Study Start Up Associate II
ICON · Sao Paulo, Brazil +1 more
Clinical OperationsFull-timeCompany career page
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Role summary
ICON seeks a Study Start Up Associate II to lead clinical trial initiation activities across Latin America. The role focuses on regulatory document preparation, stakeholder coordination, and ensuring compliance with clinical trial requirements in a sponsor-dedicated model.
What they're looking for
- Bachelor's degree in life sciences or related field
- Minimum 2 years clinical research or regulatory affairs experience
- Specific site start-up and activation project experience
- Knowledge of ICH-GCP and local regulatory guidelines for clinical trials
- Strong project management and organizational skills
- Excellent cross-functional communication and collaboration abilities
- Willingness to travel approximately 5% as needed
What you'll be doing
- Lead preparation and submission of regulatory documents including clinical trial applications
- Coordinate with internal and external stakeholders to obtain study initiation approvals
- Maintain accurate records of regulatory submissions, approvals, and correspondence
- Guide study teams on regulatory requirements and start-up best practices
- Support process improvement initiatives to enhance study start-up efficiency
Privacy & handoff
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