Grade: 33
Salary: $137,681- $163,254
The Research Foundation for Mental Hygiene is seeking a qualified applicant to fill a full-time Human Research Protection Program (HRPP) Operations Assistant Director position for the Division of Facilities and Administrative at the New York State Psychiatric Institute (NYSPI). Reporting to the NYSPI HRPP Director, the incumbent will provide lead and expert advice and guidance on operations and functions of the HRPP Office and support investigators and HRPP Office staff in navigating the regulatory and ethical complexities of human subjects research protections, including adherence to all federal, state, and local requirements and principles of the Belmont Report.
Note: This is a hybrid role with 50% on-site requirement.
Duties And Responsibilities
Responsibilities include, but are not limited to:
- Manage HRPP Office staff, including recommendations for hiring, disciplinary action, coaching, training, and mentoring.
- Provide direction and feedback to staff or teams to ensure accurate, efficient, and compliant completion of assignments and other activities.
- Prepare and escalate regular reports on individual and team performance, compliance, quality measures, and other relevant information.
- Contribute to departmental and cross-departmental initiatives and projects, including policy drafting and editing; assist in the development and revision of HRPP policies, guidance, and standard operating procedure documents.
- Perform, manage, or assist with the duties of the Institutional Review Board (IRB) Office and Quality Improvement and Education team.
- Oversee or assist with regulatory matters, including applying ethical principles and standards for the protection of human research participants.
- Manage or support reliance activities, including building of the NYSPI IRB Reliance program.
- Work with the IRB Reliance Director to ensure accuracy and completeness of all reliance agreements and ensuring that all local context requirements are addressed when relying on an external IRB.
- Manage or support compliance activities, such as audits, reportable new information, and agency inspections.
- Oversee or assist with quality-related activities, including quality control, assurance, and improvement.
- Handle or assist with operational tasks, including providing feedback on HRPP initiatives.
Facilitate or assist with activities related to relationships external to the HRPP Office and the Institute. - Address compliance-related inquiries and provide expert guidance and interpretation of applicable regulatory and institutional requirements.
- Perform other duties as assigned.
Minimum Qualifications
- Master’s degree in a relevant field and eight or more years of research-related experience at a large academic institution, hospital/medical center, academic/institutional IRB, non-profit organization/foundation, federal department or agency, or corporate/industry environment or an equivalent combination of education and experience.
- At least three years of work experience where sophisticated knowledge of applicable legal, regulatory, and medical terminology was required
- At least three years of work experience where expertise in interpreting, analyzing, applying, and communicating applicable ethical principles, standards, regulations, guidance, policies, and academic and industry trends that impact human research was required.
- At least three years of work experience where effectively interacting and collaborating with a broad spectrum of individuals including faculty, patients, participants, researchers, administrators, students, agency representatives, and other professional contacts was required.
- Preferred Qualifications
- At least (2) years with direct responsibility and oversight of policy development and implementation, including duties related to reliance agreements and arrangements.
- Experience supervising large teams and engaging in team building initiatives.
- Direct experience in building and/or operation of a large-scale IRB Reliance Program.
- Direct working experience with federal regulatory office or body.
- Proven ability to manage and process a large volume of complex work by prioritizing and organizing work and demonstrating flexibility and willingness to adjust priorities as necessary.
- Strong software applications and technology skills and demonstrated ability to learn new software packages and leverage technological solutions.
Work Location: 1051 Riverside Drive, New York, NY 10032