Clinical Research Associate II (On-site, Denmark)

Job summary

This position is for future opportunities as a Clinical Research Associate (CRA) focusing on a diverse range of studies across multiple sponsors. The role emphasizes the development of monitoring expertise in various therapeutic areas while adhering to high-quality standards.

Qualifications

• Minimum 2 years of experience in clinical monitoring
• Preferably over 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

On-site Monitoring Responsibilities

Additional 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
• 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 audit readiness and quality standards
• Prepare monitoring plans, visit reports, and other study documentation
• Train site staff to ensure they are equipped to conduct the study
• Verify subject eligibility, consent, and compliance with protocols
• Review source data for accuracy and completeness
• Identify and resolve data discrepancies and deviations
• Perform monitoring activities in accordance with SOPs and travel policies
• Submit timely and accurate visit reports
• Track study progress, investigational product shipments, and serious adverse events
• Collaborate with study teams to meet timelines and deliverables
• Support investigator and site management activities
• Work with Clinical Trial Management Systems (CTMS) and other eClinical systems
• Attend investigator meetings and project calls
• Provide site training and assist in onboarding new team members
• Contribute to study planning and monitoring strategy

Skills

Additional Information

• Strong organizational, problem-solving, and communication skills
• Ability to work independently with minimal supervision
• Experience with Serious Adverse Event (SAE) reporting and clinical data review
• Willingness to travel approximately 60% to study sites.