Job Description
When our values align, there's no limit to what we can achieve.
Typical Accountabilities:
• Contributes to the selection of potential investigators.
• In some countries, as required, CRAs are accountable for study start-up and regulatory
maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and
tracking of documents for the application process; submission of proper application/documents to
EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
• Trains, supports, and advises Investigators and site staff in study related matters, including Risk
Based Quality Management (RbQM) principles.
• Confirms that site staff have completed and documented the required trainings appropriately,
including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
• Actively participates i...