Senior CRAI - Real World Late Phase

About the role

Syneos Health is hiring a Senior CRAI (Clinical Research Associate I) for Real World Late Phase (RWLP) studies. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, and includes mentoring junior CRA staff. The business card title used for RWLP is Senior Site Management Associate I.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or GPP and protocol compliance
• Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
• Review source documents and medical records, verify CRF data accuracy and completeness, and resolve queries within agreed timelines
• Check site compliance with electronic data capture requirements
• Review the Investigator Site File, reconcile it with the Trial Master File and ensure proper archiving
• Support subject recruitment, retention and awareness, and enter observations and action items into tracking systems
• Manage site-level activities and communication to meet project objectives and timelines
• Act as liaison with site personnel, prepare for and attend investigator and sponsor meetings, and support audit readiness
• Mentor and train junior CRA staff, and sign off visits for them when assigned
• For RWLP: site support throughout the study lifecycle, chart abstraction and data collection, country-level informed consent forms, and collaboration with the RWLP Regulatory team
• Identify potential sites, propose process improvements, and take part in bid defense meetings

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
• Ability to manage regular travel of up to 75%

Required skills

• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills
• Basic critical thinking skills