Study Start Up Associate at ICON plc for BS Lifescience- Apply Now!
Are you a life sciences graduate with a passion for clinical research and regulatory affairs? ICON plc is hiring a Study Start Up Associate II to support regulatory submissions and clinical trial initiations from Santiago, Chile. If you have at least two years of experience and want to work in a flexible hybrid setup, this is a great opportunity to contribute to global health advancements.
About the company:ย
ICON plc is a world-leading healthcare intelligence and clinical research organization. Weโre 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.
- Job Title: Study Start Up Associate II
- Location: Santiago, Chile (Homebased)
- Job Reference: JR130046
- Employment Type: Full-time
- Hybrid: Office/Remote
About the role
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 innovative treatments and therapies.
Responsibilities:
- 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.
Requirements:
- 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.
- Excellent communication and interpersonal skills.
What ICON can offer you:
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. Various benefits include healthcare offerings, retirement planning, life assurance, and additional country-specific benefits.
KeywordS: Study Start Up Associate II, Santiago, Chile, Clinical Research, Study Start Up Associate at ICON, Regulatory Affairs, ICON plc, jobs
