Clinical Research Associate II (Remote, Denmark)

Job summary

This position is for Clinical Research Associates (CRAs) with a focus on managing clinical trial sites across various sponsors, offering exposure to multiple therapeutic areas and opportunities for professional development in a global setting.

Qualifications

• Minimum of 2 years of experience in clinical monitoring.
• Preferably at least 1 year of experience in oncology studies.
• Degree in life sciences or a related field, or equivalent experience.
• Strong understanding of ICH GCP and clinical trial processes.

Responsibilities

• Manage clinical trial sites according to SOPs, ICH GCP, and sponsor requirements.
• Conduct all types of monitoring visits including pre-study, initiation, routine, and close-out visits.
• Ensure patient safety by verifying informed consent and adherence to protocols.
• Maintain data integrity through source data verification, query management, and data review.
• Keep site regulatory documentation and electronic trial master file (eTMF) updated.
• Oversee the handling, storage, and accountability of investigational products.
• Ensure compliance with quality standards and CRA metrics, and prepare necessary documentation.
• Train site staff and verify subject eligibility and protocol compliance.
• Identify and resolve data discrepancies and deviations efficiently.
• Collaborate with study teams to meet timelines and deliverables.

Skills

Additional Information

• Strong organizational, problem-solving, and communication skills.
• Ability to work independently with minimal supervision.
• Experience with serious adverse event reporting and clinical data review.
• Willingness to travel approximately 60% to study sites.