As a Clinical Trial Assistant you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

We are currently recruiting for an experienced Clinical Trial Assistant ( CTA) in Bulgaria to work in a sponsor dedicated role.

The Clinical Trial Assistant (CTA) will 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 to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.

Key tasks:

• • 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 Study Managers for the duration of the study.
  • 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.
  • Sets-up, populates and accurately maintains information in tracking and communication tools (e.g. CTMS, SharePoint, etc)
  • Prepares and/or supports contract preparation at a site level
  • 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 vendors
  • Prepares, contributes to and distributes presentation material for meetings, newsletters and websites.
    
    
    

Requirements:

• Bachelors degree is expected for entry to this role, successful applicants could be studying for a degree concurrently with this role.
• A minimum of 12 months of experience in clinical research.
• Previous experience as a Clinical Trial Assistant/ Study Administrator would be an advantage
• Previous administrative experience in clinical research field
• Ability to build and maintain relationships with sites
• High focus on delivery and quality
• Excellent communication and negotiation skills

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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