IRB Submissions & Ethics Compliance Specialist II

nationwidechildrens

North Carolina

On-site

USD 52,000 - 78,000

Full time

2 days ago
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Job summary

The Abigail Wexner Research Institute (AWRI) at Nationwide Children's Hospital seeks an Administrative Coordinator to support regulatory committees and manage protocol submissions under federal, state, and local rules. This role ensures ethical conduct of research, protects participant safety and welfare, and coordinates across PIs, study teams, and regulatory staff to maintain compliant workflows.

Responsibilities include technical and administrative support for submissions, tracking pending

Qualifications

  • Bachelor's degree required.
  • Three years of regulatory experience required.
  • Experience with protocol submissions and AWRI's processes.
  • Strong MS Office skills and written communication ability.

Responsibilities

  • Provides protocol submission related technical & administrative support to Principal Investigators (PIs).
  • Coordinates across the organization and with faculty and staff to support submission, review, and maintenance of regulatory protocols.
  • Serves as the primary resource for investigators regarding organizational review requirements for research protocols.
  • Tracks pending applications and advises PIs on submission status; implements procedures to assist compliance with conditions.
  • Maintains communication with PIs about expirations, delinquent responses, and incomplete submissions.
  • Attends and supports meetings; submits minutes and drafts correspondence; issues approval notices as per committee conditions.
  • Coordinates filing of accreditation applications and maintains records for inspections; ensures quality of regulatory submissions.

Skills

Regulatory knowledge
Effective communication
MS Office proficiency
Independent worker
Team collaboration

Education

Bachelor's Degree
Master's Degree preferred

Tools

eTRAC system

Job description

The Abigail Wexner Research Institute (AWRI) at Nationwide Children's Hospital seeks an Administrative Coordinator to support regulatory committees and manage protocol submissions under federal, state, and local rules. This role ensures ethical conduct of research, protects participant safety and welfare, and coordinates across PIs, study teams, and regulatory staff to maintain compliant workflows.

Responsibilities include technical and administrative support for submissions, tracking pending

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