Clinical Study Administrator
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), the CSA ensures the quality and consistency of interventional study deliverables, meeting time, cost, and quality objectives.
Accountabilities
- Assists in 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 intimely 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 local administrative main contact and works closely with the CRAs and/or the LSM for the duration of the study.
- 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.
- Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF "Inspection Readiness".
- Ensures that all study documents are ready for final archiving and completion of 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. Enterprise Regulatory Vault ) 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 Veeva Clinical Vault, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems).
- Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts).
- Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
- Manages and contributes to 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 web-sites.
- 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 Enablement 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.
Essential Skills/Experience
- Bachelor's degree in sciences preferred plus 0-3 yrs' experience that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers, or Associates degree in Sciences and 3+ pharmaceutical experience years of experience that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers required.
- Previous clinical study experience with
CDA/start up process preferred.
- Experience working with clinical sites.
- 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.
- 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 are driven by our passion for science. We are committed to making a difference by treating, preventing, modifying, or even curing some of the world's most complex diseases. Our environment fosters lifelong learning where you can develop your career while working on groundbreaking projects. We combine data, technology, and scientific innovation to achieve breakthroughs that positively impact billions of patients worldwide.
Ready to make a difference? Apply now!
The annual base pay for this position ranges from $ 79,822.40 - 119,733.60 . Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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