Country Approval Associate
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Job Description
Country Approval Associate coordinating ethical and regulatory submissions for Thermo Fisher Scientific’s clinical trials in Brazil. Supporting site activation, regulatory documentation, tracking databases, and study files.
Responsibilities:
- Prepare, review and coordinate country and local EC submissions under guidance and in alignment with global submission strategy
- Support preparation of local Ministry of Health submissions, as applicable
- Coordinate with internal functional departments on site start-up activities and submission timelines
- Ensure submission processes align with the critical path for site activation
- Achieve company target cycle times for sites
- Communicate with investigators on submission-related activities as needed
- Act as a country-level key contact for ethical or regulatory submission activities as needed
- Work with start-up CRAs to prepare regulatory compliance review packages
- Assist in developing country-specific Patient Information Sheets and Informed Consent Forms
- Assist with grant budgets and payment schedule negotiations with sites
- Enter and maintain trial status information in company or client tracking databases
- Prepare, set up and maintain local country study files and filing processes
- Maintain knowledge of PPD SOPs, client SOPs/directives and current regulatory guidelines
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience comparable to 0 to 2 years
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation skills
- Good computer skills and ability to learn appropriate software
- Good English language and grammar skills
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction, as required
- Basic organizational and planning skills
- Basic knowledge of applicable regional/national country regulatory guidelines and EC regulations
- Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
- Ability to work in office/laboratory and/or clinical environments
- Ability to use required personal protective equipment
Benefits:
- Collaboration and development opportunities
- Global team environment
- Exposure to scientific excellence and innovation
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