Research Foundation for Mental Hygiene, Inc. · 3 months ago
HRPP Assistant Director of Operations
The Research Foundation for Mental Hygiene is seeking a qualified applicant to fill a full-time Human Research Protection Program (HRPP) Operations Assistant Director role at the New York State Psychiatric Institute (NYSPI). The incumbent will provide lead and expert advice on operations and functions of the HRPP Office, supporting investigators and staff in navigating the regulatory and ethical complexities of human subject's research protections.
CharityHealth CareNon Profit
Responsibilities
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
Qualification
Required
Master's degree in a relevant field and (8) 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 (3) years of work experience where sophisticated knowledge of applicable legal, regulatory, and medical terminology was required
At least (3) 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 (3) 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
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
Benefits
Excellent Benefits Package
Company
Research Foundation for Mental Hygiene, Inc.
The Research Foundation for Mental Hygiene, Inc (RFMH) is a private, not-for-profit membership corporation organized in 1952, for the purpose of assisting and enhancing the research and training objectives of the New York State Department of Mental Hygiene and its component agencies; the Office of Mental Health (OMH), the Office for People with Developmental Disabilities (OPWDD) and the Office of Alcoholism and Substance Abuse Services (OASAS).
H1B Sponsorship
Research Foundation for Mental Hygiene, Inc. has a track record of offering H1B sponsorships. Please note that this does not
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2025 (36)
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Funding
Current Stage
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