Study Start Up Specialist

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.

What you will be doing

• Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.

• Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.

• Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence

• Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.

• Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Your profile

• Bachelor's degree in life sciences or a related field.

• Minimum of 2 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.

• Bilingual (French and English), with the ability to review and process French Canadian clinical documents, including FR ICFs, IRB submissions and approvals, subject materials, and advertisements.

• Experience supporting study start-up activities within a clinical research environment.

• Strong understanding of regulatory documentation and submission processes specific to French Canadian sites.

What ICON can offer you:

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.

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