Remote iCRA: Start-Up Lead for Global Trials

Parexel; Argentina; Remote; ARS 102,990,000 - 151,455,000; Full time

Job summary

Parexel is expanding its Clinical Research Hub and adding Initiation Clinical Research Associate (iCRA) roles to join our team in Latin America—Brazil, Argentina and Mexico. These are home-based positions offering flexible work-from-home arrangements supported by dedicated line managers and a tightly connected team.

As an iCRA, you will lead and execute study start-up activities including site identification, activation, regulatory submissions, and documentation quality to ensure timely

Qualifications

• Strong clinical research and start-up experience.
• Experience with regulatory submissions and site activation.
• Excellent English, oral and written.
• Ability to work in global, matrix environments.

Responsibilities

• Manage site start-up activities from feasibility and qualification through site activation.
• Build strong working relationships with investigators and site staff as the primary contact for assigned sites.
• Prepare, review, negotiate, and execute regulatory and site documents, including confidentiality disclosure agreements, informed consent forms, translations, and amendments.
• Coordinate submissions and approvals with Institutional Review Boards, Independent Ethics Committees, Ministries of Health, and Regulatory Authorities.
• Develop and track site activation strategies, timelines, and regulatory plans to support project milestones.
• Maintain accurate, high-quality documentation in clinical trial management, electronic trial master file, and trial master file systems, ensuring First Time Quality.
• Identify, resolve, or elevate site issues and risks related to activation, recruitment, compliance, training, and data quality.
• Support sites with study system access, training requirements, and readiness activities.
• Ensure assigned sites remain audit-ready and inspection-ready throughout the study lifecycle.
• Maintain compliance with ICH Good Clinical Practice guidelines, local regulations, sponsor requirements, and Parexel SOPs.
• Collaborate across functions to achieve project milestones and deliverables, proactively communicating progress, risks, and issues.

Skills

Clinical research

Study start-up

Stakeholder management

Independent work

Global/multicultural environment

Attention to detail

Education

Bachelor's degree in Life Sciences or related field

Tools

Clinical Trial Management Systems

Electronic Trial Master File

Microsoft Office

Job description

Parexel is expanding its Clinical Research Hub and adding Initiation Clinical Research Associate (iCRA) roles to join our team in Latin America—Brazil, Argentina and Mexico. These are home-based positions offering flexible work-from-home arrangements supported by dedicated line managers and a tightly connected team.

As an iCRA, you will lead and execute study start-up activities including site identification, activation, regulatory submissions, and documentation quality to ensure timely