General Administration Supervisor II/Coordinator II
Job Category : Classified Staff
Working hours :
Salary : Commensurate with education and experience.
Web Announcement :
Senior IRB Compliance Specialist
The George Mason University Research Development, Integrity and Assurance (RDIA) office invites applications for a Senior IRB (Institutional Review Board) Compliance Specialist.
Responsibilities: The primary responsibilities of the Senior IRB Compliance Specialist include the following:
- Performing analysis of protocols to review for completeness and compliance with regulations and IRB policies and procedures;
- Determining whether the protocol constitutes human subjects research, assigning the appropriate category under federal guidelines; and
- Either performing the evaluation, sending the protocol to a board member for expedited review, or recommending that it be reviewed by the full board. The Senior IRB Compliance Specialist determines the most expeditious processing mechanism allowed for an application based on an understanding of the proposed research and an interpretation of appropriate guidelines. In addition, the Senior IRB Compliance Specialist 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. The Senior IRB Compliance Specialist also 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 evaluation of investigatorâ€™s response to identify potential issues for IRB reviewers; determines when IRB requirements for approval have been met and issues approval documents. The Senior IRB Specialist maintains accurate electronic IRB files; assists in creating meeting agendas and with 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; and conducts educational IRB classroom presentations as needed.
- Bachelorâ€™s degree or equivalent combination of education and relevant experience;
- Experience reviewing social and behavioral IRB protocols;
- 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 be familiar with online protocol submission systems;
- Must have the ability to make accurate and appropriate independent judgments, but be able to accept direct supervision and know when to refer issues to supervisor; and
- Ability to pass CIP certification exam in first year of employment.
- Experience reviewing biomedical protocols, including FDA covered protocols;
- CIP certification; and
- Experience with IRB reliance agreements/single IRB reviews.
Special Instructions : For full consideration, please complete the online application at https://jobs.gmu.edu/ and attach a cover letter, resume, and list of three professional references with contact information.
MasonAd : Great Careers Begin at Mason!
George Mason University is an innovative, entrepreneurial institution with national distinction in both academics and research. Mason holds a top U.S. News and World Report Up and Coming spot for national universities and is recognized for its global appeal and excellence in higher education.
Mason is currently the largest and most diverse university in Virginia with students and faculty from all 50 states and over 135 countries studying in over 200 degree programs at campuses in Arlington, Fairfax and Prince William, as well as at learning locations across the commonwealth. Rooted in Masons diversity is a campus culture that is both rewarding and exciting, work that is meaningful, and opportunities to both collaborate and create.
If you are interested in joining the Mason family take a look at our current opportunities and catch some Mason spirit at jobs.gmu.edu/!
George Mason University, Where Innovation is Tradition.
Equity Statement : George Mason University is an equal opportunity/affirmative action employer, committed to promoting inclusion and equity in its community. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
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