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Clinical Research Associate II

hace 2 meses


Madrid, Madrid, España Reconocida Empresa A tiempo completo

Job Summary

We are seeking a highly skilled Clinical Research Associate II to join our team at Reconocida Empresa in Madrid. As a Clinical Research Associate II, you will play a critical role in the success of our clinical trials by ensuring the smooth execution of site qualification, site initiation, interim monitoring, site management activities, and close-out visits.

Key Responsibilities

  • Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
  • Evaluate overall site performance and provide recommendations for site-specific actions.
  • Maintain a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
  • Assess site processes and conduct source document reviews to ensure accuracy and completeness.
  • Verify clinical data entered in the case report form (CRF) and apply query resolution techniques to drive query resolution to closure within agreed timelines.
  • Utilize available hardware and software to support the effective conduct of clinical study data review and capture.
  • Verify site compliance with electronic data capture requirements and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF).

Requirements

  • Strong knowledge of ICH/GCP Guidelines and relevant regulations.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Strong analytical and problem-solving skills.
  • Proficiency in Microsoft Office and electronic data capture systems.

What We Offer

  • A comprehensive benefits program encompassing physical, mental, and financial well-being.
  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.