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 CRA(s) 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
ICH guidelines and GCP
monitoring activities
site selection and evaluation
protocol and study training
site management
quality and integrity of site practices
Nice-to-have
highly motivated
collaborative
passionate interest in fighting cancer
operating excellence
promote innovation
Key Requirements
BS in a scientific or healthcare discipline
3 - 5 years of monitoring experience
Experience in oncology/onco-hematology global trials
Advanced knowledge of applicable clinical research regulatory requirements
3 - 5 years of (CRA) monitoring experience
Excellent communication and interpersonal skills
Excellent organizational and problem-solving skills