Site Start-up Associate
Job Summary
To support biotech, medtech, and specialty pharma companies, the full-time remote Site Start-up Associate II will manage submission and approval timelines, prepare regulatory applications, and oversee essential document collection to ensure compliance with local regulations and ICH/GCP guidelines.
Key responsibilities
- Forecasts submission/approval timelines and escalates issues as needed
- Prepares and submits Central EC/IRB Applications and other regulatory submissions
- Negotiates site-specific contracts and budgets with local investigators
Required qualifications
- Undergraduate degree in a clinical, science, or health-related field or equivalent
- 3+ years of direct study start-up experience
- Working knowledge of FDA Guidance Documents, EU Directives, and local regulations
- Detailed knowledge of country-specific regulatory requirements for clinical trials
- Proficient in developing and reviewing Informed Consent Form templates
Complete Job Description
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