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Regulatory Specialist – Study Start-Up

2 hours, 26 minutes ago
Egypt
Contract
Junior
Compliance Manager
Operations
GCP HIPAA
Apply Now
Fast Affordable Solutions

Fast Affordable Solutions

Fast Affordable Solutions provides virtual staffing solutions that connect businesses, startups, and executives with highly skilled, English-speaking professionals, streamlining the hiring process to be fast, affordable, and efficient while also offeri...

Professional Services
Founded 2021
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Description

  • Prepare, compile, and submit regulatory documents to IRBs/ECs.
  • Support study start-up activities, including vendor access and regulatory collection.
  • Prepare documentation for SSVs, PSVs, and SIVs.
  • Support migration from Complion to Florence eRegulatory.
  • Perform data entry, document cleanup, and quality control during migration.
  • Create and organize eISFs in Florence.
  • Ensure documents are audit-ready and accurately filed.
  • Prepare FDA 1572s, FDFs, PSPs, and IB acknowledgments.
  • Route documents for signatures and follow up to completion.
  • Maintain CVs, licenses, and GCP documentation.
  • Partner with coordinators, investigators, and sponsors.
  • Track timelines and proactively resolve delays.

Requirements

  • 2+ years of clinical research regulatory experience required.
  • Knowledge of ICH/GCP, FDA regulations, and HIPAA.
  • Experience with eRegulatory systems, with Florence preferred.
  • Strong attention to detail and organization.
  • Ability to manage multiple timelines.
  • Strong communication skills.
  • High school diploma required; bachelor’s degree preferred.
  • Current GCP certification preferred.

Benefits

  • Flexible, remote-friendly work environment.
  • Opportunity to grow into a full-time role and expand responsibilities.
  • Exposure to global clinical research operations and technology.
  • Hands-on experience with Florence eRegulatory.
  • Collaborative, high-growth, and entrepreneurial environment.
  • Ongoing professional development and training opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

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