Clinical Study Start Up Associate
12 months
Witney - 5 days per week on-site
Purpose of the role:
* Support and assist with all aspects of clinical study(s) start-up, across all geographies.
* Provide input into activities that support study approvals & set up, ensuring these are performed according to study plan and country specific regulations/guidance.
* Ensure understanding and application of country-specific study requirements, prior to undertaking tasks.
Main Responsibilities:
1. Drafts study documents (e.g., consent, patient information sheets, advertisements, etc.), as required
2. Responsible for tracking and filing essential study start-up documents, ensuring compliance with essential study start-up documentation requirements; and supporting archiving throughout the study lifecycle.
3. Utilise and update departmental and study specific systems, as applicable, regarding Investigator contracts and related documents (e.g. CTMS) to ensure timely updates and tracking
4. Provide support with Investigator contracts and budgets, and track status, including invoice reconciliation
5. Support content development and delivery of study-related training
6. Ensure that clinical study start up activities are conducted to meet internal and external standards and guidelines
7. Support testing of sys...