Country Approval Associate

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Prepare, review, and coordinate submissions to country and local Ethical Committees in accordance with global submission strategies and guidance.

• Assist in the preparation of submissions to the local Ministry of Health.

• Collaborate with internal functional departments to coordinate site start-up activities, submission tasks, and agreed-upon timelines.

• Ensure that submission processes are in alignment with the critical path for site activation.

• Meet company target cycle times for site activations.

• Contact investigators as necessary regarding activities related to submissions.

• Serve as a key country-level contact for ethical or regulatory submission activities as required.

• Work alongside start-up Clinical Research Associates (CRAs) to prepare regulatory compliance review packages.

• Contribute to the development of country-specific Patient Information Sheets and Informed Consent Forms.

• Assist in negotiations related to grant budgets and payment schedules with sites.

• Enter and maintain trial status information in company or client tracking databases.

• Prepare, organize, and uphold local country study files and filing processes in accordance with applicable procedures.

• Stay informed of relevant SOPs, directives, and current regulatory guidelines.

⛳️ Requirements

• Bachelor's degree or an equivalent and relevant academic/vocational qualification.

• 0 to 2 years of prior experience, or an equivalent combination of education, training, and related experience.

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• Keen attention to detail and quality in documentation.

• Proficient negotiation skills.

• Competent computer skills with the ability to learn relevant software.

• Good command of the English language and grammar.

• Basic knowledge of medical/therapeutic areas and medical terminology.

• Ability to work effectively in a team environment or independently under direction.

• Foundational organizational and planning skills.

• Basic understanding of applicable regional/national regulatory guidelines and Ethical Committee regulations.

• Capability to work in an office/laboratory and/or clinical setting.

• Ability to utilize required personal protective equipment, including protective eyewear, garments, and gloves.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Reasonable accommodations for individuals with disabilities.

• Commitment to equal opportunity employment.