Director, Institutional Review Board (remote)

Northwell•Manhasset, NY

14d•Remote

About The Position

Directs, plans, and organizes the staff and activities of the institutional review board (IRB). Provides day-to-day operational oversight of the Research Intelligence Institutional Review Board (IRB). This individual oversees the research protocol submission and review process. Oversees work of IRB Analysts and IRB coordinators, ensuring the consistency of IRB minutes, review, and communication practices. Serves as a content area expert and resource on matters related to human subjects’ research program policies, procedures, and activities. The Director serves as the primary point of contact for study team leadership as well as all relying site investigators. Facilitates IRB review of both study-wide and site-specific submissions. Manages Full board, expedited, and exempt review processes. Creates and manages quality improvement metrics for the IRB that is based on national guidelines and accreditation practices. Generates reports to federal agencies as needed.

Requirements

Bachelor's Degree required, or equivalent combination of education and related experience.
8-12 years of relevant experience and 7+ years of leadership / management experience, required.

Nice To Haves

Exceptional organizational skills and attention to detail.
Excellent communication skills, both oral and verbal.
Ability to maintain a high level of professionalism and confidentiality.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Ability to adapt to a fast-paced environment and manage changing priorities.
A proactive problem-solver with strong critical thinking skills.
Detail-oriented with the ability to multi-task and prioritize workload.
Certified IRB Professional (CIP) expected, or within one year of job acceptance.

Responsibilities

Leads an Institutional Review Board group by communicating with and developing staff members, and building consensus for programs and goals that support a business, function or geographic area.
Develops and articulates a short-term strategic vision for areas of responsibility.
Oversees and reviews new and continuing research programs to ensure compliance with IRB standards and policies.
Evaluates and makes recommendations for improvement and efficiencies regarding IRB operational procedures and policies.
Oversees the development and implementation of computerized information systems and resources.
Advises Investigators and other research staff of appropriate conduct of research, preparation of protocol and consent documents in accordance with applicable regulations and reporting requirements for human subject research.
Prepares reports for federal and state agencies regarding IRB decisions and research compliance issues as required by regulation.
Collaborates with research and corporate compliance in identifying “for cause” audits and problem resolution.
Selects, develops, manages and evaluates direct reports and oversees the development, management and evaluation of indirect reports.
Evaluates, recommends and implements educational programs for staff and the research community.
Serves as a liaison to federal and NY State agencies and committees, which regulate human subject research.
Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.
Provides regulatory guidance to IRB members, Chair, and critical stakeholders as needed.
Meets with senior leadership and core stakeholders to address critical concerns of the IRB office.
Assess and adjust the operations of the IRB as needed.
Drafts communications IRB determinations that impact on local, state, or federal law.
Monitor operations of the IRB staff to ensure timely, reliable, and consistent ethical review
Monitors, evaluates, and works with critical stakeholder regarding updates needed to the HRPP, IRB, and educational needs of the IRB Committee, research community, and IRB staff
Conducts non-committee review for submissions as determined by local policy
Researching, developing, and conducting continuing education opportunities for research community, ensuring continual and up to date awareness of the federal regulations which govern human subjects research
Continuously evaluate and improve IRB processes and procedures
Deliver high-quality service
Builds and provides regulatory expertise, guidance, and administrative support with empathy, reliability, and professionalism.
Represents the IRB and the institution at conferences and events related to research compliance and human subjects research protections
Maintains current working knowledge of the regulations for the safety and protection of human subjects in research and stays current of any changes to the regulatory landscape that may affect the research community