Clinical Research Associate (Life Sciences, Denmark)

Job summary

This role involves monitoring clinical trial sites with a focus on risk-based approaches to ensure compliance and data accuracy. The position is well-suited for Clinical Research Associates currently engaged in the life sciences sector, particularly within pharmaceutical or biotech companies.

Qualifications

• University degree in a science-related field
• Understanding of ICH-GCP, EU, and FDA regulations
• Fluency in English
• Valid driver's license

Responsibilities

• Monitor investigator sites using root cause analysis and problem-solving skills to ensure compliance and mitigate risks.
• Ensure data accuracy through various monitoring activities, including on-site and remote reviews.
• Document observations and escalate issues to clinical management promptly.
• Participate in investigator meetings and assist in identifying qualified investigative sites.
• Initiate and close out clinical trial sites in accordance with protocols and regulations.
• Provide trial status updates and maintain study systems as required.
• Contribute to project publications and process improvement initiatives.

Skills

• Proven clinical monitoring skills and understanding of medical terminology.
• Strong critical thinking and problem-solving abilities.
• Excellent oral and written communication skills.
• Good organizational and time management skills.
• Ability to work independently or as part of a team.
• Proficient in Microsoft Office and adaptable to new software.

Education

• University degree in a science-related field.

Tools

• Familiarity with Clinical Trial Management Systems and Microsoft Office.