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.
  
  

• 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.
  
  

• 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.