Country Approval Associate

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

📋 Description

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

• Assist in the preparation of local Ministry of Health submissions when necessary.

• Collaborate with internal functional departments to synchronize site start-up activities with submission tasks and established timelines.

• Ensure that submission processes for sites and studies are in line with the critical path for site activation.

• Meet company target cycle times for site activations.

• Reach out to investigators regarding activities related to submissions as necessary.

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

• Collaborate with start-up Clinical Research Associates (CRAs) to compile regulatory compliance review packages.

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

• Support negotiations for grant budgets and payment schedules with sites.

• Enter and maintain trial status information for Site Initiation Activities (SIA) in company or client tracking databases.

• Prepare, organize, and manage local country study files and filing processes.

• Stay informed about PPD and client Standard Operating Procedures (SOPs), directives, and the latest regulatory guidelines.

⛳️ Requirements

• Bachelor's degree or equivalent with relevant formal academic or vocational qualifications.

• 0 to 2 years of prior experience demonstrating relevant knowledge, skills, and abilities.

• An equivalent combination of suitable education, training, and/or directly related experience may be considered.

• Strong oral and written communication abilities.

• Excellent interpersonal skills.

• High attention to detail and quality of documentation.

• Proficient negotiation skills.

• Good computer proficiency and the capacity to learn necessary software.

• Strong English language and grammar skills.

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

• Ability to function effectively in a team environment or independently with direction.

• Basic organizational and planning capabilities.

• Basic knowledge of relevant regional/national regulatory guidelines and Ethical Committee regulations.

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

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

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Workplace focused on scientific excellence.