IRB Operational Manager
4 weeks ago
Join the Commonwealth of Virginia in a dynamic role as an IRB Operational Manager. This position plays a critical role in ensuring the integrity and efficiency of the Institutional Review Board (IRB) process.
Key Responsibilities:- Oversee the daily coordination and facilitation of IRB meetings, including scheduling, agenda preparation, and documentation.
- Ensure thorough review of research protocols, compliance with regulations, and timely decision-making.
- Supervise the expedited review process, including the assignment of protocols to reviewers, monitoring timelines, and ensuring appropriate documentation of reviews.
- Supervise the exempt review process, including the evaluation of research protocols for exemption criteria, documentation of determinations, and communication with researchers.
- Supervise the review and approval process for research involving non-human subjects, ensuring compliance with relevant regulations and institutional policies.
- Facilitate the establishment and management of reliance agreements with external institutions or entities, including negotiation, documentation, and ongoing communication to ensure compliance with regulatory requirements.
- Bachelor's degree in a related field (e.g., healthcare administration, public health, or life sciences).
- Minimum of 3 years experience working as an IRB Operational Manager or equivalent.
- Certified as a Certified IRB Professional (CIP).
- Comprehensive understanding of relevant regulations and guidelines governing human subjects research (e.g., Common Rule, FDA regulations, HIPAA).
- Strong organizational skills with the ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with researchers, IRB members, and external stakeholders.
- Proficiency in Microsoft Office Suite and electronic research administration systems.
- Master's degree in a related field or equivalent training and experience.
- Minimum of 5 years' experience working as an IRB Operational Manager.
- Experience in human participant research and familiarity with institutional policies and procedures regarding human participant research.
The Commonwealth of Virginia offers a comprehensive benefits package, including choices for health, vision, and dental coverage, life insurance, short and long-term disability coverage, retirement planning, tax-deferred annuity, and cash match programs. Explore our robust benefit package here: https://www.vcu.edu/hr/benefits
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