[Remote] Manager, Institutional Review Board

Note: The job is a remote job and is open to candidates in USA. Florida Gulf Coast University seeks a Manager, Institutional Review Board to oversee the University’s IRB operations and human subjects research review process. The role ensures regulatory and institutional compliance, advises researchers, manages committee activities and agreements, and leads staff and process improvements.

Responsibilities

• Provides leadership and operational oversight of the IRB, including the protocol submission and review process, committee activities, meeting operations, and related documentation
• Ensures compliance with applicable federal regulations, including 45 CFR 46 and 21 CFR 56, Federal wide Assurance (FWA) requirements, IRB registration requirements, and applicable state, institutional, and sponsor requirements
• Manages reliance agreements, multi-site research arrangements, and other agreements supporting the University’s human subjects research activities
• Develops, updates, and implements policies, standard operating procedures, guidance, and processes related to IRB operations and human subjects research requirements
• Advises faculty, researchers, staff, and administrators regarding IRB requirements, protocol preparation and submission, required training and certifications, and applicable University policies and procedures
• Reviews protocols and related documentation to ensure compliance with regulatory, institutional, ethical, and sponsor-specific requirements and coordinates resolution of deficiencies and other complex issues
• Plans and coordinates quality assurance activities, institutional audits, and post-approval monitoring to support ongoing compliance with human subjects research requirements
• Provides training and education to researchers, faculty, and staff regarding IRB processes, human subjects research requirements, and responsible conduct of research, including serving as the primary research liaison for CITI training for human subjects
• Collaborates with Research Integrity, General Counsel, compliance, and other University offices to address research compliance matters and supports the Research Integrity Officer or designee with research non-compliance and research misconduct matters, as assigned
• Maintains communication with external agencies and regulatory entities regarding IRB and human subjects research compliance matters
• Identifies, evaluates, and resolves complex issues related to IRB operations and human subjects research compliance and recommends improvements to processes and practices
• Supervises assigned staff and manages the resources and activities necessary to support effective and compliant IRB operations
• Other duties as assigned

Skills

• This position requires either nine years of directly related full-time experience or, as an alternative, 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, full-time experience in research administration or IBR programs
• Experience operating a personal computer and proficient with Microsoft Office (Word, Excel, and Outlook)
• Any appropriate combination of relevant education, experience, and/or certifications may be considered
• Proven ability to think strategically and approach challenges with creativity
• Demonstrated track record of reliability, meeting goals, and holding oneself accountable
• Strong interpersonal skills and experience working effectively across teams
• 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 and reviewing related information to develop and evaluate options and implement solutions
• Ability to take initiative to plan, organize, coordinate and perform work in various situations when numerous and competing demands are involved
• Ability to collaborate and work effectively within the community and willing to contribute to a team effort
• Detail oriented and the ability to work independently
• Ability to interact in a professional manner 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 effectively plan and delegate the work of others
• Ability to effectively manage the work of others by providing information, guidance and motivation
• 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

Company Overview

• Florida Gulf Coast University is a school in Fort Myers. It was founded in 1991, and is headquartered in Fort Myers, Florida, USA, with a workforce of 1001-5000 employees. Its website is http://www.fgcu.edu/.

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