Clinical study administrator (CSA)

Job Title: Clinical Study Administrator (CSA)

Introduction to role

The Clinical Study Administrator (CSA) plays a crucial role in the coordination and administration of study activities from start-up to execution and close-out. Working within the Local Study Team (LST), you will ensure the quality and consistency of interventional study deliverables, meeting time, cost, and quality objectives.

Accountabilities

• Assist in coordination and administration of clinical studies from start-up to execution and close-out.
• Collect, prepare, review, and track documents for the application process. Assist in timely submission of proper application/documents to EC/IRB and, where appropriate, to Regulatory Authorities for the duration of the study.
• Interface with Investigators, external service providers, and CRAs during the document collection process to support effective delivery of a study and its documents.
• Serve as local administrative main contact and work closely with the CRAs and/or the LSM for the duration of the study.
• Maintain operational responsibility for the correct set-up and maintenance of the local eTMF and ISF, including document tracking in accordance with ICH-GCP and local requirements.
• Ensure essential documents under your responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
• Ensure all study documents are ready for final archiving and completion of the local part of the eTMF, supporting the CRA in close-out activities for the ISF.
• Contribute to the production and maintenance of study documents, ensuring template and version compliance.
• Create and/or import clinical-regulatory documents into the Global Electronic Management System (e.g., ANGEL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents.
• Contribute to electronic applications/submissions by handling clinical-regulatory documents according to requested technical standards (e.g., Submission Ready Standards), supporting effective publishing and delivery to regulatory authorities.
• Set-up, populate, and accurately maintain information in AstraZeneca tracking and communication tools (e.g., CTMS such as IMPACT, SharePoint) and support others in using these systems.
• Prepare and/or support contract preparation at a site level.
• Prepare/support/perform Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
• Manage and contribute to coordination and tracking of study materials and equipment.
• Coordinate administrative tasks during the study process, audits, and regulatory inspections according to company policies and SOPs.
• Lead practical arrangements and contribute to the preparation of internal and external meetings (e.g., study team meetings, Monitors’ meetings, Investigators’ meetings). Liaise with internal and external participants and/or vendors in line with international and local codes.
• Prepare, contribute to, and distribute presentation material for meetings, newsletters, and websites.
• Responsible for layout and language control, copying, and distribution of documents. Support with local translation and spell checks in English to/from local language as required.
• Responsible for printing and distribution of documents such as letters and meeting minutes, handling, and archiving of study/country-related emails.
• Interface with Data Management Centre and/or Data Management Enablement representatives to facilitate the delivery of study-related documents/material.
• Ensure compliance with AstraZeneca’s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health, and Environment).
• Ensure compliance with local, national, and regional legislation as applicable.

Essential Skills/Experience

• High school/Secondary school qualifications that support skills and capabilities of the position and ensure successful conduct of responsibilities and appropriate interactions with internal and/or external customers.
• Previous administrative experience preferably in the medical/life science field.
• Proven organizational and administrative skills.
• Computer proficiency.
• Good knowledge of spoken and written English.

Desirable Skills/Experience

• Further studies in administration and/or in life science field are desirable.
• Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH-GCP guidelines.
• Ability to develop advanced computer skills to increase efficiency in daily tasks.
• Good verbal and written communication skills.
• Good interpersonal skills and ability to work in an international team environment.
• Willingness and ability to train others on study administration procedures.
• Excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities.
• Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• Integrity and high ethical standards.

At AstraZeneca, we push the boundaries of science to deliver life-changing medicines. With science at our core, we transform lab breakthroughs into transformative medicine for complex diseases. We strive to understand diverse populations' needs, aiming to provide affordable, sustainable healthcare. Our innovative pipeline promises a bright future. Join us as we lead healthcare advancements globally.

Ready to make a difference? Apply now!