Associate Director, Human Subjects Research Protection Program
George Mason University
Location: Fairfax, Virginia
Type: Full Time
Required Education: Masters
Internal Number: FA88Hz
Associate Director, Human Subjects Research Protection Program
The George Mason University, Office of the Provost seeks a highly motivated, well-qualified person to serve as the Associate Director, Human Subjects Research Protection Program. George Mason University has a strong institutional commitment to the achievement of excellence and diversity among its faculty and staff, and strongly encourages candidates to apply who will enrich Mason’s academic and culturally inclusive environment.
About the Position:
The Associate Director is responsible for the overall leadership and management of Mason’s Human Subjects’ Protection Program, managing essential elements of the university’s research compliance program to facilitate research while ensuring compliance with applicable federal, state and institutional regulations and policies within the professional framework of Responsible Conduct of Research (RCR). The Associate Director will exercise substantial independence, authority and discretion in designing and providing programmatic oversight for Mason’s Human Subjects’ Protection Program. The Associate Director reports directly to the Assistant Vice President, Research Integrity. As a key professional in Mason’s Office of Research, Integrity and Assurance (ORIA), the Associate Director is responsible for ensuring compliance with all reporting requirements to Mason’s Institutional Official as well as to outside federal regulatory agencies. The Associate Director is responsible for managing the operations of the university’s Institutional Review Board (“IRB”) as well as the human subjects protection program staff within ORIA. ORIA nurtures and promotes state-of-the-art research and scholarship at Mason, providing resources that promote the ethical and responsible conduct of research and support the university’s commitment to meet the highest ethical standards in research and scholarship.
Supervising IRB support staff in providing protocol reviews and communication with investigators to ensure an efficient process for compliance reviews and feedback; Performing reviews of complex research protocols, including serving as a designated reviewer, identifying problems and issues in submission applications and contacting the investigator(s) to obtain clarifications; Supervising the review of reliance agreements; Providing guidance and professional support to Mason’s IRB regarding procedural and regulatory requirements of human subjects research; Ensuring appropriate staff support for the Board to ensure that accurate and compliant agendas, minutes, board documents, communications and other records are maintained; Ensuring appropriate office communication through email, telephone calls and the ORIA website; Developing and maintaining policies and procedures in support of Mason’s human subjects program; Designing and providing outreach and training on all aspects of Mason’s research with human subjects, including providing lectures to graduate and undergraduate classes at Mason; Serving as a key resource for investigators who have questions about regulations or appropriate protocols for human subjects research, and working collaboratively with investigators to improve understanding of and compliance with human subjects research requirements; Supervising and providing direction for Mason’s post-approval monitoring program as well as for audits of projects of concern; Working closely with external colleagues to ensure Mason maintains a high-quality IRB program that is appropriately aligned with peer exemplary practices; Overseeing and navigating important and sensitive interactions with key stakeholders across campus, including collaborations concerning ancillary reviews; Preparing and presenting reports and summaries to institutional leadership, IRBs and/or research community as appropriate; Performing other related duties and participate in special projects as assigned.
Master’s degree or an equivalent combination of education and/or experience; Active Certified IRB Professional (CIP); 5-7 years of experience in IRB operations; Excellent communication skills (both verbal and written), excellent attention to detail, strong problem solving and decision-making skills, the ability to make decisions independently, the ability to facilitate complex conversations about integrity and ethics; High degree of personal integrity and ethics; Strong background in research administration, including a broad and nuanced knowledge of compliance regulations and how they relate to university compliance goals; Proven track record supporting a vibrant research compliance program; Experience with and commitment to working in and fostering a diverse faculty, staff and student environment or a commitment to doing so at Mason; Reputation for successfully working with faculty, staff and students to help them achieve their research goals; Experience directly supervising IRB staff, including performance evaluations; Significant experience reviewing clinical trials and FDA regulated research; Extensive working knowledge of applicable federal, state, and local related to human subjects research; Ability to take prioritize tasks, take initiative and simultaneously manage multiple projects with minimal supervision, while meeting assigned deadlines.
Master’s degree in a health care or regulatory related field.
Special Instructions to Applicants: For full consideration, applicants must apply for position number FA88Hz at http://jobs.gmu.edu by September 30, 2021; complete and submit the online application; and upload a cover letter, CV, and a list of three professional references with contact information.
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, sexual orientation, gender identity, national origin, age, disability or veteran status, or any characteristic protected by law.
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