Regulatory & Start Up Specialist 1

About the role

The Regulatory & Start Up Specialist 1 supports clinical studies in Chile, acting as the single point of contact for site activation and regulatory activities. This full‑home‑based role ensures compliance with SOPs, timelines, and quality standards.

Key responsibilities

• Serve as the Single Point of Contact for investigative sites, Site Activation Managers, and project teams, ensuring adherence to SOPs and project timelines.
• Perform start‑up and site activation activities, prepare and distribute regulatory documents, and maintain internal tracking tools.
• Review site regulatory documents for completeness and accuracy, and provide quality control of site‑provided documents.
• Monitor site performance metrics, track document approvals, and implement contingency plans as needed.
• Provide local regulatory expertise to project teams during planning and execution phases.

Required profile

• Bachelor’s degree in life sciences.
• At least 1 year of clinical research and study start‑up management experience.
• Fluent written and oral English.
• Strong analytical, critical thinking, and interpersonal skills.
• Ability to manage multiple priorities in a fast‑paced environment.