18 часов назад
Clinical Research Associate (Client Dedicated)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate (Client Dedicated) (Clinical Research/GCP): Monitoring and managing clinical trial sites in Bangkok to ensure protocol compliance, reliable study data, and regulatory adherence with an accent on site visits, recruitment tracking, and study documentation. Focus on evaluating site quality, resolving data and regulatory issues, and maintaining trial records in accordance with GCP and ICH guidelines.
Location: Bangkok, Thailand
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 the study protocol, GCP, ICH guidelines, and regulatory requirements.
- Track subject recruitment, enrollment, regulatory submissions, approvals, CRF completion, and data query resolution.
- Train assigned sites on study protocols and maintain regular communication to manage project expectations and issues.
- Evaluate site practices, identify and escalate quality issues, and ensure investigator files and trial documents are maintained correctly.
- Prepare monitoring visit reports, follow-up letters, action plans, and other required study documentation for the Trial Master File.
- Collaborate with study teams and support site-level recruitment planning and financial administration where applicable.
Requirements
- Bachelor’s degree in a scientific or healthcare discipline preferred.
- Prior on-site monitoring experience, or an equivalent combination of education, training, and experience.
- Knowledge of clinical research regulations, including Good Clinical Practice and International Conference on Harmonization guidelines.
- Good therapeutic and protocol knowledge, along with proficiency in Microsoft Word, Excel, and PowerPoint.
- Good command of English, strong communication and organizational skills, and the ability to solve problems and manage time effectively.
- Ability to build effective working relationships with coworkers, managers, clients, and clinical research sites.
Culture & Benefits
- Full-time employment within Thailand’s Clinical Operations team.
- Work focused on clinical research execution and the development of medical treatments.
- Collaboration with study teams, clinical sites, sponsors, and healthcare stakeholders.
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