Study Start-Up Clinical Research Associate

CRA I SSU

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.

As a Study Start-Up Clinical Research Associate (SSU CRA) dedicated to Novartis, you will play a critical role in accelerating clinical trial startup activities various studies in France. Acting as a strategic partner to internal and external stakeholders, you will lead site selection, startup planning, and readiness-to-screen activities to ensure sites are activated within ambitious project timelines.

What You Will Do You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively.

Key Responsibilities Include

• Lead site selection activities in partnership with Medical Advisors, Principal Investigators, Study Coordinators, and site stakeholders.
• Assess site capabilities and provide strategic recommendations on site selection decisions.
• Manage relationships with site personnel, pharmacies, imaging departments, laboratories, and external vendors.
• Collect and track essential regulatory and study documentation required for site activation.
• Ensure sites achieve Ready-to-Screen status within established timelines and KPIs.
• Accountable for timely start-up activities from country allocation until site greenlight at assigned sites.
• Acts as the main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation.
• Identify risks proactively, provide visibility to stakeholders, and implement mitigation actions.
• Maintain accurate documentation within CTMS and eTMF systems and update all systems until site Green Light on an ongoing basis

Your Profile Required qualifications and experience:

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 2 years of experience as a Clinical Research Associate.
• Previous Study-start up activities experience.
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Strong organizational and communication skills, with attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Willingness to travel as required (approximately 50%)

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