обновлено 11 часов назад
Experienced Clinical Research Associate - Multi Sponsored
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Experienced Clinical Research Associate - Multi Sponsored (Clinical Research): Monitoring clinical trial sites and managing study execution in accordance with protocols, GCP, ICH guidelines, and sponsor requirements with an accent on site management, recruitment tracking, regulatory submissions, and study documentation. Focus on evaluating site quality, resolving data queries, maintaining trial files, and coordinating with study teams across assigned studies.
Location: Dubai, United Arab Emirates
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 according to study protocols, GCP, ICH guidelines, and regulatory requirements.
- Support subject recruitment plans, track enrollment, and manage communication with assigned clinical trial sites.
- Deliver protocol and study-related training and maintain regular communication to address project expectations and issues.
- Evaluate site practices, escalate quality issues, and ensure adherence to protocols and applicable regulations.
- Track regulatory submissions, approvals, CRF completion, data queries, and study progress.
- Maintain TMF and ISF documentation, prepare monitoring reports, follow-up letters, and action plans, and collaborate with study teams.
Requirements
- Bachelor’s degree in a scientific or healthcare discipline, or an equivalent combination of education, training, and experience.
- At least one year of on-site monitoring experience.
- Knowledge of clinical research regulations, including GCP and ICH guidelines.
- Therapeutic and protocol knowledge, organizational and problem-solving skills, and effective time and financial management.
- Fluency in Arabic and a good command of English are required.
- Proficiency with Microsoft Word, Excel, PowerPoint, laptops, and applicable mobile devices.
Culture & Benefits
- Full-time position supporting multi-sponsored clinical studies.
- Collaboration with study team members, sites, managers, clients, and coworkers.
- Work focused on the development and commercialization of medical treatments and improved patient outcomes.
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