CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs
Job Summary
CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
CRA is responsible for collaborating closely with the Country and Regional Clinical Study Teams to ensure study timelines are adhered to and required quality standards are maintained.
Mentor junior staff (Associate CRA and CRA) and act as the escalation point person for CRAs with site-related issues and concerns.
Matching Summary
CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
Skills & Requirements
Must-have
Clinical monitoring activities
ICH guidelines and GCP
Oncology/onco-hematology trials
Site selection and evaluation
Site management and performance tracking
Trial Master File (TMF) and Investigator's Site File (ISF) maintenance
Nice-to-have
Highly motivated, collaborative
Passionate interest in fighting cancer
Operating excellence and innovation
Mentoring junior staff
Subject matter expert
Key Requirements
3-5 years of monitoring experience
BS in a scientific or healthcare discipline
Experience in oncology/onco-hematology global trials preferred
Advanced knowledge of regulatory requirements
Excellent communication and interpersonal skills
Written and verbal communication skills in English and German