New York State Psychiatry Institute
  • 15-Jul-2022 to Until Filled (EST)
  • PI- Adult Psychiatry
  • New York, NY, USA
  • per year
  • Salary
  • Full Time

Full Benefits package based on percentage of full-time effort.


Grade 37

Salary Range: $158,354 - $190,120


The Research Foundation is seeking a qualified candidate to fill the full-time position of Director of the New York State OMH Human Research Protection Program.


The HRPP

The mission of the HRPP is to promote the welfare and rights of human research participants, to facilitate excellence in the conduct of all human research activities regardless of regulatory risk, and to provide timely and high-quality IRB review, monitoring of ongoing human studies, and ongoing education and training of investigators and HRPP staff. The HRPP assists NYSPI, RFMH and OMH in meeting their regulatory and ethical obligations pertaining to human research participants, and routinely collaborates with other institutional offices.


The HRPP Director

The HRPP Director has leadership authority over all employees who support and serve the research protection mission and activities of the HRPP. The HRPP Director coordinates HRPP activities across the various offices and staff within NYSPI, RFMH, and OMH that have roles in protecting human research participants. The HRPP Director is tasked with the management and oversight of all research protection activities including compliance reporting, data security and privacy protection (HIPAA), monitoring of approved research studies, education and training of IRB personnel and research investigators, HRPP policy development (including IRB policy and procedures, and ethics advisory board policy development), and IRB operations pertaining to the review and approval of research.


Key responsibilities of the HRPP Director include:


  • Ensuring compliance with the OHRP Federal Wide Assurance (FWA)
  • Providing guidance to the IRB, researchers, research staff, and administrators regarding the interpretation and application of regulations, laws, and policies
  • Developing, updating and implementing IRB policies and procedures
  • Ensuring that comprehensive human research protection training and HIPAA training are available and completed by investigators, key study personnel, the Institutional Signatory Official, and all employees who participate in the HRPP
  • Overseeing the quality assurance/quality improvement and monitoring functions of the HRPP, including for-cause audits of research protocols and investigation of potential non-compliance. Ensuring implementation of corrective action as needed, in accordance with institutional policies and procedures and federal and state regulatory requirements
  • Maintaining updated knowledge of human research protection guidance and regulations as they evolve. Staying current on emerging challenges. Monitoring federal regulatory websites (NIH, FDA) and other research-related resources to stay current with regulatory changes in human research protections guidelines and policies. Communicating pertinent information to staff and to institutional leadership in a timely manner.

Qualifications

  • Bachelor's degree required, master's or graduate degree (i.e., J.D., Ph.D., MD) preferred
  • Minimum five years leadership and/or management experience in HRPP/IRB activities; Certified IRB Professional (CIP) certification preferred.
  • Excellent verbal and written communication skills including ability to resolve conflicts amongst HRPP stakeholders
  • Professional experience and sound judgment to comprehend, interpret and analyze publications and reports concerning federal and NY human research protection policies, procedures, regulations, and laws
  • Demonstrated understanding of federal regulations and agency guidelines for human subjects, including HHS, FDA, HIPAA, FERPA, and other agency specific regulations (such as DOD, DoED, NIH, etc.)
  • Detailed working knowledge of regulatory requirements for the protection of human subjects of biomedical and behavioral research
  • Managerial experience and proven success in managing an Institutional Review Board
  • Proven leadership and management skills, including establishing and measuring goals and objectives, optimizing and monitoring work assignments, facilitating career development and staff retention
  • Ability to formulate broad policy recommendations for NYSPI, RFMH or OMH regarding human research protection issues, including educational and training requirements for IRB members, staff, and investigators
  • Ability to apply flexibility and creativity to a complex array of compliance issues
  • Skill in establishing relationships with human subjects' regulatory agencies on state and federal level
  • Excellent analytical and independent problem-solving skills, organizational, coordination and prioritization skills
  • Ability to synthesize information from multiple sources to produce succinct, detail-oriented, and accurate documents, policies, reports, and announcements



RFMH employees may be required to be vaccinated for COVID-19 depending on work location and must provide proof of vaccination. Individuals that are not vaccinated for COVID-19 are ineligible for appointment to positions that require vaccination. Fully vaccinated is defined as two (2) or more weeks since receiving either the second dose in a two-dose COVID-19 vaccination series (e.g., Pfizer-BioNTech or Moderna) or the first and only dose of a single-dose vaccine (e.g., Johnson & Johnson [J&J]/Janssen).


Work Location: 1051 Riverside Drive, New York, New York 10032

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


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. Employer/Minority/Women/Disabled/Veteran Employer. VEVRAA 41 CFR 60-300.5(a) compliant.





New York State Psychiatry Institute
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