We are seeking an IRB Specialist II- the primary responsibility is for staffing the Institutional Review Board (IRB); for ensuring that the IRB’s work is accomplished in a timely manner, for conducting expedited reviews as a designee of the IRB Chair, for assisting IRB Specialist I and other support staff, and for serving as a consultant to clinical investigators at NCH. The IRB Specialist II works closely with the IRB Chair and Vice Chair and reports to directly to the Human Research Protection Program Director. Specialists help ensure that the Hospital’s clinical research activities are in compliance with institutional SOPs and international, federal, state, and local rules and regulations and ethical principles regarding the use of human subjects in research. They ensure that research activities at the Hospital involving human subjects are conducted in a manner that protects the safety, rights, and welfare of participants.
What Will You Be Doing?
Human Subjects Protection: Compliance and Oversight:
• Assist in the processing of complex compliance concerns.
• Maintain a current understanding and knowledge of federal and state regulations, state and local law, and IRB SOPs.
• Serve as a consultant to the IRB membership and the institution on matters related to IRB procedures and applicable federal regulations.
• Participate in continuing education and national and/or regional organizations devoted to the promoting research ethics, the protection of human subjects.
IRB Operations: Provide IRB Support by performing the following tasks:
• Perform IRB reviews as a Designee of the IRB Chair.
• Responsible for the ensuring timely processing, pre-review and disposition of assigned protocols, modifications, continuing reviews, unanticipated problems involving risks to subjects or others, and investigator responses.
• Perform screening/review of submitted protocols to ensure completeness and conformance with IRB SOPs.
• Prepare agenda and minutes for committee meetings in accordance with SOPs.
• Work closely with, and in support of, the IRB Chair, Vice Chair, reviewers and other members.
• Participate in all relevant institutional research educational activities related to human subject protections and IRB operations.
• Maintain and ensure retention of all required IRB records, communications and other documents.
Contacts with others
• Assist in the coordination of IRB activities with other Divisions and Departments.
• Provide education and training on use of IRB electronic management system with the research community.
• Timely communication with investigators/designees regarding IRB submissions.
Assist on special projects as required
• Perform Quality Assurance Reviews of Specialists I’s work and provides constructive feedback.
• Assists on special projects as needed.
• Lead institutional research educational activities related to IRB expertise and human subject protections.
• Represent the Office in relevant forums in the Hospital.
• Design and maintenance of IRB electronic management system.
• Assist in training of new IRB office personnel.
What Are We Looking For?
To fulfill this role successfully, you must possess these minimum qualifications and experience
Required Licenses/certificates/registrations None. CIP Encouraged. Required Education and Experience
BA/BS degree (biology, psychology or other clinical research-related area) required; Masters or other advanced degree preferred; equivalent combination of experience and education will be considered.
Minimum of 4 years of experience in IRB administration, clinical research, or other human subject protection-related job. Direct and obvious relevance to regulatory compliance and research with human subjects Additional Technical Requirements
Skills and knowledge of federal regulations pertaining to research, ICH GCP, HIPAA at a level sufficient to function independently as a consultant to clinical investigators
Knowledge of clinical research and familiarity with medical terminology
Ability to interpret research protocol information in relation to federal guidelines and internal policies, exercise sound judgment and make recommendations and/or decisions regarding research policies for discussion with the Committee and/or Committee Chair.
Excellent written and oral communications skills.
Demonstrated ability to work as a team member
Ability to work effectively with individuals at all levels of the organization.
Excellent time management skills with ability to independently prioritize, organize and efficiently deal with a multiple ongoing activities
Must be mature, self-motivated and responsible; must be able to initiate and complete routine and non-routine tasks
Familiarity MS Word required; experience with computerized databases and MS Windows operating system environment helpful.
Internal Number: 2020-24782
About Nationwide Children's Hospital
Research at Nationwide Children's
The Abigail Wexner Research Institute aggressively supports the discovery of new knowledge and its translation into novel therapeutics and diagnostic tests to advance pediatric research. Unprecedented investment and inspired leadership have paved the way for tremendous progress. The impact on children who previously had little hope has been truly remarkable.
Our investigators traverse the spectrum of pediatric research from discovery science to population health with the common goal of improving the health and quality of life for children and their families. We recruit and train some of the brightest and most innovative researchers and clinician-scientists in pediatrics. Our researchers’ dedication and commitment enable them to work together to accomplish more than could be imagined independently.
Here, discovery, translation and team science aren’t just ideals. They are our foundation as we seek answers on behalf of children everywhere.