Clinical Trial Associate / Sr. Associate (Hungarian speaker)
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.
- 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
- 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)