Clinical Research Associate II

hace 1 mes


Zaragoza, Zaragoza, España Pharmiweb A tiempo completo
Job Summary

We are seeking a highly skilled Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

You will verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient. You will also assess factors that might affect subject/patient safety and clinical data integrity at an investigator/physician site.

The ideal candidate will have a Bachelor's degree or RN in a related field and knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. You will also have excellent communication, presentation, and interpersonal skills.

This is a full-time position that requires up to 75% travel. If you are a motivated and detail-oriented individual who is passionate about clinical research, we encourage you to apply.

Key Responsibilities
  • Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
  • Verify the process of obtaining informed consent has been adequately performed and documented
  • Assess factors that might affect subject/patient safety and clinical data integrity
  • Manage site-level activities and communication to ensure project objectives, deliverables, and timelines are met
  • Act as primary liaison with study site personnel and ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements
Requirements
  • Bachelor's degree or RN in a related field
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Excellent communication, presentation, and interpersonal skills
  • Ability to manage required travel of up to 75% on a regular basis


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