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HRPP Assistant Director of Operations

HRPP Assistant Director of Operations

New York State Psychiatry InstituteNew York, NY, US
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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). 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 subject's 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 :

  • 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 (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 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

    To Apply : Submit an application through our website at https : / / rfmh.applicantpro.com / jobs / . Please note only applications submitted through our website will be considered.

    The Mission of the Research Foundation for Mental Hygiene, Inc. (RFMH) is to promote the mental health of all New Yorkers, with a focus on providing hope and supporting recovery for adults with serious mental illness and children with serious emotional disturbances. Applicants with lived mental health experience are encouraged to apply. RFMH is deeply committed to supporting underserved individuals, organizations, and communities. To this end, RFMH is focused on implementing activities and initiatives to reduce disparities in access, quality, and treatment outcomes for underserved populations. A critical component of these efforts is ensuring that RFMH is a diverse and inclusive workplace where all employees' unique attributes and skills are valued and utilized to support the mission of the Agency. RFMH is an equal opportunity / affirmative action employer.

    The Research Foundation is a private not-for-profit corporation and is not an agency or instrumentality of the State of New York. Employees of the Research Foundation are not state employees, do not participate in any state retirement system, and do not receive state fringe benefits. Excellent Benefits Package. Affirmative Action / Equal Opportunity Employer - Disabled / Veteran, 41 CFR 60-741.5(a) and 41 CFR 60-300.5(a) compliant.

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