IRB Review Specialist

ETSU•Johnson City, TN

About The Position

The Human Research Protection Program (HRPP) is responsible for oversight and management of ETSU’s Institutional Review Boards (IRBs) and ensures compliance with applicable policies, accreditation standards, and external regulations for research involving human participants. We help to facilitate human subjects research and make sure it is done safely, ethically, and legally. We take pride in being service-oriented and flexible. The IRB Review Specialist provides analytical, technical, and professional support to the ETSU IRB and research community. The IRB Review Specialist conducts in-depth reviews of research protocols, provides regulatory guidance, and ensures adherence to ethical standards. This role involves interpreting complex regulations and policies to assist the IRB, researchers, and stakeholders in maintaining research quality and compliance. Additionally, the position contributes to the development of IRB staff, members, and HRPP policies and procedures.

Requirements

Bachelor's degree in relevant field of study and 2 years of professional experience; or equivalent combination of experience and education
Solid computer skills and strong competency in Microsoft Office products
Effective organizational and analytical skills- must be highly organized, demonstrating strong attention to detail and accuracy
Strong written and oral communication skills to be able to work effectively with a highly diverse group of people
Comfort with making judgment calls in ambiguous situations
Knowledge of federal regulations, state and local laws, and institutional requirements related to the conduct of research
Ability to identify, prioritize, and proactively manage high volume workload, meet deadlines, and support multiple projects and stakeholders simultaneously
Must have strong verbal and written communication skills with ability to communicate and work effectively with individuals from different disciplines and backgrounds
Ability to obtain relevant information and identifies key issues and relationships relevant to resolve complex issues or in support of achieving a long-range goal or vision
Strong decision-making skills and demonstrated ability to assess multiple issues analytically in order to apply knowledge to variety of complex situations and research protocols
Strong attention to detail and excellent record-keeping skills with the ability to discern crucial information needed to demonstrate compliance

Nice To Haves

Professional experience in academic research, research compliance, or IRB administration setting
Certified IRB Professional (CIP) credential or relevant certification
Familiarity with ethical principles (Belmont Report) and federal regulations governing human subjects research (e.g., Common Rule, FDA, HIPAA)
Experience with IRB management systems or electronic research administration software
Experience working with an accreditation body and supporting activities necessary to achieve and maintain accreditation
Familiarity with electronic research administration software

Responsibilities

Conducts in-depth reviews of research protocols.
Provides regulatory guidance.
Ensures adherence to ethical standards.
Interprets complex regulations and policies to assist the IRB, researchers, and stakeholders in maintaining research quality and compliance.
Contributes to the development of IRB staff, members, and HRPP policies and procedures.