Regulatory Compliance Specialist

6 days ago


Newport Beach, California, United States BAHAMA Consulting Corporation Full time

At BAHAMA Consulting Corporation, we are seeking a skilled Regulatory Compliance Specialist to join our team.

About the Role

We offer a competitive salary of $77K - $119K Annual DOE and a comprehensive benefits package, including Medical, Dental, Vision, HSA, Employee Assistance Program (EAP), STD, LTD, and Life insurance.

This is an exciting opportunity for someone with experience in clinical research regulatory coordination to work with our team to ensure compliance with regulations and maintain accurate documentation.

Key Responsibilities:
  • Regulatory Coordination: Facilitate the study start-up approval process, ensuring all research studies comply with federal, state, and local regulations.
  • Documentation Maintenance: Maintain up-to-date regulatory files, tracking each protocol through the IRB/subcommittee approval process.
  • Team Collaboration: Work closely with investigators, research staff, and sponsors to ensure timely, accurate submissions to the IRB and sponsors.
  • Knowledge Management: Stay informed of current regulations, communicating changes to the study team and implementing systems to minimize delays in the approval process.
Requirements:
  • Bachelor's Degree – Required
  • 5 years minimum of regulatory documentation experience in clinical research – required
  • Experience with opening trials, filling applications, and submissions for Phase 1 trials
Why Join Us?

As a Regulatory Compliance Specialist at BAHAMA Consulting Corporation, you will have the opportunity to work on a wide range of projects, develop your skills, and contribute to the success of our team. We offer a dynamic and supportive work environment, with opportunities for growth and professional development.


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