Site Start-up Associate

Job Summary

Joining a dynamic team, the full-time remote Site Start-up Associate I will manage document collection and review, negotiate contracts and budgets, and ensure compliance with regulatory requirements in support of biotech and pharmaceutical companies.

Key responsibilities

• Perform essential document collection and review to meet sponsor and investigator requirements while ensuring compliance with local regulations and ICH/GCP guidelines
• Negotiate local investigator contracts and budgets, producing site-specific contracts and submitting them for review until resolution and execution
• Forecast submission/approval timelines, provide rationale for delays, and serve as the primary contact for project stakeholders during start-up phases

Required qualifications

• Undergraduate degree or equivalent in a clinical, science, or health-related field from an accredited institution or a licensed healthcare professional
• 1-2 years of related experience in health sciences or biology, with a preference for clinical trials support or pharmaceutical industry experience
• Ability to manage multiple tasks effectively in a fast-paced environment with changing priorities
• Proficiency in working accurately within quality expectations and agreed timelines
• Capability to interpret relevant directives and guidelines