3 дня назад
Clinical Research Associate, South West England
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate, South West England (Clinical Research/GCP): Conducting site monitoring and managing interventional clinical studies across start-up, enrolment, maintenance, and close-out with an accent on GCP compliance, recruitment tracking, and study documentation. Focus on evaluating site quality, resolving regulatory and data issues, maintaining TMF and ISF records, and coordinating study execution with sites and project teams.
Location: Bath, United Kingdom; work across South West England sites. Full UK right to work is required. This position is not eligible for visa sponsorship.
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Perform site selection, initiation, monitoring, and close-out visits for interventional clinical studies.
- Drive and track subject recruitment plans and manage ongoing site expectations and issues.
- Deliver protocol and study training and maintain regular communication with assigned sites.
- Evaluate site practices for protocol, GCP, ICH, and regulatory compliance, escalating quality issues when needed.
- Track regulatory submissions, approvals, recruitment, enrolment, CRF completion, and data query resolution.
- Maintain TMF and ISF documentation, visit reports, follow-up letters, and site action plans while supporting study execution.
Requirements
- At least 2 years of independent on-site monitoring experience in interventional studies.
- Experience across study start-up, enrolment, maintenance, and close-out.
- Degree in a scientific or healthcare discipline, or equivalent industry experience.
- Strong knowledge of Good Clinical Practice and International Conference on Harmonization guidelines.
- Digital literacy, including confidence using AI tools professionally.
- Full UK right to work required; visa sponsorship is not available.
Culture & Benefits
- Career development opportunities and access to the AI-powered Career Connections talent marketplace.
- Mentorship opportunities through Employee Resource Groups.
- Flexible working to support work-life balance and professional success.
- Physical, mental, and financial well-being support.
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