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CRA I/II

🔥 4 minutes ago

🇨🇳 China – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

Where this job comes from

Posted on Syneos Health's careers page, not through a job board

First seen by Remote Rocketship 4 minutes ago

Logo of Syneos Health

Syneos Health

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, and close-out visits on-site or remotely • Ensure regulatory, ICH-GCP/GPP, protocol, and company SOP/process compliance • Evaluate site and site staff performance and provide recommendations and action plans • Verify informed consent, subject/patient confidentiality, safety, protocol compliance, and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data in case report forms and resolve queries within agreed timelines • Support clinical study data review, capture, and electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing, administration, labeling, and return as applicable • Review and reconcile Investigator Site Files with Trial Master Files and ensure essential-document archiving • Document monitoring activities through letters, trip reports, communication logs, and project documents • Support subject/patient recruitment, retention, and awareness strategies • Track observations, site status, action items, deliverables, budgets, and timelines • Liaise with study site personnel and ensure site/project team training and compliance • Attend investigator, sponsor, global monitoring, and clinical training meetings • Support audit readiness, audit preparation, and follow-up actions • For Real World Late Phase: support sites throughout the study lifecycle, collaborate with sponsor affiliates, medical science liaisons, and local country staff, train junior staff, 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 • Ability to manage required travel of up to 75% on a regular basis • Working knowledge of ICH/GCP Guidelines, applicable guidance, relevant regulations, and company SOPs/processes • Ability to perform clinical monitoring and site management activities on-site or remotely • For Real World Late Phase: knowledge of local requirements for real world late phase study designs • For Real World Late Phase: chart abstraction and data collection capabilities

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Collaboration with colleagues across the world • Remote work (pre-approved)

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