Clinical Study Administrator - Luton, United Kingdom - AstraZeneca

AstraZeneca

Verified Company

Luton, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Clinical Study Administrator

Location:
Luton
Join AstraZeneca as a Clinical Study Administrator and help us deliver life-changing medicines.

In this role you will assist in the coordination and administration of the clinical study activities and work within the Local Study Team (LST) to ensure quality and consistency of study deliverables to time, cost and quality objectives.

This is a varied clinical administration role where you will get involved beyond the documentation, and will get exposure to administrative support of all aspects of clinical trials from start to finish.

Our clinical studies span a range of therapeutic areas including respiratory, oncology, cardiovascular and metabolic diseases.

You will play an important role in all stages of a clinical study including set up, maintenance and close down activities, and you will have regular communication with hospital trusts and sites as well as key internal stakeholders.

It's a role with lots of scope to learn and progress.

Responsibilities
You will assist in coordination and administration of clinical studies from start-up to execution and close-out.

Specific tasks could include:

Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors
Interfacing with Investigators, external service provider and Clinical Research Associates (CRAs) during the collection process to support effective delivery of a study and its documents.
Operational responsibility to setup the local Trial Master File (eTMF) and Investigator Site File (ISF) including tracking of documents, ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements.
Contributing to the production and maintenance of study documents, ensuring template and version compliance.

Essential requirements

Previous administrative experience preferably in the medical/ life science field.
Experienced user of Microsoft Office suite: Word / Excel / Powerpoint etc
Excellent communication skills
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
Good interpersonal skills and ability to work in an international team environment
Display excellent organization and time management skills, excellent attention to detail, and ability to multitask in a high volume environment with shifting priorities
Team oriented and flexible; ability to work well under pressure and to respond quickly to shifting demands and opportunities

Desirable requirements: