Study Start-Up Clinical Research Associate

CRA I SSU

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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%)

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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