Senior Clinical Research Associate I (Remote)

About the role

Syneos Health is hiring a Senior Clinical Research Associate I (CRA I) for a remote position. The role covers site qualification, initiation, interim monitoring, site management and close-out visits, performed on-site or remotely, ensuring regulatory, ICH-GCP and protocol compliance. The posting also notes that for Real World Late Phase studies the title used is Site Management Associate II.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, evaluating site performance and escalating serious issues
• Verify informed consent and protect subject confidentiality; 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 and support recruitment, retention and awareness strategies
• Manage site-level activities, communicate with sites and prepare for audits
• Attend investigator meetings, project meetings and clinical training, and suggest potential sites

Required profile

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