Senior Research Analyst

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 ECUs 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 UMCIRBs 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 Universitys 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 - 50%

• 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 Social/Behavioral Institutional Review Board (IRB).
• Function as the primary support for the Social/Behavioral IRB Board by pre-reviewing IRB submissions for accuracy and completeness, appropriately addressing regulatory and ethical issues, and attending Social/Behavioral 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 Social/Behavioral 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 - 45%

• 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 UMCIRBs 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.

Other - 5%

• Other duties as assigned.

This position may be eligible for Flexible Work Arrangements (FWA) under the East Carolina University (ECU) FWA Policy.

Minimum Education/Experience:

• Masters Degree, or Bachelors 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 working in a university and/or research setting.

Preferred Experience, Skills, Training/Education:

• Degree in a social/behavioral focused discipline such as (psychology, education, sociology, health education, public health, anthropology).
• Experience working in social/behavioral research (psychology, education, sociology, health education, public health, anthropology).
• 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.

To apply, visit https://ecu.peopleadmin.com/postings/87116