Location: Orlando, FL, 32811, US
Job Summary:
1. Job Duties and Scopes:
- Lead the company’s Compliance Team and oversee regulatory affairs, data management, and quality assurance.
- Develop and maintain quality assurance standards, compliance plans, and risk analyses.
- Oversee audits, inspections, and ensure "inspection readiness" across all sites.
- Provide regulatory guidance, prepare reports, and manage compliance issues with IRBs and sponsors.
2. Required Skills:
- Strong analytical and critical thinking abilities.
- Excellent communication and presentation skills.
- Ability to lead teams and manage multi-faceted projects.
- Detail-oriented with a drive for results and process improvements.
3. Required Experiences:
- Minimum three (3) years in clinical research compliance and quality assurance.
- At least two (2) years conducting internal audits or inspections.
- Proven team management experience for a minimum of three (3) years.
Job URLs: