Senior IRB Analyst

Senior IRB Analyst East Carolina University - 4.3 Greenville, NC Job Details 4 hours ago Qualifications Customer communication Full Job Description 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 . 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 . Our office is available to provide assistance Monday-Friday from 8:00-5:00 EST.