Senior Clinical Research Associate

Clinical Research Associate ( CRAII or Senior CRA) - Remote - Romania

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently recruiting for experienced Clinical Research Associates in Romania to work on a range of therapeutic areas for a prestigious and global biopharmaceutical company.  This particular CRA role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs.

The Clinical Research Associate is responsible for the preparation, 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.

Responsibilities:

• You will monitor multiple Phase I, II, III & IV clinical trial sites, across different therapeutic areas. Assist other team members with co-monitoring activities both remote and on-site.

• You will utilize your customer service mindset with your sites focusing on delivering value, building loyalty and trust to create a positive impact and strong relationship with investigators and study coordinators where respect, knowledge and commitment to ICH/GCP guidelines are key to successful trial conduct.

• In this role you are the main sponsor representative, providing key project updates. You will collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely.

• As the first point of contact for study sites, escalating any concerns/issues to other departments including Safety, Investigational Medicinal Product, Local Study Managers and management team as appropriate.

• Additionally, you will oversee the sites' adherence to GCP/ICH practices, ensuring quality of study conduct.

Requirements:

• Bachelor’s Degree (or equivalent)

• Minimum 3.5 years of independent on-site monitoring experience/experience as a field CRA

• Ability to travel with overnight stays

• Experience conducting all types of MVs such as: Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site

• A demonstrated working knowledge of ICH/GCP Guidelines

• Excellent record-keeping skills and attention to detail

• Fluent in English and Romanian, both written and oral

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• Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license

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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply