6 дней назад
Senior Clinical Research Associate
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Associate (Clinical Trials): Managing site monitoring and clinical trial execution across investigative sites with an accent on GCP/ICH compliance, recruitment tracking, and study documentation. Focus on conducting monitoring visits, evaluating site quality, resolving regulatory and data issues, and maintaining accurate trial records.
Location: Reading, Berkshire, United Kingdom
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Conduct site selection, initiation, monitoring, and close-out visits in line with contracted scope, GCP, ICH guidelines, and regulatory requirements.
- Support subject recruitment plans and track recruitment, enrollment, regulatory submissions, approvals, and study progress.
- Train assigned sites on study protocols and maintain regular communication to manage expectations and resolve issues.
- Evaluate site practices, protocol adherence, data quality, and regulatory compliance, escalating quality issues when needed.
- Maintain Trial Master File and Investigator's Site File documentation, visit reports, follow-up letters, and action plans.
- Collaborate with study team members to support project execution and study start-up activities.
Requirements
- At least 18 months of independent on-site monitoring experience.
- Experience managing multiple clinical trial protocols across diverse investigative sites.
- In-depth knowledge of Good Clinical Practice and International Conference on Harmonization guidelines.
- Degree in life sciences or equivalent industry experience.
- Flexibility to travel to clinical sites.
- This role is not eligible for UK visa sponsorship.
Culture & Benefits
- Access to world-class training and professional development.
- Career development opportunities within the organization.
- Exposure to cutting-edge medicines and innovative clinical development programs.
- Access to significant clinical data pools supporting site selection, recruitment, and study performance.
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