4 дня назад
Sr. CRA 1 - Single Sponsor Dedicated (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr. CRA 1 - Single Sponsor Dedicated (Clinical Research): Conducting site monitoring and management for sponsor-dedicated clinical studies in accordance with protocols, GCP, ICH guidelines, and regulatory requirements with an accent on recruitment tracking, site quality, and trial documentation. Focus on monitoring study progress, resolving data queries, maintaining TMF and ISF records, and escalating compliance issues.
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
- Perform site selection, initiation, monitoring, and close-out visits in accordance with the study protocol, Good Clinical Practice, and contracted scope.
- Support subject recruitment plans and track recruitment, enrollment, regulatory submissions, approvals, and study progress.
- Train assigned sites on protocols and study procedures while maintaining regular communication and managing project issues.
- Evaluate site quality, protocol compliance, and adherence to applicable clinical research regulations, escalating issues when necessary.
- Maintain TMF and ISF documentation, prepare monitoring visit reports, follow-up letters, and action plans.
- Collaborate with study teams and support site financial management and invoice retrieval where applicable.
Requirements
- Bachelor's degree in a scientific or healthcare discipline preferred.
- At least 2 years of on-site monitoring experience.
- Knowledge of clinical research regulations, including GCP and ICH guidelines.
- Therapeutic and protocol knowledge, organizational skills, and effective problem-solving and time-management abilities.
- Good command of English and strong written and verbal communication skills.
- This role is not eligible for UK visa sponsorship; candidates must already have the right to work in the United Kingdom.
Culture & Benefits
- Full-time employment in a sponsor-dedicated clinical research function.
- Collaboration with study team members, sites, managers, coworkers, and clients.
- Use of Microsoft Word, Excel, PowerPoint, and mobile devices to support study execution.
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