Senior Clinical Trial Coordinator

3 weeks ago


Newport Beach, California, United States BAHAMA Consulting Full time

Role Summary:

We are seeking a detail-oriented and organized Senior Regulatory Coordinator to join our clinical research team at Bahama Consulting. The ideal candidate will have extensive experience in regulatory compliance and document management.

Responsibilities:

  • Review and analyze regulatory requirements to ensure compliance.
  • Develop and implement procedures to minimize delays in the approval process.
  • Coordinate with investigators and research staff to ensure timely and accurate submissions to the IRB and sponsors.
  • Prepare and maintain regulatory documents, electronic study folders, and other records.
  • Provide training and guidance to junior team members.

Requirements:

  • At least 5 years of experience in clinical research regulatory coordination.
  • Excellent analytical and problem-solving skills.
  • FDA and IRB start-up experience.
  • Working knowledge of NIH, OHRP regulatory requirements, and ICH GCP guidelines.

Salary Range: $85K - $125K Annual DOE



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