and editing abilities; adept at making data driven decisions.
Ability to develop and implement new policies and procedures, training and outreach.
Knowledge of enterprise research systems, databases and report generation.
Demonstrated ability to take initiative, identify, prioritize and plan activities necessary to meet goals.
Please attach a copy of your most current signed performance evaluation (completed within the last 18 months) to your online account. If you have not received a performance evaluation, you may provide two current signed letters of recommendation (written within the last 18 months), preferably to include one letter from either a current or recent former supervisor. To attach these documents, go to: My Career Tools, Add Attachment, Attachment Type – Performance Reviews or Letters of Recommendation.
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. Current employees applying for a new position within the university may be subject to this requirement. The screenings will include a criminal background check and, as applicable for the position, other background checks, drug screen, employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.
Washington University in St. Louis, a medium-sized, independent university, is dedicated to challenging its faculty and students alike to seek new knowledge and greater understanding of an ever-changing, multicultural world. The University offers more than 90 programs and almost 1,500 courses leading to bachelor's, master's and doctoral degrees in a broad spectrum of traditional and interdisciplinary fields, with additional opportunities for minor concentrations and individualized programs. The faculty is composed of scholars, scientists, artists and members of the learned professions. They serve society by teaching; by adding to the store of human art, creativity, understanding, and wisdom; and by providing direct services, such as health care.