CRA II Multi Sponsor (Remote)

About the role

Syneos Health is hiring a CRA II (also titled Site Management Associate II for Real World Late Phase studies) for a multi-sponsor clinical trial, working remotely. The role covers site qualification, initiation, interim monitoring, site management and close-out, ensuring regulatory, ICH-GCP and protocol compliance. It involves site-level data review, query resolution and audit readiness support.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, on-site or remotely, and escalate serious issues to the project team
• Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
• Review source documents and CRFs, resolve queries and verify electronic data capture compliance
• Check investigational product inventory, dispensing and administration, and ensure proper labelling, import and release
• Review the Investigator Site File and reconcile it with the Trial Master File
• Document activities, support recruitment and retention, and enter observations into tracking systems
• Act as liaison with sites, prepare for investigator meetings and support audit readiness
• Support site identification, chart abstraction and data collection, and suggest potential sites based on local knowledge

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Knowledge of Good Clinical Practice and ICH guidelines and other regulatory requirements
• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills
• Able to travel regularly up to 75%