Senior Clinical Research Associate II – Remote/Onsite Monitoring

Syneos Health, Inc.; Milano; On-site; EUR 57,000 - 69,000; Full time

Job summary

Syneos Health is seeking a Senior CRA II for Italy to manage site qualification, initiation, monitoring, and close-out visits, on-site or remotely as required. You will ensure regulatory, ICH-GCP and GPP protocol compliance, and communicate issues to the project team.

The role requires in-depth knowledge of trial processes, data integrity, and site management plans. You may train junior CRAs, support recruitment and retention, and collaborate with sponsor staff to meet timelines and budgets.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent.
• Knowledge of GCP/ICH guidelines and regulatory requirements.
• Excellent written and verbal communication, and computer literacy.
• Ability to use new technologies and present effectively.

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or GPP and protocol compliance.
• Verifies informed consent processes and protects subject confidentiality; assesses safety and data integrity factors.
• Monitors data via source document review and CRF checks; supports query resolution to closure within timelines.
• Manages IP inventory, reconciliation, and storage per protocol; ensures proper labeling, import/export and release/return.
• Maintains ISF and TMF alignment; archives documents per guidelines and communicates with sites.
• Prepares for investigator meetings, trains site staff, and contributes to audit readiness and follow-up actions.

Skills

GCP/ICH knowledge

Computer skills

Communication skills

Education

Bachelor’s degree or RN in a related field

Job description

Syneos Health is seeking a Senior CRA II for Italy to manage site qualification, initiation, monitoring, and close-out visits, on-site or remotely as required. You will ensure regulatory, ICH-GCP and GPP protocol compliance, and communicate issues to the project team.

The role requires in-depth knowledge of trial processes, data integrity, and site management plans. You may train junior CRAs, support recruitment and retention, and collaborate with sponsor staff to meet timelines and budgets.