Senior Study Operations Coordinator
hace 2 días
Senior Study Operations Coordinator
About ICON PlcICON plc is a leading global healthcare intelligence and clinical research organization.
Job SummaryWe are seeking a Senior Study Operations Coordinator to join our diverse and dynamic team. As a Sr. Study Operations Coordinator 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.
- 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.
- Fluency in English and Spanish.
A competitive salary of $70,000 - $90,000 per year, depending on experience.
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, TELUS Health, 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.
Lifetime assurance.
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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