Description de l'offre
You will be responsible for:
· Responsible for the management of designated sites in clinical trial including:
· Site assessment
· Preparation of the monitoring plan and execution in compliance with visit frequency and all assigned tasks throughout the study.
· Planning and Execution of Study Logistics Plan, including eventual delegation of activities to Support Group
· Safety and proper conduct throughout the trial
· Site specific data management
· Mentoring and coaching new CRAs
· Running studies mostly independently
· Contributing country specific aspects in the development of protocol, protocol revisions, amendments and CRF design.
You should have:
· Bio-medical related scientific degree; can vary from a bachelor, master and nursing qualifications.
· More than 3 years of experience as CRA, 2-5 years of Clinical laboratory experience
· Knowledge of applicable standards an regulations for clinical trials and lab conduct (International Conference on Harmonization / WHO Good Clinical Practice standards (ICH-GCP), IVD directives, FDA regulations
· Practical experience in study monitoring according to global standards (ICH)
· Ability to work in local and global study teams, incl virtual teams, cultural awareness
· Who we are