Senior Clinical Research Associate

hace 3 semanas

Madrid, Madrid, España Icon A tiempo completo

**About ICON**

ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment that drives innovation and excellence, providing opportunities for our employees to grow and develop in their careers.

We are currently seeking a Senior Clinical Research Associate to join our dynamic team. As a key member of our team, 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.

Your 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.

About You:

  • 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.

What We Offer:

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, health insurance options, retirement planning opportunities, and a global employee assistance program.

We are committed to providing an inclusive and accessible work environment for all employees. If you need reasonable accommodations for any part of the application process, please let us know.

We encourage interested candidates to apply, regardless of whether they meet all of the requirements. We believe that our diverse workforce is a key factor in our success and look forward to hearing from you.

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