POSITION RESPONSIBILITIES

• Independently understands and applies the Federal Regulations for human research to all project applications (pre-review, re-review, clarifying issues, post meeting, non-committee review) to ensure adherence to regulatory and ethical standards.
• Independently conducts regulatory and administrative reviews of Exempt, Expedited and Full Board submissions
• Evaluate investigator responses/requests
• Provides engagement determinations.
• Serves as an IRB member.
• Independently oversees Board meeting, including but not limited to: making assignments to staff and Board members, obtaining & maintaining quorum for the meeting and providing regulatory guidance at the meeting and writing minutes.
• Serve as the administrator for one of the following ancillary committees: Global Research, Stem Cell Research, or Fetal Tissue research. Ancillary committees function as an added level of review, according to regulatory and/or institutional requirements, and are conducted on an as needed basis. This will involve acting as a liaison between the IRB, the research community, the Office of General Counsel or other entities as required; ensuring all additional requirements are fulfilled, before releasing approval. Supporting and educating and training board members in the review and approval of research subject to ancillary committee reviews. The administrator will also be involved in the oversight of the Committee functions, including writing and maintaining minutes and relevant policies.
• Participate in IRB Analyst candidate interviews and provide onboarding training for new Analysts.
• Serves as ongoing mentor and educator for IRB Analysts, assisting managers and directors with day-to-day oversight of the department.
• Works closely with managers and directors within OHRA to set and implement priorities and to update policies and procedures.
• Assists OHRA leadership with internal QI monitoring and compliance.
• Participates in regional and national conferences and educational events.
• Provides regulatory and ethical consults for investigators and research personnel on human subjects research related issues.
• Gives presentations to IRB staff, Board members and the research community.
• Other duties as assigned.

QUALIFICATIONS

• Bachelor's Degree and 3 or more years of direct IRB experience required. Equivalent combination of experience and education will be considered
• Knowledge of applicable federal and state regulations (including 45 CFR 46, 21 CFR 50, 56, 312, 812) required.
• CIP required within one year; CCRP certification a plus
• Must be able to work independently with minimal supervision.
• Excellent written and oral communications skills.
• Excellent customer service skills.
• Excellent ability to think creatively and demonstrate superb analytical reasoning ability.
• Strong familiarity with Microsoft Office (Word, Windows, Excel).
• Ability to adapt to custom web-based software.
• Ability to develop and lead educational programs, and to train groups and individuals.
• Ability to exercise sound judgment, integrity, and initiative in implementing effective solutions.

Additional Information

Minimum Salary Range

Maximum Salary Range