Clinical Research Associate II ( CRA )

As a Clinical Research Associate (CRA) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

ICON Bulgaria are currently looking to recruit experienced CRAs to join our FSP team for a global pharma company. This is a sponsor dedicated role that requires to work occasionally at sponsor's offices in Sofia.

Responsibilities:

• 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

Reqiorements:

• Bachelor or master degree in Life Sciences or equivalent
• 6-18 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

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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