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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:
- Drafts study documents (e.g., consent, patient information sheets, advertisements, etc.), as required
- 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.
- 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
- Provide support with Investigator contracts and budgets, and track status, including invoice reconciliation
- Support content development and delivery of study-related training
- Ensure that clinical study start up activities are conducted to meet internal and external standards and guidelines
- Support testing of systems (e.g., EDC, CTMS, etc.) for study use.
- Ensure all internal systems (e.g. CTMS) reflect current study start-up status.
- Track study registrations, as required
- Support site feasibility assessments, as required
- Maintain professional communication and relationships with external study personnel, as required
- Ensure effective study communications on study start-up status.
- Maintains & provides inputs into database of site feasibility assessments and site performance metrics to facilitate evaluation of suitability of study sites for future studies
- Communicates regularly during start-up period with Study Start Up Specialist and/or extended study team to review country/site status, issues, study timelines.
- Identify any quality and compliance concerns along with study site or study-level issues and support action plan(s) to ensure resolution, with direction.
- Support audit inspection readiness at site and sponsor level.
- Work with Clinical Study Coordinator to ensure supplies are accounted for and shipped to study sites.
- Maintain current knowledge of country regulations, GCP and ISO14155 Guidelines for clinical research.
Experience:
- Experience in applying attention to detail.
- Computer proficiency in Word, Excel & PowerPoint.
- Understanding of, or previous experience within, a clinical research environment preferred
Randstad Business Support is acting as an Employment Business in relation to this vacancy.
