IRB/IBC Compliance Coordinator
Position Type
Professional Staff
Faculty Track
Employment Status
Full Time
Months
12
Campus
Both ME Campuses
Description
The Institutional Review Board (IRB) and the Institutional Biosafety Committee (IBC) Compliance Coordinator reports directly to the Director of Human Protections and Biosafety and provides administrative and regulatory support to the UNE research community, IRB, and the IBC. The Coordinator facilitates submission intake and pre-review, supports committee operations, maintains official records, and communicates review requirements and determinations to researchers. This position offers an opportunity to develop specialized expertise in human research protections, research ethics, and biosafety oversight.
About the University of New England
UNE is Maine's largest private university, with two beautiful coastal campuses in Maine, a one-of-a-kind study-abroad campus in Tangier, Morocco, and an array of flexible online offerings. In an uncommonly welcoming and supportive community, we offer hands-on learning, empowering students to positively impact a world full of challenges. We are the state's top provider of health professionals and home to Maine's only medical and dental colleges, a variety of other interprofessionally aligned health care programs, and nationally recognized programs in the marine sciences, the natural and social sciences, business, the humanities, and the arts.
Benefits Overview

• Multiple health and dental plan options, plus vision coverage.
• Up to 8% retirement plan match.
• Generous leave time, including vacation, sick, and personal time, and 12+ holidays per year.
• Educational benefits:
  • UNE tuition waiver for employees, spouses, and domestic partners.
  • UNE tuition waiver for dependents of employees with 1 year of full-time service.
  • 50% tuition reduction if less than 1 year of full-time service.
  
  

For more information about our outstanding benefits, please visit: UNE Benefits Overview
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.

Qualifications
Required

• 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 escalate questions when appropriate.

Preferred

• One to two years of experience in research administration, research compliance, regulatory compliance, or a related field.
• Experience supporting an IRB, IBC, IACUC, or another research oversight or regulatory program.
• Familiarity with electronic research administration or protocol-management systems.
• Experience preparing formal correspondence, meeting minutes, or regulatory records.
• Familiarity with human research protections, biosafety oversight, or research ethics.

EEO Statement Summary
Consistent with federal and state law and University policy, the University of New England is committed to the fundamental concept of equal opportunity for all of the members of the University community. The University prohibits, and will not tolerate, discrimination in employment, the provision of academic services or in any other area of University life based on race, color, sex, physical or mental disability, religion, age, ancestry, national origin, sexual orientation, gender identity and/or expression, ethnicity, genetic information, HIV status, or status as a veteran. Prohibited bias factors should not motivate decisions regarding students, employees, applicants for admission, applicants for employment, contractors, volunteers or participants in and/or users of institutional programs, services, and activities.
COVID Vaccination Statement (PLEASE NOTE)
Posting Number
2022PS0982P
Close Date
Open Until Filled
To apply, visit https://une.peopleadmin.com/postings/26716
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