Clinical Research Associate
hace 6 días
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 be part of our mission to shape the future of clinical development.
Key Responsibilities:- Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
- Coordinate and liaise with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
- Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
- Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
- Participate 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.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Fluency in English and Dutch language.
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a global Employee Assistance Programme.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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