Hybrid Regulatory Analyst I

Posted last week

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About the role

  • Assist with the preparation and submission of IRB applications, amendments, continuing reviews, and closures.
  • Upload and organize regulatory documents in Florence eBinders (eISF) following institutional SOPs and version control requirements.
  • Maintain tracking logs for training, delegation, protocol versions, and other required regulatory documentation.
  • Enter and update study-related regulatory activity in Velos (CTMS) to support documentation and billing.
  • Ensure study team credentialing and training documentation are accurate and current.
  • Assist with audit readiness and inspection preparation by maintaining organized and compliant eBinders.
  • Support communication with IRBs, sponsors, and internal stakeholders regarding documentation and updates.
  • Ensure protection of confidential data in accordance with HIPAA and institutional standards.
  • Participate in team trainings, internal process reviews, and quality improvement efforts.
  • Perform other duties as assigned by supervisor or leadership.

Requirements

  • Associate’s degree in a scientific, health-related, or business field, OR equivalent combination of education and relevant experience.
  • One year of experience in a healthcare, academic, administrative, or research setting.
  • Experience with Microsoft Office (Word, Excel, Outlook) required.
  • Experience in research administration, IRB submission, or regulatory documentation (preferred).
  • Familiarity with Florence eBinders, Velos CTMS, or other regulatory platforms (preferred).
  • Understanding of clinical research protections, HIPAA, and GCP guidelines (preferred).

Benefits

  • medical, dental and life insurance plans
  • retirement plan options
  • employee and dependent tuition programs
  • generous leave
  • hundreds of employee perks and discounts

Job title

Regulatory Analyst I

Job type

Experience level

Junior

Salary

Not specified

Degree requirement

Associate's Degree

Location requirements

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