CRA II

🔥 1 minute ago

🇨🇳 China – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 21 days.
• No salary listed.

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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, and close-out visits on-site or remotely • Evaluate site and site staff performance and provide site-specific recommendations and action plans • Verify informed consent processes, subject/patient confidentiality, safety, protocol compliance, and clinical data integrity • Assess site processes, conduct source document review, verify CRF data, resolve queries, and ensure electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing, administration, labeling, import, and return processes • 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 required project documents • Support subject/patient recruitment, retention, and awareness strategies • Track observations, site status, and action items through resolution • Manage assigned site-level activities and communications to meet project objectives, deliverables, and timelines • Serve as liaison with study-site personnel and ensure site/project team training and compliance • Prepare for and attend investigator and sponsor meetings, global project meetings, and clinical training sessions • Support audit readiness, audit preparation, and follow-up actions • For Real World Late Phase: provide site support throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local 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, relevant regulations, and company SOPs/processes • Must complete assigned training as required • Ability to perform site qualification, initiation, monitoring, management, and close-out activities on-site or remotely • Ability to support clinical study data review, capture, and query resolution • Ability to manage site-level activities, communications, project scope, budgets, and timelines

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations, when appropriate, under the Americans with Disabilities Act

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