Study Start Up Associate II

Study Start-Up Associate-II

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 seeking a Study Start Up Associate II to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNvative treatments and therapies.Roles & Responsibilities:You will be a key member of the Study Start-Up team. You will:

• Interact successfully with both internal and external customers
• Exhibit good decision making skills, utilizing all available resources to achieve positive outcomes
• Communicate with investigative sites and internal team members to predict timelines for site activation and ensure all activation requirements are met
• Work on local IRB submissions
• Review and customization if ICFs
• Collect and review essential regulatory documents needed for site activation
• Identify and escalate issues before they become critical
• Adjust quickly to the changes of a dynamic organization
• Update systems in a timely and accurate way
• Be highly organized in an environment with shifting priorities
• Analyse data and metrics relating to the site activation pathway
• Learn and utilize various reporting tool

Your profile

• Minimum of 4 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
• Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

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What ICON can offer you:

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

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.

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