Sr. Clinical Regulatory Specialist

Lakeshore Talent

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Lakeshore Talent is partnered with a reputable and nationally ranked hospital in their search for a Sr. Clinical Regulatory Specialist. This role will start as a 3 month contract with strong potential for extension and/or permanent hire.

Location: Aurora, CO with hybrid potential
Pay: $39-$41 per hour (depending on experience)

Description:

  • Responsible for the management of complex research protocol documents and activity from initial submission through study closure
  • Primary focus is on the development, submission, maintenance, filing, and reporting of regulatory documents (continuing reviews, amendments, protocol deviations, etc.) while achieving and maintaining compliance with internal, external, and federal policies and regulations
  • Maintain appropriate study documentation including regulatory binders and enrollment logs
  • Discuss regulatory issues with auditors and monitors; explain internal regulatory processes and SOPs as needed
  • Lead the development, improvement, and implementation of SOPs and study specific processes

Requirements:

  • Bachelor’s Degree in a related field
  • Extensive knowledge of IRB processes
  • Experience working with and submitting new drug applications (eINDs, sINDs) to the FDA
  • Excellent communication skills
  • Attention to detail
  • ACRP or SOCRA certification preferred, not required

Job ID: 45523

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