Senior Regulatory Affairs study Start Up Specialist - Raleigh, NC

Only for registered members Raleigh, NC, United States

1 week ago

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Job summary

This position will independently manage essential regulatory documentation for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies. The Regulatory Affairs Specialist will interact with study teams, site personnel, sponsors, and CTI management to facilitate timely collection, assessment and processing of essential regulatory documentation.

Responsibilities

  • Assist/Advise project teams on all regulatory requirements for clinical studies
  • Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings

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