Single Sponsor Senior CRA II - UK South West Region

Syneos Health · GBR-Remote · remote Syneos Health is seeking a Single Sponsor Senior CRA II to work in the UK South West Region. The successful candidate will have solid UK monitoring experience. The role involves performing site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance. The CRA will assess site processes, verify informed consent, and monitor subject/patient safety and clinical data integrity. Responsibilities: Perform site qualification, site initiation, interim monitoring, site management, and close-out visits Evaluate overall performance of site and site staff, providing recommendations for site-specific actions Verify process of obtaining informed consent and document confidentiality of subjects/patients Assess factors affecting subject/patient safety and clinical data integrity Conduct Source Document Review and verify clinical data entry in case report forms Apply query resolution techniques and provide guidance to site staff Utilize hardware and software to support clinical study data review and capture Verify site compliance with electronic data capture requirements Perform investigational product inventory, reconciliation, and review storage and security Routinely review Investigator Site File and Trial Master File Document activities via confirmation letters, follow-up letters, trip reports, and communication logs Support subject/patient recruitment, retention, and awareness strategies Enter data into tracking systems to track observations and action items Understand project scope, budgets, and timelines, managing site-level activities and communication Act as primary liaison with study site personnel and Central Monitoring Associate Prepare for and attend Investigator Meetings and sponsor face-to-face meetings Provide guidance on audit readiness standards and support preparation for audits May provide direct supervision, training, and mentorship to junior CRAs Qualifications: 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 applicable regulatory requirements Good computer skills and ability to adapt to new technologies Excellent communication, presentation, and interpersonal skills Ability to manage required travel of up to 75% on a regular basis