Clinical Research Associate 2

As a CRA 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 Research Associate ( CRA II & SeniorCRA) in Bulgaria to work on diabetes, obesity, and rare blood and endocrinology studies.

This particular CRA role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.

What you will be doing:

• • • • • The CRA is responsible for the initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
        • Primary point of contact between site staff and the sponsor.
        • Acts as ambassador for the company and contributes to making the sponsor the preferred partner.
        • Performing on-site monitoring visits according to plan, document actions and follow up on action plans
        • Site feasibility visits incl. analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies
        • Train and guide site staff in the protocol and trial procedures to minimise protocol deviations (PDs)
        • Train site staff in safety information handling and systems
        • Identify potential risks and proactively take action to prevent or mitigate
        • Collaborate with Data Management/logistics in resolving queries
        • Collection and management of essential documents
        • Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
        • Participation in Investigators Meetings to ensure relations with sites as well as active presentation as applicable

Requirements:

• Bachelor or master degree in Life Sciences or equivalent
• 6-12 months previous experience in independent on-site monitoring of clinical trials
• Ability to build and maintain relationships with sites
• High focus on delivery and quality
• Excellent communication and negotiation skills
• English verbal and writing skills, e.g. enabling understanding of the protocol and study documents as well as writing monitoring reports

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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