Senior Research Analyst

East Carolina University

$54,249 - $75,000

United States, North Carolina, Greenville

May 05, 2025

Posting Details

Position Information

Job Title	Senior Research Analyst
Position Number	002374
Vacancy Open to	All Candidates
Department	AAH REDE Institutional Review Board
Department Homepage	https://rede.ecu.edu/umcirb/
Advertising Department	OFFICE OF RESEARCH
Division	Academic Affairs
Classification Title	Specialist
Working Title	Senior Research 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.	$54,249 - $75,000
Position Location (City)	Greenville
Position Type	Non-Faculty
Job Category	Non-Faculty Professional
Organizational Unit Overview	Under delegated authority from the Chancellor of East Carolina University, the Assistant Vice Chancellor for Research Administration and Compliance is accountable to the Federal government and other regulatory agencies for protection of humans who are the subject of any research by investigators within East Carolina University. The University and Medical Center Institutional Review Board ( UMCIRB) is the entity which oversees all human subject research, under delegated authority from the Assistant Vice Chancellor. The UMCIRB reviews human research plans from all across ECU's campus, the ECU Health system and has affiliations with other entities to conduct their reviews. Such research includes clinical or patient-related research, including clinical trials. It also includes surveys and other types of research using human subjects, such as research conducted with children by the College of Education; psychological research involving adults and children; and all other types of human research throughout the university. The UMCIRB's mission is critical to the university and local investigators because it: (1) protects the rights and interests of human subjects involved in research; (2) protects the university and researchers by ensuring its review function is in compliance with regulatory requirements; and (3) advises investigators in navigating the regulatory and compliance requirements that direct their research plans.
Job Duties	The primary purpose of the Senior Research Analyst for the Institutional Review Board is to support the overall administration of the human research review and approval process, providing high-level support and guidance to investigators and other stakeholders, and streamlining Institutional Review Board ( IRB) processes. Through these activities, the Senior Research Analyst helps ensure that the University's human research activities are in compliance with institutional SOPs and international, federal, state, and local rules and regulations, and the ethical principles regarding the involvement of humans in research to protect their safety, rights, and welfare. The Senior Research 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 Research 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. This position performs the following duties: 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 - 40% 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 - 15% Provide guidance and answer questions/concerns from research personnel regarding creation, collection, disclosure or use of patients Protected Health Information (PHI) for covered entities/healthcare components at ECU. Assist in resolving research issues involving the use of humans in research or use, disclosure and storage of PHI and review study submissions utilizing PHI to ensure compliance with the Privacy and Security Rules. Serve as a liaison with other regulatory units within ECU as it pertains to clinical trials and PHI. Provide HIPAA Privacy Board oversight. Educate UMCIRB committee members (also the Privacy Board for ECU) regarding their role related to HIPAA and human research; educate UMCIRB staff about the related procedures they need to support within ePIRATE to document Privacy Board requirements; provide guidance to investigators and other stakeholders to resolve issues related to HIPAA and research; maintain current knowledge of HIPAA security and privacy changes related to how these may affect IRB review or processes. Other - 5% Other Duties as assigned. This position may be eligible for Flexible Work Arrangements ( FWA) under the East Carolina University ( ECU) FWA Policy. Contingent upon availability of funds.
Minimum Education/Experience	Master's Degree, or Bachelor's degree and three years of experience in a related discipline. 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 Protected Health Information and information technology security. Experience working in a university and/or health care setting.
License or Certification Required by Statute or Regulation	None
Preferred Experience, Skills, Training/Education	Degree in clinical research, health-related or biomedical field. 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. Ability to work with people with broad backgrounds. 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. 2-3 original letters of reference are required for employment. 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.
Job Open Date	05/05/2025
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.	05/27/2025
Initial Screening Begins
Rank Level
Quick Link for Direct Access to Posting	https://ecu.peopleadmin.com/postings/85982
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.