Study Start Up Associate II
ICON · Sao Paulo, Brazil +1 more
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Study Start Up Associate II role at ICON involving clinical trial initiation and regulatory oversight. The position is based in São Paulo, Brazil or Buenos Aires, Argentina, reporting to a sponsor-dedicated team. Responsibilities include preparing regulatory submissions, coordinating stakeholder approvals, and maintaining trial documentation.
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 project management and organizational skills for multiple concurrent tasks
- Strong communication and cross-functional collaboration abilities
- Willingness to travel approximately 5% as required
What you'll be doing
- Prepare and submit regulatory documents including clinical trial applications and ethics committee submissions
- Coordinate with internal and external stakeholders to obtain study initiation approvals and authorizations
- Maintain comprehensive records of regulatory submissions, approvals, and correspondence
- Provide guidance to study teams on regulatory requirements and best practices for start-up activities
- 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.