IRB Analyst ll

Job Description

Summary:

The Office of Human Research ( OHR ) supports The George Washington University research community in the conduct of innovative and ethical research by providing guidance, education, and oversight for the protection of human subjects. The Institutional Review Board ( IRB ) Analyst II reports to the OHR Director and manages the review of human research study applications at all levels and stages of review and approval to ensure timely and accurate approval consistent with applicable regulations and institutional policy.

• Independently conducts specialized risk, compliance and protocol analysis of research applications in order to determine the nature and level of risk. Manages the research review process throughout the life cycle of a research proposal, which includes:
  • Managing the convened IRB meeting process, including: serving as the primary consultant to the IRB (“Board”) and to the investigators; making solution-oriented recommendations for changes to the protocol and other study documents to revise, minimize, or mitigate risk; and analyzing and documenting Board discussions and the changes required for IRB approval.
  • Continued monitoring and management of research applications after the initial IRB approval (“post-approval”) by counseling investigators about proposed changes in study parameters, assisting in the development and implementation of solutions to resolve issues that affect research participants’ rights/welfare, and to promote compliance with federal guidelines and University policies and procedures.
• Manages the IRB Reliance process/single IRB (sIRB) arrangements. This includes the review of Reliance Agreements and communication with internal and external entities to facilitate and execute these agreements. Promotes compliance with applicable regulations and institutional policy both when GW is the Reviewing IRB for multi-site research and when GW will Rely on external IRBs. Serves as a liaison with external IRBs, as necessary.
• Provides guidance to research investigators on the IRB application and approval process and requirements; and serves as a liaison to investigators, research coordinators, and other individuals across a variety of GW academic and medical center departments to analyze, interpret and resolve issues that impact the rights and welfare of human research participants.
• Collaborates with OHR leadership on special projects, as needed, in support of the GW Human Research Protection Program ( HRPP ).
• Performs other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

Qualified candidates will hold a Bachelor’s degree in an appropriate area of specialization plus 2 years of relevant professional experience, or, a Master’s degree or higher in a relevant area of study. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience.

• Previous human subject research or regulatory analysis experience is strongly preferred. Preference for applicants who hold the Certified IRB Professional ( CIP ) credential and who have experience working in a reliance program.
• Possesses excellent interpersonal and communication skills and demonstrated ability to work effectively with team members and researchers.
• Demonstrates critical thinking and flexibility in decision-making in the application of policies and regulations.
• Able to work effectively in an environment that requires constant evaluation and shifting of priorities to respond to the needs of the University research community.

GW offers a…