Associate Study Start-Up Specialist

📋 Description

• Support study start-up activities, initial submissions, and regulatory processes.
• Coordinate site start-up processes from site selection to activation.
• Prepare submission dossiers for Ethics Committees and Regulatory Authorities.
• Support informed consent documentation (ICF) prep, review, and tracking.
• Manage essential study documents with accuracy and timeliness.
• Maintain start-up information in CTMS where applicable.

🎯 Requirements

• Bachelor’s degree or higher in a scientific/healthcare field preferred.
• Minimum 1 year of experience in clinical research/operations or related fields.
• Knowledge of clinical trial execution and ICH/GCP guidelines.
• Familiarity with local regulatory requirements and documentation.
• Experience with site start-up, regulatory submissions, or doc management preferred.
• Strong written and verbal English communication skills.

🎁 Benefits

• Full-time employment opportunity.
• Hybrid work model based in São Paulo.
• Opportunity to work in a global clinical research environment.
• Exposure to innovative healthcare and clinical development projects.
• Professional growth through collaboration with international teams.
• Inclusive and collaborative workplace culture.