Clinical Trial Assistant

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 join our FSP team at ICON Bulgaria.

This is a sponsor dedicated role in wich you will be assigned to a global biopharmaceutical company specialised in diabetes, obesity, and rare blood and endocrinology studies.

The Clinical Trial Assistant (CTA) is an essential part of the Local Study Team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, GCP, SOPs and country regulations. 

Responsibiities:

• • Collaboration with regional, local clinical operations teams and other cross-functional roles to ensure successful planning and conduct of clinical trial within the countries involved.
  • eTMF handling and archiving
  • Timely uploading of trial documentation in electronic filing system
  • Compliance check of electronic filing system
  • Oversight of all trial documentation for assigned clinical trial, covering all involved affiliates
  • Organization of local meetings
  • Local Investigator meetings organization
  • Supporting local safety reporting to PIs and Health Authorities
  • Supporting clinical supplies management and tracking all relevant processes
  • Ensure overview of local requirements
  • Providing Investigator Trial Master Files (ITMFs) set-up and core input
  • Ensure timely and adequate archiving at close-out
  • Supporting and tracking trial related payments (e.g. Investigator fees), including invoice processing, PO's and other administrative tasks as relevant

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 6 months of previous Clinical Trial Assistant / Clinical Stydy Administrator experience
• This is a hybrrid role that requires to work in the sponsor's offices in Sofia
• Ability to build and maintain relationships with sites
• High focus on delivery and quality
• Excellent communication and negotiation skills

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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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