IRB Specialist

IRB Specialist

IRB Specialist

This is a 100% remote position.

Department: Department: Office of Research, Innovation & Economic Development, Division of Research Integrity &Assurance

Job Summary/Essential Job Functions

This position supports the Human Research Protection Program (HRPP) and serves as a subject matter expert in human research subjects protections and related compliance activities that facilitate university compliance with federal regulations, state and local laws, guidelines and institutional requirements.

Duties and Responsibilities

Protocol Review:

• Conduct high quality and thorough reviews of Institutional Review Board (IRB) protocol submissions for research involving human subjects under the purview of the IRB ensuring that protocol submissions adhere to ethical standards and compliance with federal regulations and guidelines, state and local laws as well as institutional policies.
• Ensure timely completion of reviews in accordance with established standards for turnaround on protocols submitted by investigators.
• Provide preliminary reviews of protocols (pre-submission) in order to assess completeness, compliance and coherence of materials.

Subject Matter Expert:

• Maintain knowledge and expertise in federal regulations and guidelines, state and local laws as well as institutional policies related to human subjects research protections and related compliance issues and advise IRB members, investigative committees and other university units/personnel related to such matters.
• Investigate questions and advise investigators regarding regulatory, institutional and IRB requirements. Advise and assist investigators on matters relating protocol development and maintenance over the lifecycle of the research and other human research subjects requirements and compliance matters.
• Provide ongoing service and education to the university community on human research subjects protection related issues and emerging requirements.
• Assist in conducting or otherwise provide expertise for investigations of non-compliance, complaints, etc.
• Assist in the development of training materials and communications across all relevant media channels.

Administrative Support:

• Coordinate IRB meetings including the preparation of Board meeting materials. Take detailed and accurate meeting minutes chronicling ethical, regulatory and scientific/scholarly issues considered by the Board and accurately document determinations.
• Draft correspondence to investigators related to IRB determinations, etc.
• Assist with quality improvement activities including obtaining and maintaining AAHRPP accreditation.
• Assist with the maintenance of IRB records including electronic submission and review system support (iMedRIS).

Required knowledge, skills, and abilities:

• Ability to maintain the highest ethical standards in the field of human subjects research
• Advanced knowledge of federal regulations, state and local laws, plus institutional requirements related to human research subjects protection
• Ability to interpret, apply and communicate federal and institutional guidelines, regulations, statutes, and institutional policies
• Ability to work collaboratively with a diverse community at all levels
• Must have excellent interpersonal skills and ability to work individually and in collaboration with others at various levels
• Ability to maintain strong customer-service
• Must have strong organizational, analytical, and problem solving skills with a high attention to detail
• Ability to identify, prioritize, and pro-actively manage high volume workload, meet deadlines, and support multiple individuals simultaneously
• Must have strong verbal and written communication skills with ability to communicate and work effectively with individuals from different disciplines and backgrounds

Preferred knowledge, skills, and abilities

• Experience in research compliance, research administration, or conducting research in higher education
• Certified IRB Professional (CIP) is preferred. If the candidate is not CIP certified, the expectation would be to become certified within three years beginning in this position.
• Experience with computerized databases
• Experience with and thorough knowledge of iMedRIS
• Experience with biomedical, behavioral and/or social sciences research

Required level/type of experience and/or years of experience

• Minimum of 4 years relevant experience with bachelor's degree or 2 years with advanced degree is required. The experience shall be a combination of progressively responsible research administrative and IRB experience.

Preferred level/type of experience and/or years of experience

• Experience in research compliance, research administration, or conducting research in higher education
• Certified IRB Professional (CIP) is preferred. If the candidate is not CIP certified, the expectation would be to become certified within three years beginning in this position.
• Experience with computerized databases
• Experience with and thorough knowledge of iMedRIS
• Experience with biomedical, behavioral and/or social sciences research

Additional Information

Please attach the following electronic documents to the application: Cover letter, resume, and the names, addresses (postal and electronic), and telephone numbers of at least three references.

Websites

https://research.utk.edu/oried/

https://research.utk.edu/oried/research-integrity-and-assurance/