The Clinical Trial Assistant (CTA) is an essential part of the Local Study Team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, GCP, Pfizer SOPs and country regulations. The role collaborates with local study team members and is responsible for multiple tasks that span from study start-up to study close-out which enables the efficient execution of clinical trials to high quality standards.
Works independently to carry out key tasks using established procedures and methodologies to ensure the completion according to timelines and to required quality standards.
With general direction, the CTA is responsible for providing technical and operational support to Local Study Team members from study start up to close out:
CTAs may specialize 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 and 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
At Associate level the CTA may contribute to team projects and initiatives at the country or regional level.
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