לוח אפשרויות קריירה - הדרך החכמה להייטק

a global medical device company is looking for CTA
The Clinical Trial Assistant in gather and the preparation of document for clinical trial applications for the submission and approval from the competent authority and ethical committees.
The Clinical Trial Assistant is responsible for the correct filing and archiving of clinical trial documents.
To provide general administrative support to the Clinical Operations Department .
To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
To support the Clinical Operations teams with ongoing site contacts.
To be familiar with GCP.
To be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.
To assist project teams with study specific documentation and guidelines as appropriate.
To assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
To contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
To assist in the tracking and distribution of safety reports.
To co-ordinate document translation, if required.
To attend project team meetings and generate meeting minutes.
Other duties as assigned

דרישות:

Degree in medicine, health care, life sciences or related fields.
Basic knowledge of clinical trial processes and ICH/GCP guidelines.
Strong general administration skills and experience.
Proficient in the use of Microsoft Office.
Well organized with good time management skills.
Fluent in English and in the country's native language.