IRB Specialist II - RI Scientific

at  Nationwide Childrens Hospital

Overview:
The IRB Specialist II is responsible 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 follow 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 feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children’s Hospital, Where Passion Meets Purpose.
Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission.
We’re 14,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we’ll never meet. Kids who live 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.

Responsibilities:

• Assist in the processing of complex compliance concerns.
• 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.
• 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.
• 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.
• Perform Quality Assurance Reviews of Specialists I’s work and provides constructive feedback.
• 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.

Qualifications:
Education: 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.
Certifications: CIP preferred.

Skills:

• Demonstrates ability to analyze and apply Federal, industry regulatory agencies and AWRI’s policies.
• Demonstrates written and oral communications skills.
• Demonstrates working knowledge of research terminology.
• Demonstrates ability to work both independently and in a team-oriented environment, to follow through on assignments with minimal directions, and to independently prioritize work.
• Proficient in Microsoft Office Suite software.

Experience:

• 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 multiple ongoing activity
• 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.

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision. EOE M/F/Disability/Ve

• Assist in the processing of complex compliance concerns.
• 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.
• 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.
• 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.
• Perform Quality Assurance Reviews of Specialists I’s work and provides constructive feedback.
• 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