Manager, Institutional Review Board

Florida Gulf Coast University•Lexington, MA

About The Position

The Manager, Institutional Review Board provides operational oversight and management of the University’s Institutional Review Board and human subjects research review process. The role ensures IRB operations, protocol review, committee activities, agreements, and documentation comply with applicable federal, state, institutional, and sponsor requirements. The manager advises researchers and institutional stakeholders, handles complex compliance matters, and supports continuous improvement of IRB processes. The position also supervises assigned staff and manages resources and activities that support effective and compliant IRB operations. The manager collaborates with Research Integrity, General Counsel, compliance, and other University offices on research compliance matters and supports the Research Integrity Officer or designee with research non-compliance and research misconduct matters, as assigned. Other duties may be assigned.

Requirements

Either nine years of directly related full-time experience, or a bachelor’s degree from an accredited institution in an appropriate area of specialization and five years of full-time experience directly related to the job functions.
Seven years of full-time experience in research administration or IRB programs.
Experience operating a personal computer and proficiency with Microsoft Office, including Word, Excel, and Outlook.
Knowledge of policies, procedures, and regulations pertaining to the position.
Knowledge of supervisory principles, methods, and techniques.
Excellent organizational, time-management, and problem-solving skills.
Skill in identifying complex problems, reviewing related information, developing and evaluating options, and implementing solutions.
Ability to plan, organize, coordinate, and perform work amid numerous and competing demands.
Ability to collaborate and work effectively within the community and contribute to a team effort.
Detail orientation and ability to work independently.
Ability to interact professionally with staff, faculty, students, and the community in a service-oriented environment.
Ability to work in a team and with all levels of employees.
Ability to plan and delegate work effectively.
Ability to manage others’ work by providing information, guidance, and motivation.
Ability to think strategically and approach challenges creatively.
Reliability, accountability, and a demonstrated record of meeting goals.
Strong interpersonal skills and experience working effectively across teams.

Nice To Haves

Master’s degree from an accredited institution in an appropriate area of specialization.
Experience with all aspects of grant management.
Experience with Workday and web-based databases such as Salesforce.
Any appropriate combination of relevant education, experience, and/or certifications may be considered.

Responsibilities

Provide leadership and operational oversight of the IRB, including protocol submission and review, committee activities, meeting operations, and related documentation.
Ensure compliance with applicable federal regulations, including 45 CFR 46 and 21 CFR 56, Federalwide Assurance (FWA) requirements, IRB registration requirements, and applicable state, institutional, and sponsor requirements.
Manage reliance agreements, multi-site research arrangements, and other agreements supporting the University’s human subjects research activities.
Develop, update, and implement IRB policies, standard operating procedures, guidance, and processes.
Advise faculty, researchers, staff, and administrators on IRB requirements, protocol preparation and submission, required training and certifications, and University policies and procedures.
Review protocols and related documentation for regulatory, institutional, ethical, and sponsor-specific compliance; coordinate resolution of deficiencies and complex issues.
Plan and coordinate quality assurance activities, institutional audits, and post-approval monitoring.
Provide education on IRB processes, human subjects research requirements, and responsible conduct of research, including serving as the primary research liaison for CITI human subjects training.
Collaborate with Research Integrity, General Counsel, compliance, and other University offices on research compliance matters.
Support the Research Integrity Officer or designee with research non-compliance and research misconduct matters, as assigned.
Communicate with external agencies and regulatory entities regarding IRB and human subjects research compliance.
Identify, evaluate, and resolve complex IRB operations and human subjects research compliance issues; recommend process improvements.
Supervise assigned staff and manage resources and activities necessary for compliant IRB operations.
Perform other duties as assigned.