12 дней назад
FSP CRA 1 & CRA 2
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
FSP CRA 1 & CRA 2 (Clinical Research): Monitoring clinical trial sites in Lima, Peru and managing study conduct, recruitment, regulatory submissions, and trial documentation with an accent on GCP/ICH compliance and site performance. Focus on conducting monitoring visits, resolving data queries, maintaining TMF and ISF records, and coordinating study execution with sites and project teams.
Location: Lima, Peru; availability to travel required
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 according to the study protocol, GCP, ICH guidelines, and regulatory requirements.
- Support subject recruitment plans and track recruitment, enrollment, regulatory submissions, approvals, CRF completion, and data query resolution.
- Train assigned sites on study protocols and maintain regular communication to manage expectations, issues, and project progress.
- Evaluate site quality and protocol compliance, escalate issues, and document monitoring findings and action plans.
- Maintain Trial Master File and Investigator Site File documentation and prepare visit reports, follow-up letters, and other study records.
- Collaborate with study teams and, where applicable, support site financial management and invoice collection.
Requirements
- Bachelor’s degree in a scientific or healthcare discipline preferred.
- 6 months to 2 years of on-site monitoring experience, including monitoring visits and monitoring reports.
- Must be living in Lima, Peru and available to travel.
- Good command of written and spoken English required.
- Knowledge of clinical research regulations, GCP, and ICH guidelines.
- Proficiency with Microsoft Word, Excel, PowerPoint, and relevant laptop, iPhone, and iPad tools.
Culture & Benefits
- Full-time employment in a global clinical research and healthcare intelligence organization.
- Work involves collaboration with clinical sites, study teams, managers, coworkers, and clients.
- Responsibilities include organizational, problem-solving, time management, and financial management activities.
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