CRA II/ Senior CRA, Denmark
On-siteSoborg, Region Hovedstaden, Kingdom of Denmark
Job Summary
Manage clinical trial sites in line with Fortrea SOPs, ICH GCP, and sponsor requirements by performing all monitoring visits, including PSV, SIV, routine, and close-out. Ensure patient safety by verifying informed consent and protocol adherence while maintaining data integrity through SDV, query management, and data review. Oversee investigational product handling, storage, and accountability to ensure audit readiness and compliance with quality standards and CRA metrics. Prepare monitoring plans, visit reports, and study documentation while collaborating with study teams to meet timelines. Submit timely and accurate visit reports, track study progress, and monitor serious adverse events. Willingness to travel approximately 60% to study sites is required.
Required Qualifications
- Minimum 2 years of clinical monitoring experience
- Degree in life sciences or related field (or equivalent experience)
- Strong knowledge of ICH GCP and clinical trial processes
- Ability to monitor independently with minimal supervision
- Experience with SAE reporting and clinical data review
- Strong organizational, problem-solving, and communication skills
- Willingness to travel (~60% to study sites)
Desired Qualifications
- Preferably 1+ year experience in oncology studies
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