IRB Analyst or IRB Senior Analyst

University of Virginia•Charlottesville, VA

3d•$65,000 - $95,000•Remote

About The Position

The University of Virginia seeks an IRB Analyst or IRB Senior Analyst. The level will be determined by qualifications. This position is available within the Institutional Review Board Health Sciences Research (IRB-HSR) Human Research Projection Program (HRPP) with the Vice President for Research (VPR) Office. This position will focus on ensuring safety, security, and adherence to federal and state laws and regulations as they apply to human subjects research. These roles involve protecting human subjects involved in clinical research, by enforcing laws, such as those in the Common Rule 45CFR46, and ensuring compliance with legal and regulatory requirements, such as those of the Food and Drug Administration (FDA). This role is also responsible for ensuring that the university adheres to all applicable laws, regulations, and internal policies as they relate to human subjects research. This role will monitor university human subjects research operations, and develop compliance programs & provide training to reduce legal and regulatory risks as necessary.

Requirements

Bachelor's degree. 4 years of relevant experience may be considered in lieu of a degree.
At least two years of relevant experience (for IRB Analyst).
Four years of relevant experience (for IRB Senior Analyst).

Nice To Haves

Current Certified IRB Professional (CIP) or certification obtained within 3 months

Responsibilities

Provide advice/education to investigators regarding federal and state regulations, ethical principles on the protection of human subjects and assistance with developing and processing submissions to the IRB-HSR.
Perform administrative review of complex biomedical research protocols.
Act as the liaison between institutions and external IRBs, managing the administrative and regulatory processes for multi-site research when UVA serves as the IRB of Record.
Has the responsibility of moving reliance modification submissions through workflow in a timely manner, ensuring that submissions are review-ready prior to reliance, conducting reliance reviews, and generating correspondence after the reliance review process is complete.
Act as the back-up liaison between institutions and external IRBs, managing the administrative and regulatory processes for multi-site research when UVA relies on an external IRB.
When appropriate, serve as an IRB member and conduct reviews and approvals of expedited submissions.
Ensure sensitive and confidential issues are concisely and properly communicated, negotiated, resolved and documented.
Point out deficiencies in policies, procedures, as well as guide and assist in drafting revisions.
Obtain and maintain CIP certification when qualified.
Conduct accurate data entry and maintenance of all protocol review activities.
Prepare board meeting materials, and coordinate the dissemination of submissions to board members.
Communicate professionally and efficiently with all levels of the organization.
Assist with migrating to a new electronic system (Huron) to allow for a smooth transition and better management of our changing workflows.
Attend team meetings and other seminars/workshops as required.