Senior 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: This will be a hybrid position; 1-2 days per week will be on site in Aurora, CO and 3-4 days per week will be full remote
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

What You Bring:

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

Job ID: 46438

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