Clinical Study Administrator Fixed-term 1-year contract
Job Summary: The Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities from the start-up to execution and close-out, and within the Local
Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.
Typical Accountabilities:
- Assists in the coordination and administration of clinical studies from the start-up to execution and close-out.
- Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate, to Regulatory Authorities for the duration of the study.
- Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
- Serves as the local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
- Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF, including document tracking by ICH-GCP and local requirements.
- Ensures essential documents under their responsibility are uploaded promptly to maintain the eTMF “Inspection Readiness”.
- Ensures that all study documents are ready for final archiving and completion of the local part of the eTMF and supports the CRA in the close-out activities for the ISF.
- Contributes to the production and maintenance of study documents, ensuring template and version compliance.
- Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ANGEL), ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents.
- Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.
- Sets up, populates and accurately maintains information in AstraZeneca tracking and communication
- tools (e.g., CTMS such as VCV, SharePoint, etc) and supports others in the usage of these systems (except countries where there is a specific role dedicated to setting up and updating the systems).
- Prepares and/or supports contract preparation at a site level (except for countries where there is a specific role dedicated to preparing site contracts).
- Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments following local regulations.
- Manages and contributes to the coordination and tracking of study materials and equipment.
- Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.
- Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, Monitors’ meetings, Investigators’ meetings. Liaises with internal and external participants and/or vendors, in line with international and local codes.
- Prepares, contributes to and distributes presentation material for meetings, newsletters and websites.
- Responsible for layout and language control, copying and distribution of documents. Supports 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, and for handling and archiving of study/country-related e-mails.
- Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions
- representatives to facilitate the delivery of study-related documents/material.
- Ensures compliance with AstraZeneca’s Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
- Ensures compliance with local, national and regional legislation, as applicable.
Qualification:
- 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.
- 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.
- Proven organizational and administrative skills.
- Good interpersonal skills and ability to work in an international team environment.
- Computer proficiency.
- Good knowledge of spoken and written English.
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