Home-Based CRA II / Sr CRA I-II (ITA)

About the role

Syneos Health is recruiting a dedicated Clinical Research Associate (CRA) II or Senior CRA I/II for a home-based position in Italy. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, and includes data review, query resolution and site compliance checks. The posting is for a possible future opportunity: interested candidates are added to the talent pipeline.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and protocol compliance
• Evaluate site and site staff performance, escalate serious issues and develop action plans
• Verify informed consent, protect patient confidentiality and assess factors affecting safety and data integrity
• Review source documents and medical records, verify CRF data accuracy and completeness, and resolve queries remotely and on site
• Check site compliance with electronic data capture requirements and, if needed, review investigational product inventory, dispensing and labelling
• Maintain the Investigator Site File and reconcile it with the Trial Master File
• Document activities, support recruitment and retention, and enter data into tracking systems
• Manage site-level activities and communication, prepare for and attend investigator meetings, and guide sites toward audit readiness
• Train and mentor junior CRAs, and may be mentored by an experienced Clinical Operations Lead

Required profile

• At least 2.5 years of experience as a certified CRA (DM 15 November 2011)
• Oncology monitoring and Phase I experience preferred
• Ability to travel regularly up to 75%
• Good computer skills, excellent communication and interpersonal skills, and basic critical thinking

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• Experience with risk-based monitoring is a plus

The employment relationship is governed by the Italian collective labour agreement for tertiary, distribution and services companies, and the annual gross salary range is 45,000 to 69,000 EUR.