Responsibilities Performing site evaluation, initiation, monitoring and close-out visits, plus maintaining appropriate documentation according to a project-specific monitoring plan, ICH-GCP, and applicable regulations. Supporting the development of a subject recruitment plan. Establishing regular lines of communication
Assisting PI to administer the clinical trials in accordance with the SOP, ensuring the clinical trials are conducted in accordance with GCP guidelines and quality. Major Responsibilities Describe the tasks, duties, and responsibilities the employee who
Job Overview Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages site documentation; reviews and
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice Job Description Summary of Essential Functions: Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers,