IRB Compliance Specialist

Department: Office of Research, Innovation, and Economic Impact
Classification: Gen Admin Supv 2/Coord 2
Job Type: Full-Time (1.0 FTE, 40 hrs/wk)
Location: Remote

About The Department

The Office of Research Integrity and Assurance (ORIA) fosters and promotes state-of-the-art research and scholarship at Mason, providing resources that promote ethical and responsible conduct of research. The office provides services that ensure Mason's research and scholarship community is knowledgeable about and complies with federal and other relevant regulations that pertain to research and research integrity. ORIA also identifies compliance risks, communicates those risks to the Mason community, and monitors and investigates instances of noncompliance.

About The Position

The IRB Specialist supports Mason's commitment to ethical conduct of human subjects research by providing essential operational, administrative, and compliance support for the Institutional Review Board Program. This position helps ensure that human subjects research is reviewed, documented, and managed in accordance with applicable federal and state regulations, institutional policies, and ethical standards. The position contributes to the university by supporting faculty, students, and staff throughout the IRB submission and review process, maintaining accurate records, facilitating communication, and helping ensure consistent and timely processing of protocols. By strengthening the day-to-day operations of the IRB program, the IRB Specialist supports responsible research practices, improves the researcher experience, protects research participants, and reduces institutional compliance risk. This position is primarily remote with occasional travel to campus required.

Responsibilities

• Evaluates and manages incoming applications to ensure that all information is provided.
• Completes all necessary checklists and worksheets.
• Completes and sends reminder/follow-up letters and email.
• Performs initial, amendment, and continuing reviews of research protocols to include those subject to FDA and DHHS regulations.
• Reviews applications for completeness and to determine whether or not each protocol meets the definition of human subjects research.
• Evaluates risk to subjects and others.
• Determines appropriate level of review for each protocol.
• Reviews each protocol to ensure that GMU and federal regulations are met and that the researchers have addressed all of the IRB's concerns before final approval.
• Obtains adequate expertise for the review of research through consultation where necessary.
• Instructs and counsels investigators and research support staff.
• Works one-on-one with investigators and students to explain regulations and procedures.
• Assists with educational IRB presentations.
• Ensures that investigators and their staff complete required CITI training.
• Maintains complete, accurate, and error-free records including IRB minutes.
• May be required to perform other duties as assigned, including assisting the agency or state government generally in the event of an emergency declaration by the Governor.

Requirements

• Bachelor’s degree in a related field or an equivalent combination of education and experience.
• Active Certified IRB Professional (CIP) or ability to obtain certification within two years of employment.
• Experience working in a research environment and familiarity with the IRB.
• Excellent writing skills to generate clear, precise, detailed, and grammatically correct technical letters, memos, and reports.
• Superior organizational skills and attention to accuracy 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.
• Exceptional analytical ability to apply knowledge of federal regulations and institutional policy to research proposals.
• Ability to work effectively under pressure and to meet deadlines.
• Ability to identify when to refer issues to a Senior IRB Compliance Specialist and/or supervisor, make accurate and appropriate independent judgments, and accept direct supervision.
• Ability to effectively advise investigators and research staff on federal regulations and IRB submission requirements, and assist them as needed in preparation of submission forms.
• Proficient in the use of multimedia hardware and software applications, including Windows, RAMP, spreadsheet, and word processing.

Preferred Qualifications

• Experience in a human research-related administrative or clinical setting, ideally in a higher education environment.
• Experience using electronic submission systems.
• Working knowledge of federal regulations governing human subjects research.
• Demonstrated skill in advising investigators and research staff on federal regulations and IRB submission requirements, and assisting them as needed in preparation of submission forms.