Clinical Study Administrator

AstraZeneca•Wilmington, DE

About The Position

Clinical Study Administrator 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. At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Requirements

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.
Bachelor's degree with 3-5 years of experience in clinical trials and regulatory documents or similar
Accountable and inquisitive; thinks "outside the box"
Must be methodical, compliant to processes yet flexible when needed
High ability to manage priorities and Local Study Team expectations
Independent yet able to work cohesively with a team

Nice To Haves

Veeva experience a plus

Responsibilities

Assists in coordination and administration of clinical studies from the start-up to execution and closeout.
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”.
Ensuresthat 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).