Job Details
Title: Director of Human Research Protection Program
Company: Research Foundation for Mental Hygiene
Location: New York, NY
Job Title: Director, Human Research Protections Program
Grade: 37
Salary: $167,905 - $190,003
The Research Foundation for Mental Hygiene is seeking a qualified applicant to fill a full-time Director, Human Research Protections Program, position at the New York State Psychiatric Institute.
The mission of the NYSPI Human Research Protections Program (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 NYSPI 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 and RFMH 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.
Duties and Responsibilities:
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
Minimum Qualifications:
A./M.S. degree or equivalent related experience.
A minimum of seven years of experience, with supervisory or management experience, in a Human Research Protections Program setting at an academic medical center
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.)
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 and RFMH 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
Preferred Qualifications:
Certified IRB Professional (CIP) certification preferred.
Work Location: 1051 Riverside Drive, New York, NY 10032
To Apply: Submit an application through our website at https://nyspi.applicantpro.com/jobs/. Please note only applications submitted through our website will be considered.
To apply for this position or to learn more, please click "Apply Online" below.
SOCRA Exp: 6/1/2024
