CRA II (Multi-Sponsor) - Mexico, Home Based

About the role

Syneos Health is hiring a CRA II (multi-sponsor) for a home-based position in Mexico. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, in line with regulatory, ICH-GCP and Good Pharmacoepidemiology Practice (GPP) requirements.

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 and administration, and ensure proper labelling, import and return
• Review the Investigator Site File, reconcile it with the Trial Master File and document site activities
• Support recruitment and retention, enter tracking data and prepare sites for audits
• Attend investigator meetings, project meetings and clinical training, and suggest potential sites
• For Real World Late Phase studies: chart abstraction, data collection and knowledge of local study design requirements
• Manage site-level activities within budget and timeline, and travel regularly up to 75%

Required profile

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

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• ICH-GCP guidelines and relevant regulations