CTA

As an important member of the clinical team you will be responsible for administrative support of all study-related activities. This includes start-up activities, study related documentation, logistical arrangements and working with operations, site and regulatory staff. Your tasks will include

Study start up activities
- Coordinating preparation of local study documentation relating to: clinical study timelines for all studies conducted in a country, recruitment plans and strategy, informed consent form, draft clinical metrics reports
- Preparing and maintaining local study documentation
- Reconciling study documents
- Collating study specific data and generating local metrics reports
- Coordinating local data entry into study management systems
- Creating and completing tracking documentation as applicable
- Processing, distributing and tracking essential documents and submitting them in compliance with SOPs
- Ensuring provision of appropriate clinical documents to support regulatory submission
- Preparing and tracking confidentiality agreements
- Collating and distributing study supplies to sites
- Providing support responding to local audits and inspections
- Responding to clinical trial queries
- Ordering, processing and tracking Case Report Forms (CRF) and following-up on query resolution if required
- Acting as a single contact point for Clinical Trials Insurance process
- Coordinating the preparation of the submissions and local tracking of applications to IRB/ IEC
- Initiating and validating payment requests as required, ensuring that payment requests are within contract and based on milestones
- Completing tracking documentation as applicable including but not limited to spreadsheets, study and contract tracker

As a Clinical Trial Assistant at ICON, you’ll work with a collaborative and successful team to support our Clinical Trial Management and Project Management teams with operational activities. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

The role:
• Provide Support to various projects
• Maintain and Tracking clinical study documentation
• Coordinate study materials
• Collate relevant study information.

You will need:
• Strong Administrative skills
• Organizational skills to support several team members.
• Excellent written and verbal communication
• Working Knowledge of computer systems including Microsoft Word, Excel, Outlook and PowerPoint
• High school diploma or local equivalent

Working experience in an administrative role, preferably within clinical research (CTA experience ideal)

-     Good working knowledge of common software packages

-     Ability to work independently but also to be a constructive team member

-     Strong time management an communication skills

-     Attention to deal

-     Fluency in English (oral and written)

-     University degree

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