IRB/IBC Compliance Specialist - Research Ethics & Oversight

University of New England; Biddeford (ME); On-site; USD 56,000 - 75,000; Full time

Job summary

University of New England seeks an Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) Compliance Coordinator who reports to the Director of Human Protections and Biosafety. The role provides administrative and regulatory support to the UNE research community, IRB, and IBC, facilitates submission intake and pre-review, and maintains official records.

You will communicate review determinations to researchers, support committee operations, schedule meetings, and assist

Qualifications

• Bachelor’s degree or an equivalent combination of education and relevant experience.
• Demonstrated administrative, regulatory, research, or compliance experience.
• Excellent organizational, written, and interpersonal communication skills.
• Demonstrated attention to detail and ability to maintain complete and accurate records.
• Ability to review detailed information, identify inconsistencies or omissions, and apply established policies and procedures using sound judgment.
• Ability to manage multiple priorities and meet established deadlines.
• Proficiency with Microsoft Outlook, Word, Excel, BOX, and Adobe Acrobat or comparable applications.
• Ability to exercise discretion and maintain confidentiality when handling sensitive information.
• Ability to work independently and collaborate effectively with researchers, committee members, and colleagues across the University.
• Intellectual curiosity and willingness to seek clarification and elevate questions when appropriate.

Responsibilities

• Monitor the IRB and IBC general mailboxes and provide timely, professional responses to researchers and other stakeholders.
• Log and track new applications, resubmissions, amendments, reports, and other submissions in designated tracking systems.
• Conduct pre-reviews of incoming submissions for completeness and consistency with applicable requirements; request missing information, clarifications, or revisions from researchers.
• Review and process eligible administrative IRB and IBC submissions and exempt IRB submissions in accordance with institutional policies, procedures, and delegated authority.
• Collaborate with the IRB and IBC Chairs to assign submissions requiring committee-member review.
• Provide researchers with procedural guidance regarding IRB and IBC submission requirements, review processes, forms, and institutional resources; refer complex regulatory or policy questions to the Director or appropriate committee Chair.
• Maintain complete, accurate, and current IRB and IBC protocol and committee records.
• Track protocol approval periods, reporting deadlines, and required follow-up activities; send reminders regarding continuing review, renewals, progress reports, or other required submissions, as applicable.
• Prepare approved study documents and draft or issue determination letters and related correspondence, as authorized.
• Schedule and coordinate IRB and IBC meetings and prepare and maintain agendas, minutes, attendance records, and supporting materials.
• Assist with routine regulatory documentation, reports, registrations, and related filings.
• Safeguard confidential and sensitive research, committee, and compliance information.
• Identify and refer potential compliance concerns or other matters requiring further review to the Director.
• Support the development and maintenance of guidance materials, forms, templates, and standard communications.
• Assist with researcher outreach, education, and training activities.
• Coordinate or provide administrative leadership for special projects assigned by the Director.
• Perform other related duties as assigned.

Skills

Administrative coordination

Regulatory compliance

Communication skills

Documentation & record-keeping

Attention to detail

Time management

Microsoft Office

Confidentiality

Independent working

Education

Bachelor’s degree or equivalent

Tools

BOX

Adobe Acrobat

Job description

University of New England seeks an Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) Compliance Coordinator who reports to the Director of Human Protections and Biosafety. The role provides administrative and regulatory support to the UNE research community, IRB, and IBC, facilitates submission intake and pre-review, and maintains official records.

You will communicate review determinations to researchers, support committee operations, schedule meetings, and assist