25 дней назад
Senior CRA1 (MultiSponsor, Czechia)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior CRA1 (MultiSponsor, Czechia) (Clinical Research): Performing monitoring and site management across clinical trial protocols and therapeutic areas with an accent on GCP/ICH compliance, site recruitment, and study documentation. Focus on conducting site visits, tracking regulatory submissions and enrollment, resolving data queries, and maintaining trial and investigator files.
Location: Prague, Czech Republic
Company
IQVIA 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 across assigned protocols, sites, and therapeutic areas.
- Support site recruitment plans and track recruitment, enrollment, regulatory submissions, approvals, and study progress.
- Train assigned sites on protocols and maintain regular communication to manage study expectations and issues.
- Evaluate site quality and compliance with Good Clinical Practice, ICH guidelines, and applicable regulations.
- Maintain Trial Master File and Investigator Site File documentation, visit reports, follow-up letters, and action plans.
- Mentor clinical staff through co-monitoring and training visits and collaborate with study team members.
Requirements
- Bachelor’s degree in a scientific discipline or healthcare, or an equivalent combination of education, training, and experience.
- At least 3 years of on-site monitoring experience.
- In-depth knowledge of clinical research regulatory requirements, Good Clinical Practice, and ICH guidelines.
- Strong therapeutic and protocol knowledge, organizational, problem-solving, time-management, and financial-management skills.
- Proficiency with Microsoft Word, Excel, PowerPoint, and relevant laptop, iPhone, and iPad use.
- Good command of English is required.
Culture & Benefits
- Full-time employment in the MultiSponsor clinical research team.
- Work across varied protocols, sites, and therapeutic areas.
- Collaboration with study teams, clinical staff, sites, managers, and clients.
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