Senior Clinical Research Associate (CRA)

About the role

Syneos Health is hiring a Senior CRA for a Real World Late Phase (RWLP) study in Mexico. The role covers site qualification, initiation, interim monitoring, site management and close-out, with on-site or remote visits, and may involve mentoring junior CRAs and acting as liaison with site personnel.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and protocol compliance
• Evaluate site 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 medical records, verify CRF data accuracy and completeness, and resolve queries
• Check site compliance with electronic data capture requirements
• Review 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
• Manage site-level activities and communication, and prepare for and attend investigator and sponsor meetings
• Support audit readiness, train and mentor junior CRAs, and sign off visits as assigned
• For RWLP: site support throughout the study lifecycle, chart abstraction, data collection, country-level informed consent forms, and collaboration with the RWLP regulatory team

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Good computer skills and ability to embrace new technologies
• Ability to manage travel of up to 75% regularly
• Excellent communication, presentation and interpersonal skills

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• Basic critical thinking skills