Remote CRA II - Italia | Site Monitoring Expert

Syneos Health Careers; Italia; Remote; EUR 38,000 - 46,000; Full time

Job summary

Syneos Health Careers seeks a CRA II for Italia who will work remotely from home. You will perform site qualification, initiation, monitoring and close-out visits, ensuring regulatory and GCP compliance, while maintaining data integrity and patient safety across sites in Italy.

The role requires travel up to 75% and a Bachelor’s degree or RN in a related field, with strong communication skills and comfort with new technologies.

Qualifications

• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis
• US relocation guidance may apply depending on site; deployment to sites as needed

Responsibilities

• Performs site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or GPP and protocol compliance.
• Verifies informed consent processes and protects subject confidentiality; assesses safety and data integrity at sites.
• Assesses site processes; conducts Source Document Review; verifies CRF data accuracy; drives query resolution within timelines.
• May perform IP inventory, reconciliation and storage checks; ensures IP labeling and release per protocol.
• Routinely reviews ISF and TMF; ensures archiving per local guidelines and regulations.
• Documents activities and supports recruitment, retention and tracking; enters data into tracking systems.
• Manages site-level activities to meet scope, budgets, and timelines; adapts to changing priorities.
• Acts as liaison with study site personnel; ensures training and compliance.
• Prepares for Investigator Meetings; participates in sponsor meetings and training sessions.
• Supports audit readiness and follow-up actions; maintains knowledge of ICH/GCP and SOPs; Real World Late Phase SMA II responsibilities

Skills

GCP/ICH Guidelines knowledge

Excellent communication

Travel up to 75%

Computer skills & new tech

Education

Bachelor's degree or RN in related field

Job description

Syneos Health Careers seeks a CRA II for Italia who will work remotely from home. You will perform site qualification, initiation, monitoring and close-out visits, ensuring regulatory and GCP compliance, while maintaining data integrity and patient safety across sites in Italy.

The role requires travel up to 75% and a Bachelor’s degree or RN in a related field, with strong communication skills and comfort with new technologies.