The George Mason University Research Support Office invites applications for an IRB (Institutional Review Board) Compliance Specialist. George Mason University has a strong institutional commitment to the achievement of excellence and diversity among it's staff, and strongly encourages candidates to apply who will enrich Mason's academic and culturally inclusive environment.
Performs analysis of protocols to review for completeness and compliance with regulations and IRB policies, sending the protocol to a board member for expedited review, or recommending that it be reviewed by the entire board;
Determines the most expeditious processing mechanism allowed for an application based on an understanding of the proposed research and an interpretation of appropriate guidelines;
Determines whether the protocol constitutes human subject research and assigns the appropriate category under federal guidelines;
Makes exemption determinations;
Attends monthly IRB meetings and provides technical support and guidance on regulatory matters;
Writes highly detailed meeting minutes to outline the issues analyzed by the committee and accurately documents the final determinations of the IRB;
Composes clear, concise and detailed correspondence to investigators to ensure that the concerns, rationale and technical questions of the IRB are quickly and intelligibly communicated to the researchers;
Conducts an evaluation of the investigator's response to identify potential issues for IRB reviewers;
Determines when IRB requirements for approval have been met and issues approval documents;
Maintains accurate electronic IRB files;
Assists in creating meeting agendas and meeting material preparation;
Meets with investigators and research staff to advise them on federal regulations and IRB submission requirements, and assists them as needed in the preparation of submission forms.
Experience working in a research environment and familiarity with the IRB;
Excellent writing skills are needed to generate clear, precise, detailed and grammatically correct technical letters, memos and reports;
Exceptional analytical ability is necessary in order to apply knowledge of federal regulations and institutional policy to research proposals;
Superior organizational skills and attention to detail are required in order to effectively and efficiently manage multiple priorities and a high-volume workload;
Strong interpersonal and communication skills with a capacity to work well with multiple constituencies of various educational and social backgrounds;
Proficiency in the use of multimedia hardware and software applications including the use of MS Windows, database, spreadsheet and word processing, and familiar with online protocol submission systems;
Must have the ability to make accurate and appropriate independent judgments, but able to accept direct supervision and know when to refer issues to supervisor.
Bachelor's degree or combination of education and experience;
Experience in reviewing IRB applications and applying DHHS and FDA regulations;
Current CIP certification or ability to pass CIP certification exam in the first year of employment;
Experience using electronic submission/tracking systems.
Must be a citizen of the United States, a person who is a lawful permanent resident of the United States (a
Internal Number: 48501
About George Mason University
George Mason University is Virginia's largest public university located in the suburbs of Washington, D.C. With strong undergraduate and graduate degree programs in engineering, information technology, public policy, economics, visual and performing arts, life sciences and biotechnology, Mason prepares its alumni to succeed in the workforce and meet the needs of the region and the world.