Study Start Up Associate II
ICON · Sao Paulo, Brazil +2 more
Clinical OperationsFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Study Start Up Associate II role supporting North America clinical trial initiation. Lead regulatory document preparation, coordinate stakeholder approvals, and maintain trial records while supporting site activation and process improvements.
What they're looking for
- Bachelor's degree in life sciences or related field
- Minimum 2 years clinical research or regulatory affairs experience with study start-up focus
- Strong knowledge of ICH-GCP and local regulatory requirements for clinical trials
- Excellent organizational and project management skills with multitasking ability
- Strong communication and interpersonal skills for cross-functional collaboration
- Willingness to travel approximately 5% as required
What you'll be doing
- Lead preparation and submission of regulatory documents and ethics committee applications
- Coordinate with internal and external stakeholders to obtain study initiation approvals
- Manage comprehensive records of regulatory submissions, approvals, and correspondence
- Provide guidance to study teams on regulatory requirements and start-up best practices
- Participate in process improvement initiatives to enhance study start-up efficiency
Privacy & handoff
This role links to ICON's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.