Looking for a new opportunity working for an innovative global CRO? My client is currently looking for a passionate candidate to take on the role of a Study Start Up and Regulatory Specialist.
- Office based with home based flexibility
- Minimal- no travel
- Flexibility within the position to explore areas of interest
- Research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation and providing updates of local processes and requirements to the Regulatory Intelligence portal.
- Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.
- Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents.
- Identify site issues during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.
- Support the development of start-up plans and essential document checklists.
- Responsible for contracting budget
- Study start-up experience
- Submissions experience
- Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Strong organizational skills
- Dutch and English