Senior CRAII/Sr CRA - Multi-sponsor

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

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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 • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and provide recommendations and action plans • Escalate serious issues to the project team • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data in case report forms and drive query resolution • Use hardware and software for clinical study data review and capture • Verify electronic data capture compliance • Perform investigational product inventory, reconciliation and storage/security reviews when required • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through required project documents and tracking systems • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities and communications to meet project objectives, deliverables and timelines • Act as primary liaison with study site personnel or collaborate with the Central Monitoring Associate • Ensure assigned sites and project-specific site team members are trained and compliant • Attend investigator, sponsor, global monitoring and clinical training meetings • Support audit readiness and audit follow-up actions • Maintain knowledge of applicable guidelines, regulations and company SOPs and complete required training

🎯 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 • Previous monitoring experience in the UK • 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

🏖️ 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

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