Senior IRB Analyst

Posting Details

Position Information

Job Title Senior IRB Analyst Position Number 500684 Vacancy Open to All Candidates Department AAH REDE Institutional Review Board Department Homepage https://rede.ecu.edu/umcirb/ Advertising Department RESEARCH, ECONOMIC DEVELOPMENT AND ENGAGEMENT Division Academic Affairs Classification Title Specialist Working Title Senior IRB Analyst Number of Vacancies 1 Full Time Equivalent (FTE) 1.0 Full Time or Part Time Full Time Anticipated Recruitment Range. Salary offered may be outside of this range as impacted by budget, UNC salary administration, and/or candidate qualifications. $41,379 - $69,500 Position Location (City) Greenville Position Type Non-Faculty Job Category Non-Faculty Professional Organizational Unit Overview

Academic Affairs ("AA") is headed by the Provost and Vice Chancellor for Academic Affairs who serves as the institution's Chief Academic Officer ("CAO") and is responsible for administering academic policies. AA is comprised of each of the university's colleges, schools, and libraries, along with other academic support and administrative units, to include Learner Operations, Research, Economic Development and Engagement (REDE), Institutional Planning, Assessment and Research, and Global Affairs. Academic Affairs works collaboratively to strengthen ECU's culture of academic excellence in line with our mission to be a national model for student success, public service, and regional transformation.

REDE is responsible for providing resources, advocacy, education and support to elevate and advance East Carolina University's research community and advancing the institution's public service and economic engagement agenda. The Senior Vice Provost for Research and Innovation leads REDE and is a direct report to the Provost. Two teams comprise REDE. The Office of Research is focused on research and the Office of Industry and Engagement focuses on industry, national security, economic and community development, and continuing and professional education.

The Office of Research provides oversight of ECU's research enterprise including grant administration and ethical conduct of research; ensures compliance with the federal, state, and University rules and regulations; and supports technology transfer and commercialization. The office includes Pre-Award Services, Post-Award Services, Research Integrity and Compliance, Compliance Monitoring, Research Administration Analytics, Research Development, Institutional Animal Care and Use Committee, the University Medical and Behavioral Institutional Review Board, and the Office of Licensing and Commercialization. The Coastal Studies Institute (CSI) will also report within REDE. CSI is a collaborative, interinstitutional research, education, and outreach center led by East Carolina University.

In addition, The Office of Industry and Engagement collaborates with departments and colleges/schools across the University to amplify the university's service to and economic impact on North Carolina. This unit is the frontline resource for development and maturing of partnerships with entities in industry, state and local government, military agencies, nonprofit and faith-based organizations, and other regional stakeholders. The purpose of these partnerships is to create research and learning opportunities that bring ECU faculty, staff, and students together with external partners to benefit the university and helps advance mutually beneficial community and economic development interests. This office provides strategic leadership for engagement, outreach, public service, and economic development activities, ensuring all align with the university's mission and values. These activities are supported through various funding sources including state appropriations, grants, contracts, continuing education programs, and philanthropic donors.

East Carolina University is also a regional university hub of NC Innovation (NCI). The Eastern Region NCI Hub is housed within the Office of Industry and Engagement and its director works closely with the Senior Vice Provost for Research and Innovation and other campus leaders to guide the partnership between NCI and the University.

Job Duties

The primary purpose of the Senior IRB Analyst for the Institutional Review Board is to support the overall administration of the human research review and approval process with a specific emphasis on IRB reliance and single IRB (sIRB) oversight. This position serves as the institutional subject-matter expert for IRB reliance models, providing high-level regulatory guidance to investigators, IRB members, and institutional partners involved in multi-site and collaborative research. The Senior IRB Analyst manages reliance determinations, coordinates IRB authorization agreements, and supports institutional responsibilities when ECU serves as the reviewing IRB or relies on an external IRB. Through these efforts, the position ensures compliance with institutional SOPs and applicable international, federal, state, and local regulations, while advancing efficient and ethical conduct of human research.

The Senior IRB Analyst will be responsible for screening and processing human research applications in accordance with human research related regulations, rules, and policies. This position will aid all customers and will analyze and interpret complex regulations, rules, and guidance related to human research to serve as a process expert. The Senior IRB Analyst will effectively communicate, both written and verbally, and serve as a dependable resource for a wide variety of customers. This position will also understand and support the technology required for conducting daily business.

This position requires interpretation of federal regulations and guidance and evaluating human research application received by the UMCIRB. The position will work closely with other staff, investigators with varying levels of experience, and administrative leaders to support the human research enterprise.

UMCIRB Coordination and Support - 40%:

• Serve as a primary contact for local investigators conducting human research in the screening and development of their proposals to ensure IRB regulatory requirements are addressed.
• Provide management, training, and support for UMCIRB members on the Biomedical Institutional Review Board (IRB).
• Function as the primary support for the Biomedical IRB Board by pre-reviewing IRB submissions for accuracy and completeness, appropriately addressing regulatory and ethical issues, and attending Biomedical IRB meetings at which the position will advise the members as requested, take notes on IRB deliberations and convey those deliberations to the investigator within the ePIRATE system.
• Responsible for drafting Biomedical IRB meeting minutes, per federal regulations, for review and approval by the convened IRB.
• Responsible for screening all clinical trial submissions for compliance with regulations governing the use of humans in research.
• Work with the Director and other UMCIRB staff to support functions of the Social/Behavioral IRB Board. Recruit appropriate and engaged ECU faculty/staff as well as non-ECU affiliated individuals of the community to become UMCIRB members.
• Develop education, training and resources for a wide variety of investigators and other customers based on hot topics, new federal guidance or local policies/rules.

Human Research Protections Program Support - 30%:

• Provide human subject research guidance and education to UMCIRB staff and committee members, and faculty/staff/student investigators (individually or departmental).
• Interact and communicate with other local institutional and regulatory officials regarding human research.
• Assist Director by researching, proposing and developing necessary and appropriate policy/procedure changes within the UMCIRB according to local, state and federal policy changes and guidance.
• Consult with and query federal regulatory agents (OHRP, FDA, DOD, etc.) as needed for guidance to ensure UMCIRB's satisfaction of regulatory requirements.
• Draft and maintain Individual Investigator Agreements with individual research team members.
• Draft, review and execute IRB Authorization Agreements with collaborating institutions and external IRBs.
• Maintain and update UMCIRB website.
• Conduct post IRB-approval monitoring including but not limited to: routine and for-cause monitoring of human research, reporting findings from monitoring to appropriate parties, development of educational and training programs and development and dissemination of materials such as study tools, templates, and guidance for use by investigators and key study personnel.

Research HIPAA Compliance - 25%:

• Serve as the primary IRB reliance manager for East Carolina University.
• Evaluate human research studies to determine appropriate IRB review models, including reliance or local review.
• Provide expert guidance on NIH and other sponsor single IRB requirements.
• Coordinate, negotiate, and manage IRB Authorization Agreements and related reliance documentation.
• Oversee institutional responsibilities when ECU relies on or serves as the reviewing IRB.
• Maintain accurate reliance records and documentation in the electronic IRB system.
• Develop tools, guidance, and training materials related to IRB reliance and sIRB review.
• Monitor regulatory developments and best practices related to reliance and recommend process improvements.

Other - 5%:

• Other Duties as assigned.

Contingent upon availability of funds.

