Irb Manager - Ri Scientific Brackeen

The IRB Manager, under the direction of the Human Research Protection Program (HRPP) Director, provides leadership, coordination, and advanced regulatory knowledge and experience for the Nationwide Children’s Hospital (NCH) Institutional Review Board (IRB). The primary responsibility will be to manage the protocol review process, identify submission processing issues, and independently determine whether the components of the proposed research follow federal, state and local regulations, Nationwide Children’s policies, and accreditation standards.   This position supervises the NCH IRB staff positions.

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.

Human Subjects Protection: Compliance and Oversight

• Maintains current knowledge of Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations, guidance and standards, Institutional SOPs, State and Local Laws, as well as Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation standards.

IRB Operations:

• Manage the work of IRB Coordinators, recommend hiring or disciplinary actions, or provide coaching, training, and mentoring (including CIP certification), as assigned.

• Manage daily operations of the IRB Office, including:
  • Review expedited submissions (0.3FTE)
  • Delegation/assignment of tasks
  • Prioritization of tasks, establishing work priorities and deadlines
  • Direct, supervise, and coordinate administrative and clerical functions
  • Ensure IRB Coordinators review assigned protocols for completeness, consistency, and compliance with federal and state regulations and institutional guidelines
• Provide supervisory support for the IRB Convened Board(s) team
  • Direct the maintenance of updated member roster, meeting schedules, agenda preparation, submission review and processing, working with PIs to address concerns prior to the meeting, preparation of detailed minutes, record keeping, providing modifications to the PI, reviewing modifications, and maintaining records
  • Provide advice, consultation, assistance, and dissemination of information to IRB board and staff as needed
• Address issues/concerns raised by and with IRB staff in consultation with the HRPP Director
• Provide support, as needed, to the IRB chairs on federal regulations and institutional regulations involving research with human subjects
• Improve efficiency of the IRB office through program enhancements, process improvement, problem solving, and defining reporting, product, and information needs
• Enhance relationships between the IRB Office and researchers
• Represent the IRB Office in discussions with others
• Direct the review of emergency requests, protocol modifications, continuations, and adverse event reports for completeness in compliance with regulations, providing recommendations, with supporting materials, for disposition of protocols
• Collaborate with the HRPP Director with annual reviews of IRB Coordinators
• Assist in strategic planning for AAHRPP Accreditation and the HRPP more broadly
• Collaborate with IT to update and maintain the IRB website and eIRB2 system
• Evaluate, develop, and modify forms/documents to aid the IRB office, IRB members, and researchers
• Collaborate with the HRPP Director to prepare budget recommendations for the IRB Office
• Maintain an in-depth understanding of current, relevant law and regulations, guidance, and policies surrounding human research subject protections and develop a culture of regulatory compliance
• Maintain the ability to interpret legislation, regulations, policies, procedures, and ethical principles in research compliance, serving as a lead for IRB Coordinators
• Participate in continuing education and national and/or regional organizations devoted to the promoting research ethics, the protection of human subjects.
• Serve as a delegate for the HRPP Director, as needed

Assist with special projects as needed.

• Other duties as assigned

Knowledge, Skills & Abilities: Required Licenses/certificates/registrations: CIP (Certified IRB Professional) preferred.

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 10 years of experience in regulatory compliance and/or IRB experience required.
• Additional Technical Requirements
  • Must have a strong knowledge in human subject research, federal regulation governing research, including ICH-GCP, HIPAA regulations, and previous experience with AAHRPP accreditation standards.
  • Sufficient professional experience, adequate education, and sound judgment to comprehend, interpret, and analyze publications and reports concerning applicable policies, procedures and regulations on human subject research issues.
  • Supervisor experience required.
  • Excellent written and oral communications skills.
  • Ability to work independently and as part of a team inter-dependently with co-workers.
  • Ability to work effectively with individuals at all levels of the organization.
  • Must be mature, self-motivated and responsible; must be able to initiate and complete routine and non-routine tasks.
  • Ability to effectively plan and organize projects impacting the work of others.
  • Ability to manage high workload volumes and rigid deadlines.
  • Flexibility to modify work schedule and practices to meet job requirements.

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/Vet