27 дней назад
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
CRA 2 (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, documentation, and data quality. Focus on conducting monitoring visits, resolving study queries, maintaining TMF and ISF records, and coordinating study execution with sites and project teams.
Location: São Paulo, Brazil
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 study scope, GCP, ICH guidelines, and regulatory requirements.
- Manage site recruitment plans, protocol training, communication, project expectations, and issue escalation.
- Track regulatory submissions, approvals, recruitment, enrollment, CRF completion, and data query resolution.
- Evaluate site quality, protocol compliance, and data integrity, escalating issues when required.
- Maintain TMF and verify that Investigator Site Files are complete and compliant with applicable requirements.
- Prepare monitoring visit reports, follow-up letters, action plans, and other study documentation while collaborating with study teams.
Requirements
- Bachelor’s degree in a scientific discipline or healthcare field preferred.
- Excellent written and spoken English.
- Knowledge of clinical research regulations, including GCP and ICH guidelines.
- Good therapeutic and protocol knowledge obtained through company training.
- Strong attention to detail, communication, organization, problem-solving, judgment, and decision-making skills.
- Proficiency with Microsoft Word, Excel, PowerPoint, and applicable laptop, iPhone, and iPad tools.
Culture & Benefits
- Work in an innovative organization focused on improving healthcare and patient outcomes.
- Collaborate with a diverse and talented team.
- Opportunities to develop project management abilities and grow professionally.
- Competitive salary and benefits package.
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