Senior CRA II – Single Sponsor, UK Monitoring

🔥 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 and close-out visits on-site or remotely • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and recommend site-specific actions • Escalate serious issues and develop action plans • Verify informed consent, subject/patient confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data in case report forms against source documents and medical records • Resolve queries remotely and on site within agreed timelines • Use hardware and software for clinical study data review and capture • Verify electronic data capture compliance • Perform investigational product inventory, reconciliation, storage, dispensing and administration reviews as required • Review and reconcile Investigator Site Files with Trial Master Files • Document monitoring activities in required project documentation 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 liaison with study site personnel and ensure site team training and compliance • Prepare for and attend investigator and sponsor meetings • Participate in or lead clinical monitoring/project staff meetings and attend clinical training • Support audit readiness and audit follow-up actions • Provide supervision, training and mentorship to junior CRAs • Perform training and sign-off visits for junior CRA staff • May participate in business development proposals and defense meetings

🎯 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 • Must demonstrate good computer skills and be able to embrace new technologies • Excellent communication, presentation and interpersonal skills • Moderate level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis • Must have solid UK monitoring experience

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture • Diversity, inclusion and belonging initiatives

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