IRB & Research Compliance Specialist II

10 Nationwide Children's Hospital

United States

On-site

USD 65,000 - 95,000

Full time

5 days ago
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Job summary

Nationwide Children's Hospital is seeking an experienced regulatory coordinator to support committees within AWRI. You will manage protocol submissions, ensure compliance with federal, state, and local regulations, and safeguard participant rights and safety.

This role involves coordinating with investigators, tracking submissions, training staff on eTRAC usage, and helping maintain accreditation records. A Bachelor's degree is required, Master's preferred, with three years of regulatory

Qualifications

  • Bachelor's degree required; Master's preferred.
  • Threeyears of relevant research regulatory experience required.
  • Effective communication skills, both written and verbal.
  • Ability to work independently and in a team environment.

Responsibilities

  • Provide protocol submission technical & administrative support to PIs.
  • Coordinate submission, review, and maintenance of regulatory protocols.
  • Serve as primary resource for organizational review requirements.
  • Track pending applications and advise PIs on status.
  • Identify approved protocols and assist with compliance conditions.
  • Maintain communication about expirations, delinquent responses, and incomplete submissions.
  • Act as super-user for the eTRAC system and support process improvements.
  • Provide training to PIs and staff on eTRAC submissions.
  • Collaborate to ensure mandatory researcher training is completed.
  • Attend meetings, seminars, and workshops; draft minutes and correspondence.
  • Issue approval notices based on committee conditions.
  • Coordinate filing of accreditation applications and inspections records.

Skills

Analytical thinking
Regulatory knowledge
Verbal and written communication
Team collaboration
MS Office proficiency

Education

Bachelor's Degree
Master's Degree (preferred)

Tools

eTRAC system

Job description

Nationwide Children's Hospital is seeking an experienced regulatory coordinator to support committees within AWRI. You will manage protocol submissions, ensure compliance with federal, state, and local regulations, and safeguard participant rights and safety.

This role involves coordinating with investigators, tracking submissions, training staff on eTRAC usage, and helping maintain accreditation records. A Bachelor's degree is required, Master's preferred, with three years of regulatory

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