CRA II - Italia - Home Based

In breve

The role of Clinical Research Associate II (CRA II), Italy, Home Based is part of Syneos Health, a global, fully‑integrated life‑sciences services organization that supports drug development and commercialization. Within the Clinical Solutions team, the CRA II helps customers navigate regulatory and operational complexity, contributing to the delivery of clinical studies from site identification through close‑out, either on‑site or remotely. Day‑to‑day, the CRA II will conduct site qualification, initiation, interim monitoring, management and close‑out visits, ensuring compliance with ICH‑GCP, Good Pharmacoepidemiology Practice and protocol requirements. Responsibilities include reviewing source documents, verifying case report form data, managing queries, overseeing investigational product handling, and maintaining accurate Investigator Site Files. The associate will document activities through letters, reports and logs, support recruitment and retention strategies, track observations in study systems, and act as a liaison with site personnel. Participation in investigator meetings, sponsor face‑to‑face sessions, global monitoring meetings and audit‑readiness activities is also required, as is staying current with relevant guidelines, regulations and company SOPs. The position demands a solid foundation in clinical monitoring practices. Candidates must possess a working knowledge of ICH/GCP guidelines (or equivalent local regulations), be experienced in performing site‑level activities such as qualification, initiation, monitoring and close‑out, and be capable of assessing site performance, safety issues and data integrity. The role also requires the ability to adapt quickly to shifting priorities, manage project scope, budgets and timelines, and ensure that all site staff are trained and compliant with applicable requirements. Preferred or nice‑to‑have skills include familiarity with real‑world evidence late‑phase studies and the specific local regulatory requirements that apply to them. The role is home‑based, offering flexibility while still requiring occasional travel for site visits, investigator meetings or sponsor interactions. Syneos Health emphasizes career development, inclusive culture, supportive line management and a total rewards program, providing a collaborative environment for professional growth. What the role asks for: - Knowledge of ICH‑GCP guidelines or equivalent local regulations - Experience performing site qualification, initiation, monitoring and close‑out - Ability to assess site performance, safety and data integrity - Proficiency in source document review and CRF data verification - Capability to manage queries and drive resolution within timelines - Skill in investigational product inventory, reconciliation and security - Ability to adapt quickly to changing priorities and project timelines - Nice‑to‑have: familiarity with local requirements for real‑world late‑phase studies