Senior Clinical Trial Coordinator
3 weeks ago
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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