CTA role provides technical support to the clinical trial capabilities team in support of clinical development.  The assistant is responsible for activities related to investigator site readiness, maintenance and close-out.  The assistant will ensure inspection readiness through a complete, accurate and readily available Trial Master File.  Additional country-specific responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

JOB RESPONSIBILITIES

• Initiate investigator site activities such as regulatory document collection and submission, informed consent document customization and negotiation
• Directly communicate with sites to facilitate start-up and sustain active collaboration with sites throughout maintenance and close-out.
• Issues must be identified, communicated with, and resolved.
• Ensure that submission paperwork and any additional documents/systems meet country-specific regulatory and data privacy laws.
• Leverage prior site/review board interactions to efficiently drive new work
• Fill internal systems to assure trial/site performance correctness.
• Understand and follow procurement, legal, and financial requirements, as well as processes.
• Fill out Trial Master Files and libraries for future use.
• Provide feedback and shared learning for continued development
• Utilize trial prioritisation
• Anticipate and monitor constantly shifting priorities

QUALIFICATION

• Bachelor’s degree preferably in a scientific or health-related field, two years of clinical research experience or relevant experience preferred
• Knowledge of the overall clinical development paradigm and the significance of timely site initiation
• Fluency in English and Hungarian is essential
• Applied understanding of project management methods and abilities
• Understanding of and experience in a compliance-driven workplace
• The ability to learn and follow financial and legal policies and guidelines (budget and contract)