Country Approval Associate

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

📋 Description

• Prepare, review, and coordinate local Ethical Committee submissions in accordance with global submission strategy and under guidance.

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

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

• Ensure submission processes are aligned with the critical path for site activation.

• Meet company target cycle times for site activations.

• Reach out to investigators for activities related to submissions as needed.

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

• Collaborate with start-up CRAs to create regulatory compliance review packages.

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

• Support grant budget and payment schedule negotiations with sites.

• Enter and maintain trial status information within tracking databases.

• Prepare, establish, and maintain local country study files and filing processes.

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

⛳️ Requirements

• Bachelor’s degree or equivalent relevant formal academic/vocational qualification.

• Prior experience of 0 to 2 years in a comparable role.

• Strong oral and written communication skills.

• Excellent interpersonal abilities.

• High attention to detail and quality in documentation.

• Proficient negotiation skills.

• Good computer literacy and capacity to learn necessary software.

• Proficient in English language and grammar.

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

• Capability to work collaboratively in a team or independently under direction, as needed.

• Basic organizational and planning abilities.

• Fundamental knowledge of relevant regional/national regulatory guidelines and EC regulations.

• Willingness to work standard office hours (40 hours/week).

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

• Capability to utilize required personal protective equipment.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Provision of protective eyewear, garments, and gloves as necessary.