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Start-up & Regulatory Specialist I

2 semanas atrás

São Paulo, Brasil Fortrea Tempo inteiro

**Become a Local Expert in Clinical Trial Start-Up**

Be the go-to person for investigative sites, guiding them through the critical start-up phase of clinical trials in a global perspective (focused on North America projects). Your expertise in local regulations will ensure timely and compliant submissions, directly impacting the speed and success of vital research.

**Your Impact**:

- Serve as the primary contact for investigative sites, ensuring smooth document collection.
- Master local regulatory requirements, providing guidance to EC/IRBs/Authorities.
- Prepare and manage regulatory submissions, ensuring accuracy and compliance.
- Proactively identify and resolve potential start-up delays.
- Act as a knowledge resource, mentoring colleagues in regulatory processes.
- Contribute to efficient site activation and maintenance, upholding the highest quality standards.

**Your Expertise**:

- 2+ years in clinical research or start-up/regulatory processes with strong ICH-GCP and local regulation knowledge.
- Familiarity with investigator start-up documents and the submission process.
- Excellent communication, organizational, and problem-solving skills.
- Ability to build strong relationships with investigative sites.
- Fluency in English and the local language

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