This position is responsible for overseeing the day to day operations of the Research Integrity Office. This includes serving as chief administrative and programmatic support for the Research Integrity Office's oversight committees including the Institutional Review Board (IRB), Data Safety Monitoring Board (DSMB), Conflict of Interest in Research Committee (COIR), Institutional Biosafety Committee (IBC) and the Institutional Animal Care and Use Committee (IACUC). The Mgr, Rsrch Integrity Office establishes and maintains research integrity/compliance systems, including policies, procedures, and training; sets the vision and goals for ensuring alignment with those of HMH Human Resource Protection Program (HRPP) and AAHRPP standards.
Responsibilities Oversees the daily activities and manages staff of the Research Integrity Office including the use of humans in research, use of animals in research, conflicts of interest, DSMB, and responsible conduct in research. Maintains accreditation standards and ensures metrics are collected to reflect standards.
Ensures records maintained in the electronic system are accurate and complete; responsible for compiling monthly reports for Director to review accuracy. Provides oversight and training in IRB policies and procedures to assigned IRB staff. Serves as an official designee as needed on the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC) and Institutional Biosafety Board (IBC). As a voting member of above listed committees, reviews assigned protocols and attends meetings.
Identifies needs and drafts guidelines and policies pertaining to research integrity/compliance. Coordinates the development and delivery of educational sessions for the research community on integrity/compliance policies and procedures, including the production of educational materials attending training sessions, and making classroom presentations. Serves as a resource and channel of communication for individuals reporting research integrity/compliance concerns.
Investigates allegations of non-compliance, as needed. Facilitates random, for-cause or committee requested audits of research activities to ensure quality control, compliance with regulations or IRB requirements, and ensures appropriate human subjects protections are followed/in-place. Recruits and interviews prospective board members, supervises training and orientation of new members to the technical and ethical and ethical literature, appropriate policy, statues, regulations, and duties as board members.
Ensure human research protection training is available and completed by investigators, key study personnel, the Institutional Signatory Official, and all staff who participate in the human subjects protection program. Evaluates workload for research boards and informs senior administration of adequate staffing levels and resources as per federal assurance requirements and amends budget accordingly. Serves a key role on the Network Research Compliance meeting, providing key information as to the metrics for both internal and external IRB's.
Assists Director with special projects as assigned to ensure excellence in upholding accreditation standards and implementing best practices. Qualifications Bachelor's Degree is required Expert knowledge of compliance regulations in at least one area of research; demonstrated experience working within at least one additional compliance area other than the one required (mentioned earlier within this bullet). Experience and participation in investigations in compliance areas. Demonstrated organizational, analytical, leadership, team-building, writing, presentation and problem-solving skills.
Ability to accommodate and respond to shifting priorities and multiple, demanding projects, in a manner that is effective and efficient. Minimum of five-year's experience working in the field of research compliance/integrity or an equivalent combination of education and experience which totals five years or more. Ability to learn Federal and State regulations, administrative procedures, and effectively communicate these regulations to faculty, staff and students, both verbally and in writing.
Traits include Creativity and initiative. Able to conceptualize, plan and implement programs that support research, and ensure accountability and compliance.
Hackensack University Medical Center