Clinical Trial Associate I

The Clinical Trial Associate I (CTA) is an essential part of the Local Study Team and is responsible for supporting key site and country level 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 inclusive of site invoice support which enables the efficient execution of clinical trials to high quality standards.

The CTA I:

• Works independently to carry out key tasks using established procedures and methodologies to ensure the completion according to timelines and to required quality standards.

• Contributes to best practices within the team to ensure efficient task support with a high quality output.

• Can deliver specialist work.

ROLE RESPONSIBILITIES

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.

The CTA I could:

• 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.

BASIC QUALIFICATIONS

• Bachelors degree is expected for entry to this role, successful applicants could be studying for a degree concurrently with this role.

• Good to Fluent English Language skill is essential.

PREFERRED QUALIFICATIONS

• Clinical Trial Associate Experience

• Experience training within the pharmaceutical industry (e.g. Intern, Apprentice, or Undergraduate placements)

• Second language is desirable

• Manual handling required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Must be able to work on-site as part of the hybrid working model.

Must speak local language for site location.

The selected candidate will be required to work onsite during the onboarding period, after which a hybrid working model may be considered, subject to manager approval.

Work Location Assignment: Hybrid

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Medical