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ICON plc

Clinical Trial Associate
CambridgePermanentOn-SiteFull-TimeMid-Level

Posted yesterday

Description

We are hiring a Clinical Trial Associate to start immediately or with 1 month notice maximum to join our dedicated team in Cambridge (England/UK).

You will have the opportunity to join a well-established team of dedicated CTAs providing key clinical trial administration support to exciting clinical trials. To succeed, you will demonstrate good UK clinical trial coordination with the ability to multi-task and work in fast-paced working environments.

The Role and Responsibilities
  • Responsible for study start-up activities, including creating site folders, collating, preparing and maintaining (e) SIP documents, updating systems
  • Liaise with clinical sites to collect, review and track feasibility questionnaires
  • Co-ordinates entry and maintain local data into study management systems (eClinical, CDSS/CDSSR, SADMS, etc.) including setting up new studies in eClinical
  • Ensures collection, review, track and provision of appropriate clinical documents to support regulatory submission and to perform IRB/IEC submissions including when appropriate preparation and submission of all documents to the central and/or local committee
  • Track and maintain adequate study related supplies in the office and facilitate their distribution to sites, including preparing and distributing Study File Binders, study drugs and Site Initiation presentations/materials
  • Organise and participate in Investigator meetings and monitor workshops as required within budget guidelines
  • Processes, reconciles, distributes and tracks essential documents and submits them to RIM/EPIC or local archive in compliance with client’s SOPs
  • Orders, processes and tracks Case Report Forms (CRF) and follows up on query resolution
  • Manage local distribution of Investigator Brochure
  • Prepare and review site communication documents; facilitate mass mailings/faxes
  • Provide administrative support such as word processing, photocopying, faxing, filing, managing correspondence, presentations preparation, basic computer software support

Responsibilities:
  • Interacts with Clinical Research Services Manager for project or study related work
  • Supports the execution of clinical studies
  • Responsible for study start up activities
  • Tracks study related documents
  • Manages logistics and document exchange between clinical sites and the company
  • Actively contributes to results oriented department goals
  • Drives continuous improvement of GCSM
  • Promotes operational and scientific excellence within local GCSM
  • Identifies opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness

What is Offered
  • Office-based 5 days per week in the Cambridge office (England/UK)
  • Full-time
  • Salary will be offered depending on the level of experience and skills
  • Permanent contract of employment with ICON and 100% dedicated to 1 single sponsor

What is required:
  • Ideally BA/BS/BSc or qualified nurse
  • UK-based clinical trial co-ordination/administration experience gained within the clinical research industry or within NHS trust/hospital setting
  • Proven ability to work efficiently and accurately with MS Office and EDC systems
  • Ability to work effectively within a fast-paced working environment using different electronic systems
  • Excellent and accurate attention to detail when entering data onto systems/database
  • Valid, current UK working eligibility
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ICON plc

A world leading clinical research organisation accelerating drug and device development globally

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