12 дней назад
Sr CRA 3 (Clinical Research)
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
Sr CRA 3 (Clinical Research) (Clinical Trials): Independently managing and monitoring clinical trial sites in Argentina across qualification, initiation, routine monitoring, and closeout visits with an accent on GCP, ICH, regulatory compliance, and site performance. Focus on reviewing source documentation, resolving data queries, maintaining essential documents, and identifying quality issues across multiple study phases.
Location: Buenos Aires, Argentina
Company
IQVIA Biotech is a full-service contract research organization serving biotech sponsors with clinical research and healthcare intelligence services.
What you will do
- Manage and monitor clinical trial sites independently across qualification, initiation, routine monitoring, and closeout visits.
- Ensure studies comply with protocols, Good Clinical Practice, ICH guidelines, regulatory requirements, and sponsor expectations.
- Support patient recruitment and retention while providing protocol and study-related training to investigative sites.
- Oversee site performance, study milestones, source documentation, data query resolution, and essential regulatory documents.
- Document monitoring activities through timely and accurate reports and collaborate with cross-functional study teams.
- Mentor junior clinical research associates through co-monitoring and training activities.
Requirements
- Bachelor’s degree in a scientific, healthcare, or related discipline, or an equivalent combination of education and experience.
- At least 4 years of on-site clinical monitoring experience.
- Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial processes.
- Experience conducting monitoring visits across multiple phases of clinical research.
- Excellent organizational, communication, and problem-solving skills with the ability to manage multiple priorities.
- Proficiency with Microsoft Office applications and clinical trial systems.
Nice to have
- Strong therapeutic-area knowledge and protocol management experience.
- Experience building productive relationships with investigative sites, sponsors, and internal study teams.
- Experience mentoring or supporting junior clinical research professionals.
Culture & Benefits
- Full-time position within the Clinical Monitoring team in Argentina.
- Work alongside investigative sites, sponsors, and cross-functional clinical research teams.
- Contribute to the development of innovative therapies and improved patient outcomes.
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