With direction, the CTA I is responsible for providing technical and operational support for any work at the site and country level from study start up to close out. CTA Is may concentrate in one or more routine tasks, and be expected to provide support across the whole role as needed. Key tasks supported by the CTA group are:
• TMF filing, quality, maintenance, compliance, and oversight
• Development and delivery of sites’ ISF, and eISF when utilized, and act as primary point of contact for the sites and manage the Site Operations/monitor access to eISF prior to SIV
• Maintain Pfizer Registries and systems as required
• Provide reporting to support management of clinical trials
• Provide support with audit and inspection readiness activities
• Perform customization of site documents
• Coordinate the translation of documents as required
• Manage Physical Archiving needs as required
• Preparation of documents and communications for distribution to and collection from sites, as required
• Supporting site invoice activities
• Contributes to ensuring high quality is the standard for the team.
• Provide support to CTA managers with on-boarding training for new hires as per group needs.
• Utilize internal team support framework to support issue resolution at the lowest level
• Supports continuous improvement opportunities to enhance operational efficiencies.