Single Sponsor CRA I/II – UK Monitoring Experience

🔥 7 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 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 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 • Verify informed consent, subject safety, confidentiality and clinical data integrity • Conduct source document review and verify case report form data accuracy and completeness • Resolve queries remotely and on site and guide site staff • Verify electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing and administration as applicable • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through required letters, reports and communication logs • Support subject/patient recruitment, retention and awareness strategies • Track observations, site status and action items to resolution • Manage site-level activities and communications to meet project objectives, deliverables and timelines • Act as liaison with study site personnel and ensure site/project team training and compliance • Attend investigator, sponsor, global monitoring and clinical training meetings • Support audit readiness and audit follow-up actions • For real-world late phase studies, support sites 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 based on local knowledge

🎯 Requirements

• Must have UK monitoring experience • 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

🏖️ Benefits

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

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