CRA II – Ophthalmology Experience Required

🕒 March 19

🇧🇷 Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 45%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Perform site qualification, site initiation, interim monitoring, site management activities and close-out visits on-site or remotely • Evaluate site and site staff performance and provide recommendations regarding site-specific actions • Communicate and escalate serious issues to the project team and develop action plans • Verify informed consent processes, subject/patient confidentiality, safety, and clinical data integrity • Conduct source document review and verify clinical data accuracy and completeness • Resolve queries remotely and on site and guide site staff toward resolution • Verify site compliance with electronic data capture requirements • Manage investigational product inventory, reconciliation, storage, dispensing, administration, labeling, importation and return when applicable • Review and reconcile Investigator Site Files and Trial Master Files • Document monitoring activities and maintain tracking systems • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities and communications to meet project objectives, deliverables and timelines • Serve as primary liaison with study site personnel and ensure site team training and compliance • Attend investigator, sponsor, global clinical monitoring and training meetings • Support audit readiness and audit follow-up actions • For real-world late-phase studies, provide site support throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff when requested, identify out-of-scope activities, and suggest potential sites

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Ophthalmology experience is required • Ability to manage required travel of up to 75% on a regular basis • Working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes • Ability to complete assigned training as required

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Opportunities to collaborate with colleagues across the world

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