Clinical Research Associate II (Healthcare, Remote)

Copenhagen, Capital Region
Posted 1 week ago
Healthcare

About the role

Job summary

This role involves significant responsibilities in the management and oversight of clinical trials, focusing on ensuring compliance and data integrity while collaborating with site staff and investigators.

Qualifications

  • Bachelor's degree in a scientific or healthcare-related discipline.
  • At least 2 years of experience as a Clinical Research Associate.
  • Experience in oncology is advantageous.
  • Comprehensive understanding of clinical trial processes, regulations, and ICH-GCP guidelines.
  • Strong organizational and communication skills, with a keen attention to detail.
  • Ability to work both independently and as part of a team in a fast-paced environment.
  • Willingness to travel at least 60% of the time, with a valid driver's license required.

Responsibilities

  • Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials.
  • Ensure protocol compliance, data integrity, and patient safety throughout the trial process.
  • Collaborate with investigators and site staff to facilitate smooth study conduct.
  • Perform data review and resolve queries to maintain high-quality clinical data.
  • Contribute to the preparation and review of study documentation, including protocols and clinical study reports.

Skills

  • Strong organizational and communication abilities.
  • Attention to detail and ability to manage multiple tasks effectively.

Education

  • Bachelor's degree in a relevant field.

Tools

  • Familiarity with clinical trial management systems and data analysis tools.
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