Clinical Research Associate II (Remote)

About the role

Syneos Health is hiring a Clinical Research Associate II (CRA II) for a remote position. The role covers site qualification, initiation, interim monitoring, site management and close-out visits, performed on-site or remotely, in line with regulatory, ICH-GCP and Good Pharmacoepidemiology Practice (GPP) requirements. For Real World Late Phase studies, the business card title is Site Management Associate II.

Key responsibilities

• Evaluate site and site staff performance, escalate serious issues and develop action plans
• Verify informed consent, protect subject confidentiality and assess safety and data integrity risks
• Review source documents and CRFs, resolve queries and verify electronic data capture compliance
• Check investigational product inventory, dispensing, labelling and release, and reconcile the Investigator Site File with the Trial Master File
• Document site activities, support recruitment and retention, and prepare sites for audits
• Attend investigator meetings, project meetings and clinical training, and advise on audit readiness
• For Real World Late Phase: site support throughout the study lifecycle, chart abstraction, data collection and collaboration with sponsors, medical science liaisons and local country staff
• Identify out-of-scope activities, suggest potential sites and possibly train junior staff

Required profile

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