Description of the Position
The Clinical Study Assistant assists in the coordination and administration of the interventional study activities and within the Local Study Team to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.
Assist in coordination and administration of clinical studies from the start-up to execution and close-out.
Collect, assist in preparation, review and tracking of documents for the application process (RA / IEC). Interface with Investigators, external service provider and CRAs during the collection process to support effective delivery of a study and its documents.
Serve as local administrative main contact.
Contribute to the production and maintenance of study documents, ensuring template and version compliance. Translate or give the appropriate support with the translation of documents when required.
Contribute to electronic applications / submissions by handling clinical-regulatory documents according to the requested technical standards i.
e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).
Demands of the Position
Previous clinical administrative experience
Proven organizational and administrative skills
Very good knowledge of spoken and written English and Dutch
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