About this role

Initiate and coordinate activities during start up towards the compilation of a high quality Investigator Initiation Package (IIP)
Prepare, validate and submit regulatory documents such as completed IIP, Institutional Review Board (IRB) approval forms
Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
Support the compilation of the Central Investigator Review Board package and submissions to approval of the study
Coordinate the timely communication, documentation and responses between client and central ethics committee
Support investigators sites with local IRB workflow from preparation, submission through approval

Minimum 2 years relevant experience in clinical site management
Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
Understand basic medical terminology, GCP requirements and proficient in computer operations
Must be fluent in local language and in English
Good technical skills and ability to learn and use multiple systems

Site Activation Partner I

Key skills