Senior CRA II, Site Care Partner II

🔥 23 hours ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🪙 Affiliate Manager

🇬🇧 UK Skilled Worker Visa Sponsor

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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 and protocol compliance • Evaluate site and site staff performance and provide site-specific recommendations • Communicate or escalate serious issues and develop action plans • 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 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 and storage/security reviews as required • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities and maintain 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 assigned sites and team members are trained and compliant • Attend Investigator Meetings, sponsor meetings, clinical monitoring/project staff meetings and training sessions • Support audit readiness and audit follow-up actions • Provide supervision, training and mentorship to junior CRAs as assigned • For RWLP: support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsors and affiliates, identify sites, improve processes, develop informed consent forms, support regulatory updates, participate in bid defense, RFP, budgeting, site strategy, CRF design and edit check development

🎯 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 • Moderate level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis • Working knowledge of relevant regulations and company SOPs/processes • UK-based only

🏖️ 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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