Responsibilities
- Ensure clinical studies comply with FDA regulations, ICH guidelines, and company standard operating procedures
- Coordinate essential document collection, preparation, and IRB/IEC submissions for assigned trials
- Manage administrative support including vendor invoicing, metrics tracking, and contract service provider oversight
- Maintain electronic trial master files with quality control checks and organize documents per company standards
- Develop consent forms, coordinate document translations, and distribute communications to sites and regulatory bodies
Requirements
- Bachelor's degree in scientific field or equivalent with 2+ years clinical trials or operations experience
- Master's degree in scientific field with some clinical trials or operations experience
- Working knowledge of ICH guidelines, Good Clinical Practices, FDA regulations, and EU Directive
- Understanding of clinical operations from study startup through closeout
- Strong organizational and time management abilities with accuracy under changing circumstances
- Proficiency with computer systems and electronic trial master files
- Excellent written and verbal communication with analytical problem-solving skills
Vacancy posted 25 days ago
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