Clinical Research Associate

• Execute clinical monitoring activities at clinical trial sites in accordance with ICH guidelines, GCP, local regulations, and SOPs
• Perform monitoring activities for selection, initiation, conduct, recruitment, quality data collection, and timely completion of oncology/hematology clinical trials
• Collaborate with the Regional Clinical Operations Manager to ensure study timelines and quality standards
• Identify gaps and areas for improvement and propose CAPA
• Support study startup and provide local expertise
• Perform feasibility, site identification, selection, and evaluation
• Provide protocol and study training to assigned sites
• Conduct pre-study, initiation, routine monitoring, closeout, and co-monitoring visits
• Complete monitoring visit reports
• Manage site performance by tracking regulatory submissions, recruitment, CRF completion, and data query resolution
• Establish communication with sites and report progress, issues, and proposed actions to Clinical Operations
• Ensure inspection readiness of studies and sites
• Collaborate with study sites to deliver study milestones, including startup, recruitment, database analyses, and closeout
• Facilitate Study Oversight Visits, site audits, and inspections as required
• Evaluate site practices and escalate quality or GCP issues
• Anticipate site issues and propose corrective and preventative actions
• Promote operating excellence and innovation

• BS in a relevant scientific discipline and minimum of 2 years of monitoring experience
• At least 2 years of CRA monitoring experience in the pharmaceutical or CRO industry
• Experience in oncology global trials preferred
• Experience in oncology/hematology trials preferred
• Thorough knowledge of ICH and associated regulatory guidelines
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Fluent in English and German, writing and speaking
• Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
• Willingness to travel up to 60%