Regulatory Compliance Expert

1 month ago


Newport Beach, California, United States BAHAMA Consulting Full time

Job Summary

We are seeking a highly skilled Regulatory Compliance Expert to join our clinical research team at BAHAMA Consulting. The successful candidate will support clinical research teams and ensure compliance with regulations throughout the trial's duration.

About the Role

  • Understand current regulatory requirements and facilitate the study start-up approval process.
  • Maintain accurate and up-to-date regulatory files and ensure all research studies are compliant with regulations.
  • Serve as the central resource for regulatory staff conducting clinical research and work closely with Investigators and Research Staff on new studies.

Responsibilities

  • Track each protocol through the IRB/subcommittee approval process, evaluate recurrent problems, and develop systems to decrease delay in the approval process.
  • Work with sponsors to ensure all proper regulatory documents are approved and that all documents, access to CRF and databases, monitoring/auditing requirements have been completed prior to the start of a study.
  • Obtain and complete all required documents for new submissions, exemption requests, compassionate uses, amendment applications, continuing review, and closure activities.
  • Complete the External Visitors Checklist to meet badge requirements for access to institution.
  • Review informed consents for institutional language and work with legal and sponsors to ensure CTA language is consistent with consent.

Requirements

  • Bachelor's Degree – Required
  • 5 years minimum of regulatory documentation experience in clinical research – required
  • Experience with opening trails, filling applications and submissions for Phase 1 trails

What We Offer

  • Estimated Salary: $77K - $119K per year
  • Medical, Dental, Vision, HSA, Employee Assistance Program (EAP), STD, LTD, Life and 401(K)

About Us

BAHAMA Consulting is an equal opportunity employer. If you need accommodation for any part of the application and hiring process or have any questions, please contact HR.


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