Clinical Study Administrator
Company: AstraZeneca
Location: Wilmington
Posted on: January 27, 2023
Job Description:
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.
CSAs might have different internal titles based on the experience
level (CSA, Senior CSA). The experience level depends on the years
of experience, performance record, level of independence in the
role, ability to take on additional tasks or tutor more junior
colleagues. The Director, Country Head may assign this internal
title after confirmation with Senior Director, Cluster Head /
Executive Director, Regional Head.
Job Responsibilities:
- 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 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 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
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. 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 (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,
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.
- Additional country-specific tasks might be added depending on
local needs.
Education:
- High school/Secondary school qualifications (*), that supports
skills and capabilities of the position and ensures 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.
Desired Skills
- 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
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.
AstraZeneca requires all US employees to be fully vaccinated for
COVID-19 but will consider requests for reasonable accommodations
as required by applicable law.
Keywords: AstraZeneca, Wilmington , Clinical Study Administrator, Healthcare , Wilmington, Delaware
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