About the position

This individual will manage all IRB reviews under the auspices of the Northwell Health Research Intelligence Institutional Review Board (IRB) and will oversee all IRB responsibilities related to newly implemented clinical research for Northwell. Additionally, this individual will review nonclinical trial, expedited or exempt research, as needed. The incumbent will specialize in concepts associated with FDA regulations and the research protocol review and submission process to ensure compliance with local, state, and federal regulations and guidance. The IRB analyst will assist researchers, staff, and other stakeholders with drafting and editing protocols and consent forms and interprets regulations when analyzing research submissions to identify research requirements. Conducting in-depth pre-reviews and drafting meeting minutes will be required. This individual provides feedback to investigators and research staff to guide them in making necessary modifications to submissions in order to meet applicable institutional, regulatory, and other requirements for obtaining approval and maintaining compliance with committee guidance.

Responsibilities

• Analyzes, verifies, tracks and performs preliminary administrative review of items referred to IRB and communicates deficiencies or questions to investigators; assists in preparation of reports and correspondence related to IRB activities.
• Reviews proposed research for compliance with federal, state and local regulations; determines category of review and assess risk; evaluates need for further clinical or professional review of research.
• Provides support to investigators by assuring the accuracy of submissions and modifications; responds to investigators regarding deficiencies, inconsistencies or concerns.
• Monitors continuing review of research for compliance; identifies and reports items of concern for further action.
• Maintains accurate records, including database management; provides assistance in the performance of internal quality improvement activities.
• Assists in facilitating and recording IRB meeting minutes and review activities.
• Conducts and documents expedited IRB reviews of human subjects’ research.
• Supports investigators in developing the IRB submissions for human subject research projects.
• Operates under general guidance and work assignments are varied and require interpretation and independent decisions on course of action.
• 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.
• Manages personal and shared inbox to ensure prompt response to stakeholder concerns
• Escalates matters of concern to the Senior IRB Director or IRB Manager as appropriate
• Provides regulatory guidance to IRB members, Chair, and critical stakeholders as needed.
• This individual has the primary responsibility of moving submissions through the office workflow in a timely manner, ensuring that submissions are review-ready prior to routing for committee review, conducting certain non-committee reviews, and generating correspondence after the review process is complete along with coordinating the activities of IRB
• Coordinates regular IRB meetings and arranges ad Hoc meetings with the assistance of the IRB project manager, as needed, ensuring appropriate timing and preparation.
• Evaluates all submission materials to determine consistency with IRB requirements for approval, including all local policies, applicable federal, state and local law and Good Clinical Practices
• Maintains quorum during IRB meetings
• Ensures appropriate communication of meeting determinations and timely follow up for all internal and external stakeholders
• Works with senior leadership to draft communications, as needed, for internal and external communication of IRB determinations that impact on local, state, or federal law.
• Conducts pre-review to ensure that submissions are review ready, routes submissions appropriately for either non-committee or committee review, and communicates review results to investigators and others as needed
• Prepares for, coordinates and facilitates IRB Committee meetings, which includes, but is not limited to: Preparing submissions for review by the convened IRB, Assigning reviewers to submissions, Managing IRB meeting agenda volume, Confirming IRB member meeting attendance to ensure quorum, Monitoring quorum during IRB meetings, Documenting determinations made by the convened IRB, Generating IRB meeting minutes and correspondence
• Provides feedback to leaders regarding updates/edits needed to the HRPP, IRB functions, and educational needs (deficiencies) of the IRB Committee, research community, and IRB staff
• Identifies issues that arise within work processes and escalate to team leadership.
• Maintains organization of documents for audit and accreditation
• 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
• Delivers high-quality service
• Provides regulatory expertise, guidance, and administrative support with empathy, reliability, and professionalism.
• Performs general administrative duties and event organization as needed.

Requirements

• Bachelor's Degree required, or equivalent combination of education and related experience.
• Minimum 2 years experience in research administration, 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).
• Proficient in procedures associated with IRB record keeping and documentation.
• 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 after two years in the job based on certification requirements