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

About the role

Syneos Health is hiring a CRA II (multi-sponsor) for opthalmology studies in Brazil, working from home. The role covers site qualification, initiation, interim monitoring, site management and close-out, with regulatory, ICH-GCP and protocol compliance. The position is home-based and requires opthalmology experience.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, on-site or remotely, and escalate serious issues to the project team
• Verify informed consent, protect subject confidentiality and 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 return
• Review the Investigator Site File and reconcile it with the Trial Master File
• Support subject recruitment and retention, enter tracking data and prepare for audits
• Attend investigator and sponsor meetings, train junior staff and suggest potential sites
• For Real World Late Phase studies: chart abstraction, data collection and knowledge of local study design requirements

Required profile

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

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• Working knowledge of ICH/GCP guidelines, regulations and company SOPs