5 дней назад
Clinical Research Associate
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
Clinical Research Associate (Clinical Research): Monitoring and managing clinical trial sites in accordance with study protocols, GCP/ICH guidelines, regulatory requirements, and sponsor expectations with an accent on site oversight, recruitment tracking, and study documentation. Focus on evaluating site quality, resolving data queries, maintaining TMF and ISF records, and coordinating study execution with clinical teams.
Location: Sofia, Bulgaria
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 line with study protocols, 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 communication to manage expectations and resolve issues.
- Evaluate site practices, escalate quality issues, and verify adherence to protocols and applicable regulations.
- Maintain TMF and ISF documentation, prepare monitoring visit reports, follow-up letters, and action plans.
- Collaborate with study team members and support site financial management or recruitment planning where applicable.
Requirements
- Native Bulgarian language and English proficiency required.
- Bachelor’s degree in a scientific or healthcare discipline preferred; equivalent education, training, and experience may be accepted.
- At least one year of on-site monitoring experience required.
- Knowledge of clinical research regulations, including GCP and ICH guidelines.
- Good therapeutic and protocol knowledge, organizational and problem-solving skills, and effective time and financial management.
- Proficiency with Microsoft Word, Excel, PowerPoint, and applicable laptop, iPhone, and iPad tools.
Culture & Benefits
- Work within a global clinical research and healthcare intelligence organization.
- Collaborate with sites, study teams, managers, coworkers, and clients.
- Support the development and commercialization of medical treatments and improved patient outcomes.
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