Minimum Education/Experience

Bachelor's degree and one year of experience related to the area of assignment; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

License or Certification Required by Statute or Regulation

None

Preferred Experience, Skills, Training/Education

• Master's Degree
• Degree in clinical research, health-related or biomedical field.
• Experience with electronic data management systems.
• Experience with regulatory documents and interpretation of said documents and summarizing information to convey to relevant parties.
• Experience in the development of standard operating practices and educational workshops & training.
• Experience with single IRB review and IRB reliance agreements.
• Experience working in a university and/or health care setting.
• Certification as an IRB Professional (CIP); Clinical Research Professional (CCRP); or Clinical Research Associate (CRA) or eligibility to apply for certification.
• Knowledge of biomedical research, social, behavioral or education research, data security and confidentiality, multi-site and collaborative research.
• General knowledge of Good Clinical Practice (GCP), ICH, FDA, OHRP, federal regulations related to human subjects' research as well as the ethical principles in the Belmont Report
• Ability to work with diplomacy and tact while working with high level faculty members and staff.
• Strong verbal and written communication skills and good customer service skills.
• Ability to multi-task and prioritize work assignments.

Special Instructions to Applicant

East Carolina University requires applicants to submit a candidate profile online in order to be considered for the position. Candidates must also submit a cover letter, resume, and a list of three references, including contact information, online.

At the time of employment two to three original letters of reference, official transcripts, a criminal background check, and proper documentation of identity and employability are required. Please be aware that if selected as a candidate of choice, an automatic e-mail will be sent to the individuals entered by the applicant in the References section in the PeopleAdmin applicant tracking system. Letters of reference submitted via the PeopleAdmin applicant tracking system will be verified and considered towards meeting this requirement.

Applicants must be currently authorized to work in the United States on a full-time basis.

Additional Instructions to Applicant

• In order to be considered for this position, applicants must complete a candidate profile online via the PeopleAdmin system and submit any requested documents. Additionally, applicants that possess the preferred education and experience must also possess the minimum education/experience, if applicable.
• Unless otherwise identified in the applicable job posting and consistent with University policy, the University will principally employ individuals who reside in the State of North Carolina to the greatest extent practicable. As such, most positions at East Carolina University require employees to live and work in North Carolina (or live within a reasonable daily commuting distance from their duty station) after hire. Candidates should be prepared to relocate within a reasonable, agreed-upon time after an offer of employment has been made and accepted to meet this requirement.

Job Open Date 06/30/2026 Open Until Filled No Job Close Date - Positions will be posted until 11:59 p.m. EST on this date. If no closing date is indicated, the position may close at any time after the initial screening date. 07/28/2026 Initial Screening Begins Rank Level Quick Link for Direct Access to Posting https://ecu.peopleadmin.com/postings/94782 Nondiscrimination Statement

East Carolina University is committed to workforce success and cultivating a culture of care for our employees. ECU prohibits unlawful discrimination and harassment based on race/ethnicity, color, genetic information, national origin, religion, sex, sexual orientation, gender identity, age, disability, political affiliation, and veteran status. All qualified applicants will receive consideration for employment without regard to their protected veteran status or disability.

Individuals requesting accommodation under the Americans with Disabilities Act Amendments Act (ADAAA) should contact the ADA Coordinator at (252) 737-1018 (Voice/TTY) or ADA-Coordinator@ecu.edu.

Eligibility for Employment

Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. ECU participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States.

Department for People Operations, Success, and Opportunity

If you experience any problems accessing the system or have questions about the application process, please contact the Department for People Operations, Success, and Opportunity at (252) 328-9847 or toll free at 1-866-489-1740 or send an email to employment@ecu.edu. Our office is available to provide assistance Monday-Friday from 8:00-5:00 EST.

Supplemental Questions

Required fields are indicated with an asterisk (*).

• • Will you now or in the future require visa sponsorship for employment?

• Yes

• No

• • Please indicate where you learned about this job vacancy.

• LinkedIn

• Chronicle of Higher Education

• CareerBuilder

• Greenville Daily Reflector

• Raleigh News & Observer

• HigherEdJobs.com

• InsideHigherEd.com

• Monster.com

• Indeed

• ECU Website

• Other

Documents Needed To Apply

Required Documents

• Curriculum Vitae/Resume
• Cover Letter
• List of References

Optional Documents