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Senior Clinical Research Associate
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Senior Clinical Research Associate (CRA)
Location: Bridgend, Scotland, United Kingdom
Work Arrangement: Site-based monitoring with travel to clinical trial sites
Employment Type: Not specified
Role Overview
An experienced Senior Clinical Research Associate is required to oversee clinical trial site monitoring and management, ensuring studies are conducted in accordance with approved protocols, Good Clinical Practice (GCP), applicable regulations and sponsor requirements.
The role involves site visits, investigator and site-team communication, recruitment oversight, regulatory documentation and the maintenance of clinical trial quality and data integrity.
Key Responsibilities
- Conduct site selection, initiation, monitoring and close-out visits in line with study requirements and GCP.
- Support site recruitment and enrolment targets, tracking progress against project milestones.
- Deliver protocol and study training to site personnel and maintain regular communication with investigators and site teams.
- Assess site compliance, data quality and protocol adherence, escalating quality concerns where necessary.
- Track regulatory submissions, approvals, recruitment, case report form (CRF) completion and data-query resolution.
- Ensure essential documents are maintained in the Trial Master File (TMF) and Investigator Site File (ISF).
- Prepare monitoring visit reports, follow-up letters, action plans and other required study documentation.
- Collaborate with cross-functional study teams to support successful clinical trial delivery.
- Where applicable, contribute to site recruitment planning and clinical trial financial administration.
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Requirements
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- Bachelor's degree in a scientific or healthcare-related discipline, or an equivalent combination of education, training and experience.
- At least one year of on-site clinical monitoring experience.
- Good understanding of clinical research regulations, Good Clinical Practice (GCP) and ICH guidelines.
- Familiarity with clinical trial protocols and therapeutic-area requirements.
- Proficiency in Microsoft Word, Excel and PowerPoint, with confidence using relevant mobile devices and study technology.
- Strong written and verbal communication skills in English.
- Excellent organisation, problem-solving, time management and stakeholder relationship skills.
Important: This position is not eligible for UK visa sponsorship.
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