Remote CRA II: Clinical Monitoring & Site Management

Syneos Health, Inc.; Milano; Remote; EUR 45.000 - 69.000; Vollzeit

Zusammenfassung

Syneos Health, Inc. is seeking a sponsor dedicated CRA II / Sr CRA I/II for home-based work in Italy. The role focuses on monitoring clinical sites, ensuring GCP compliance, and coordinating with site staff remotely or on-site. Strong communication and regulatory knowledge are essential.

The position supports site qualification, initiation, monitoring, and close-out visits, with potential travel and collaboration across multicentre trials in oncology. Experience as a CRA is required.

Qualifikationen

• At least 2.5 yrs of experience as Certified CRA according to DM 15 Nov 2011

Aufgaben

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (onsite or remotely) ensuring regulatory, ICH-GCP and/or GPP compliance.
• Verifies informed consent process and protects confidentiality; assesses safety and data integrity at investigator sites.
• Conducts source data review, CRF data accuracy, and query resolution; uses systems to track observations and actions.
• Manages IP inventory, reconciliation, and storage; ensures proper labeling and release per protocol.
• Routinely reviews ISF for accuracy and archiving; supports recruitment, retention and awareness strategies.
• Understands scope, budgets, and timelines; adapts to changing priorities to meet targets.
• May liaison with project site personnel and lead/ mentor junior CRAs; may participate in trainings.

Kenntnisse

CRA experience

Oncology monitoring

Remote monitoring

Jobbeschreibung

Syneos Health, Inc. is seeking a sponsor dedicated CRA II / Sr CRA I/II for home-based work in Italy. The role focuses on monitoring clinical sites, ensuring GCP compliance, and coordinating with site staff remotely or on-site. Strong communication and regulatory knowledge are essential.

The position supports site qualification, initiation, monitoring, and close-out visits, with potential travel and collaboration across multicentre trials in oncology. Experience as a CRA is required.