Assist in the management of all EVMS IRBs and the IRB office so as to meet all relevant federal, state and institutional regulations, guidelines and expectations. This position has a direct impact on the compliance of the institution regarding the use of humans in research.
Familiarity with state and federal regulations and institutional guidelines in order to provide appropriate guidance to investigators, staff and IRB members. Works independently to ensure that all records and documentation related to IRB activity are complete and accurate.
Receive incoming protocols for the IRB meetings. This includes screening of the submissions for completeness and accuracy and potentially contacting individuals to bring that process to fruition. The IRB Administrator is directly responsible for ensuring that research submissions are complete so that each submission can be adequately reviewed by the Board.
Provides guidance to investigators and their research coordinators during the submission and approval process of the IRBs. Answers questions, addresses issues and reviews modifications of human subjects research studies.
Creates highly detailed minutes that describe the activities undertaken at the IRB meetings so compliance with regulations can be demonstrated; composes clear, concise and detailed correspondence to ensure that all the concerns and technical questions of the Board are quickly and intelligibly communicated to each researcher.
Works collaboratively with the IRB Manager and Associate Dean for Research Subjects’ Protections to maintain compliance with state and federal mandates and to maintain updated EVMS IRB Standard Operating Procedures.
Performs other duties as assigned.
Bachelor’s degree required. One year previous experience in clinical research administration and/or IRB experience required.
Must have critical thinking skills to understand state and federal regulations and institutional policies and procedures and to interpret and apply that knowledge to a variety of academic and scientific activities.
Ability to read research protocols so that appropriate human subjects’ protections can be considered and applied to the materials.
Information technology skills to work in a web-based database application. Must be able to understand the relationship between data entries and future outcomes. Must have accurate data entry skills and ability to logically complete entries.
Ability to instruct investigators and their staff members on the process and procedures for IRB approval of human subjects research.