Remote iCRA: Start-Up Leader, Global Clinical Trials

Parexel; United States; A distancia; USD 70.000 - 110.000; Jornada completa

Descripción de la vacante

Parexel is expanding its Clinical Research Hub and seeks an Initiation Clinical Research Associate (iCRA) to join our team in Latin America—Brazil, Argentina, and Mexico. These are home-based roles offering flexible work from home with strong line-manager support and a connected team.

You will lead start-up activities, manage regulatory submissions, site activation, and protocol amendments from site identification through activation and maintenance.

Formación

• Strong clinical research and study start-up experience.
• Knowledge of CTMS and eTMF processes.
• Excellent oral and written English skills.

Responsabilidades

• Manage site start-up activities from feasibility through site activation.
• Lead regulatory submissions and ensure readiness of regulatory documents.
• Coordinate with IRBs/IEC, ministries of health, and regulators.
• Develop activation strategies and regulatory plans to meet milestones.
• Maintain First Time Quality in documentation and systems.
• Identify and resolve activation, recruitment, and data quality risks.
• Provide site training and system access support.
• Ensure sites remain audit-ready and inspection-ready.
• Collaborate across functions to meet project milestones.
• Communicate progress, risks, and issues to stakeholders.

Conocimientos

Clinical research

Study start-up

Regulatory submissions

MS Office

English proficiency

Educación

Bachelor's degree in Life Sciences

Herramientas

CTMS

eTMF systems

Descripción del empleo

Parexel is expanding its Clinical Research Hub and seeks an Initiation Clinical Research Associate (iCRA) to join our team in Latin America—Brazil, Argentina, and Mexico. These are home-based roles offering flexible work from home with strong line-manager support and a connected team.

You will lead start-up activities, manage regulatory submissions, site activation, and protocol amendments from site identification through activation and maintenance.