Management of all IRB studies submitted with Sentara Healthcare as the primary site.  Assists in the management of collaborative studies involving Sentara as a sub-site.  Ensures such studies reviewed by EVMS IRBs and the IRB office meet all relevant federal, state and institutional regulations, guidelines and expectations.  This position has a direct impact on the compliance of both institutions regarding the use of humans in research.  The position will be housed in the EVMS IRB office and will be reporting to the Director of the Human Subjects’ Protections Program.

Serves as primary contact to assist Sentara investigators as well as external investigators requesting access to Sentara records and using the EVMS IRB.  Assists investigators and research staff in preparing submissions to ensure that both Sentara and EVMS policies are addressed in submissions. This includes screening of the submissions for completeness and accuracy; and, contacting and assisting individuals to bring that process to fruition. The IRB Administrator is responsible for ensuring that such 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 or other submissions for existing approved human subjects research studies.

Ensure studies that involve Sentara are submitted properly through Sentara’s internal process for review and approval.  Notifying PI of those reviews and outcomes.  Assisting or providing guidance on any changes or additional information requested by Sentara.

Runs various reports specific to Sentara studies, whether the studies are the primary site or other collaborative sites; including the investigators; types of studies; the approval date and renewal dates; and notifications of closures or terminations, etc.  Reports may be frequent, such as monthly, and include metrics specific to Sentara and EVMS times for reviews.  Report information and timing may vary depending on the requests and will require learning the IRB software, its available standard reports as well as custom reporting options.

Accurately record detailed discussion and/or changes at the IRB meetings so documents may be edited post-meeting and returned to with a potential IRB approval. 

Revise certain study documents after an IRB meeting with the requested changes and present those to the site for acceptance or revision.  Changes must be precise to ensure compliance with regulations can be demonstrated; must compose clear and concise revisions to ensure that all the concerns and technical questions of the Board are quickly and intelligibly addressed in the final version and/or communicated to each researcher in a reasonable time post-meeting

Develop Sentara template forms and template language for various types of studies and ensure the inclusion in IRB documents.

Assist with IRB QA reviews/audits of Sentara studies and/or investigators using the EVMS IRBs.

Assist with any Reliance Agreements needed for studies presented to the EVMS IRBs.

Works collaboratively with Sentara Healthcare leaders in research and the EVMS Director and Assistant Director of the Human Subjects’ Protections Program to maintain compliance with state and federal mandates and to maintain updated Sentara policies and procedures for IRB submissions.

Performs other duties as assigned which may be related to any IRB activity in the EVMS IRB office.

Bachelor’s degree preferred but significant experience (at least eight years) with an academic IRB may be substituted for degree. Previous experience in clinical research administration and/or IRB experience is preferred. CIP certification preferred. Must be able to communicate effectively and professionally, both orally and in writing, with diverse groups including school administrators,  EVMS IRB members, research investigators, residents, students, and contacts at our partner, Sentara Healthcare. Experience in Microsoft Office products such a Word, Excel, Powerpoint, and File Explorer.

Other Skills

• Familiarity with state and federal regulations and institutional guidelines in order to provide appropriate guidance to investigators, staff and IRB members.
• 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.

• Exercise independent judgment to coordinate, organize, prioritize, and complete work assignments in a timely and efficient manner.