The Institutional Review Board (IRB) Administrator plays a critical role in providing accurate guidance and regulatory support to Cone Health researchers (faculty, staff, residents, fellows and students) engaged in human subjects research. The IRB Administrator serves as the primary regulatory resource for all researchers and staff at Cone Health. The IRB Administrator is also responsible for managing post-approval monitoring of IRB-approved research and assists with coordinating the Conflict of Interest Disclosure process for researchers, as required by institutional policies.

Primary Duties and Responsibilities

• Provides day-to-day oversight and support of the Cone Health IRB regulatory processes ensuring human subject research conducted at Cone Health complies with all applicable regulations.
• Manages and directs initial and continuing review of research, reporting of unanticipated problems, and serious or continued non-compliance.
• Develops and participate in training and educational activities on human research protections that are presented to researchers and administrators.
• Plans, organizes, and conducts post-approval audits of IRB-approved research to ensure compliance with all relevant laws, regulations, policies and guidelines, to protect human subjects, researchers, and the organization, to assess clinical trial performance, and to discourage scientific misconduct in human subject research.
• Assist the Associate Director of Clinical Research in the design and development of internal clinical research auditing programs;
• Maintain active knowledge of evolving laws, regulations, policies, and ethical norms that are applicable to human research activities through continuous professional development.

Job Requirements

• Bachelor's Degree in a scientific or related field
• 4 years experience in research processes and procedures
• Minimum 2 years IRB or HRPP experience (research experience within an Academic Medical Center, higher education, or related field may be considered in lieu of IRB or HRPP experience depending on prior job functions and responsibilities)
• Knowledge and understanding of federal regulations governing IRBs, including 21 CFR 50 and 56, and 45 CFR 46
• Knowledge or experience in ethics and/or health, law, healthcare administration, research process and health care settings including regulatory aspects that involve human research subjects and Institutional Review Boards

About Cone Health

Cone Health is a not-for-profit health care network in central North Carolina serving people in Alamance, Forsyth, Guilford, Randolph, Rockingham and surrounding counties. Our brand promise – We Are Right Here With You – is shared by our more than 13,000 employees, 1,800 physician partners and 1,000 volunteers. As one of the region’s largest and most comprehensive health networks, Cone Health has more than 100 locations, including five hospitals, five ambulatory care centers, three outpatient surgery centers, six urgent care centers, two retirement communities and more than 120 physician practices. These include primary and specialty care through Cone Health Medical Group and Triad HealthCare Network.

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