Florida Gulf Coast University
Job Summary
The Manager, Institutional Review Board provides operational
oversight and management of the University's Institutional Review
Board and human subjects research review process. The position is
responsible for ensuring IRB operations, protocol review,
regulatory requirements, committee activities, and related
agreements and documentation comply with applicable federal, state,
institutional, and sponsor requirements. The position advises
researchers and institutional stakeholders on IRB requirements,
manages complex compliance matters, and supports continuous
improvement of IRB processes.
FGCU is building a culture of curiosity, commitment and
collaboration. We value employees who successfully work with others
and drive positive change through critical thinking and decisive
action. If you thrive in an environment of innovation,
accountability and mutual respect, you will find a good home
here.
Job Description
Typical duties may include but are not limited to:
- 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:
- Other duties as assigned.
Additional Job Description
Required Qualifications:
- 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.
Preferred Qualifications:
- 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.
Knowledge, Skills, and Abilities:
- 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.
Institutional Values & Behavioral Expectation
In this role, the successful candidate will be expected to:
- Seek out new approaches to improve outcomes; remain open for
feedback and new ideas.
- Lead with integrity; consistently produce high-quality work;
persevere to overcome obstacles to meet deadlines and achieve
deliverables.
- Share information and insights thoughtfully; build partnerships
across departments; communicate respectfully; support colleagues to
achieve common goals.
Pay Grade 18
Applications received prior to November 2, 2026, will receive
priority review.
FGCU is a State University System of Florida member and an Equal
Opportunity and Equal Access employer. All qualified applicants
will receive consideration for employment without regard to race,
color, religion, sex, age, national origin, disability, or
protected veteran status.
To apply, please visit: https://jobs.fgcu.edu/jobs/manager-institutional-review-board-fort-myers-florida-united-states
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