Country Approval Associate

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

📋 Description

• Prepare, review, and manage Country Submissions under supervision and in accordance with global submission strategies.

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

• Collaborate with internal functional departments regarding site start-up activities and submission timelines.

• Ensure that submission activities are in line with the critical path for site activation.

• Meet company target cycle times for site activations.

• Communicate with investigators on submission-related tasks as necessary.

• Serve as the primary country-level contact for ethical or regulatory submission activities when required.

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

• Assist in creating country-specific Patient Information Sheets and Informed Consent Forms.

• Help negotiate grant budgets and payment schedules with sites.

• Enter and keep trial status information updated in tracking databases.

• Prepare, establish, and manage local country study files and filing systems.

• Stay informed about company and client SOPs/directives as well as current regulatory guidelines.

⛳️ Requirements

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

• Prior experience ranging from 0 to 2 years is preferred.

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• High attention to detail and quality in documentation.

• Proficient negotiation skills.

• Good computer skills with the capacity to learn relevant software.

• Proficient English language and grammar skills.

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

• Ability to work effectively in a team setting or independently under guidance as needed.

• Basic organizational and planning abilities.

• Fundamental knowledge of applicable regional/national regulatory guidelines and Ethics Committee regulations.

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

• Ability to adhere to biological-fluid exposure controls and utilize necessary personal protective equipment.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Work within a global team environment.

• Gain exposure to scientific innovation and make meaningful contributions.