Senior Clinical Research Associate, UK Monitoring Experience

🔥 1 hour 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 provide recommendations and action plans • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review and medical record review • Verify clinical data entered in case report forms and resolve queries within agreed timelines • Use hardware and software to support clinical study data review and capture • Verify compliance with electronic data capture requirements • Perform investigational product inventory, reconciliation, storage, dispensing and administration checks as applicable • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through letters, trip reports, communication logs and project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, status and action items to resolution • Manage site-level activities and communications to meet project objectives, deliverables and timelines • Liaise with project site personnel and Central Monitoring Associates • Ensure assigned sites and project-specific site team members are trained and compliant • Prepare for and attend Investigator Meetings, sponsor meetings, clinical monitoring/project staff meetings and training sessions • Support audit readiness, audit preparation and follow-up actions • Provide training or mentorship to junior CRAs and perform training/sign-off visits as assigned • For RWLP: support sites throughout the study lifecycle, perform chart abstraction and data collection, develop country-level informed consent forms, identify operational efficiencies, participate in bid defense meetings and collaborate with sponsors, affiliates, regulatory teams, medical science liaisons and local country staff

🎯 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 • Basic level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis • UK monitoring experience • Working knowledge of ICH/GCP Guidelines, Good Pharmacoepidemiology Practice (GPP), relevant regulations, and company SOPs/processes • Ability to perform clinical monitoring activities on-site or remotely • Ability to manage site-level activities, communications, project objectives, deliverables and timelines • Ability to quickly adapt to changing priorities

🏖️ 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, to assist employees or applicants with disabilities