IRB Specialist II- RI Scientific
Full Time; Benefit Eligible
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.
Why Nationwide Children's Hospital?
The moment you walk through our doors, you can feel it. When you meet one of our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it, too. Welcome to Nationwide Children’s Hospital, where Passion Meets Purpose.
Here, Everyone Matters. We’re 13,000 strong. And it takes every single one of us to improve the lives of the kids we care for, and the kids from around the world we’ll never even meet. Kids who are living healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere.
Ask anyone with a Nationwide Children’s badge what they do for a living. They’ll tell you it’s More Than a Job. It’s a calling. It’s a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere.
Nationwide Children’s Hospital. A Place to Be Proud.
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
Your Benefits, Your Wellness:
As an employer, Nationwide Children’s recognizes the importance of the benefits we offer. We also recognize the importance of balancing your work and personal needs. Our benefits and Employee Wellness package is designed to:
Minimum Physical Requirements: