3 дня назад
Senior Clinical Research Associate I (SCRA I)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Associate I (SCRA I) (Clinical Trials): Managing and monitoring investigator sites from initiation through database lock while supporting site activation, patient safety, and trial quality with an accent on ICH/GCP compliance, regulatory interactions, and complex site operations. Focus on resolving investigator-site issues, developing CAPAs, mentoring CRAs, overseeing investigational products and safety data, and collaborating across clinical research functions.
Location: Remote in Argentina; significant travel of 60–80% within the assigned area, with occasional international and weekend travel.
Company
develops medicines and conducts global clinical research across multiple therapeutic areas.
What you will do
- Independently manage and monitor investigator sites from initiation through database lock.
- Support feasibility, site selection, Pre-Trial Assessments, activation checklists, informed consent finalization, and Site Initiation Visits.
- Mentor and train Clinical Research Associates and serve as a subject matter expert for CRA-related processes.
- Resolve complex site issues, implement CAPAs, manage quality-event remediation, and support regulatory inspections and sponsor interactions.
- Monitor adverse events and serious adverse events, oversee investigational product handling, support database release, and conduct remote e-diary assessments.
- Collaborate with Site Care Partners, Country SOMs, clinicians, recruitment specialists, and clinical data scientists on enrollment and protocol inquiries.
Requirements
- Bachelor’s degree in Life Sciences or a professional degree in nursing, pharmacy, medicine, or an equivalent field.
- At least 3 years of relevant clinical research site-monitoring experience; oncology experience is preferred.
- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA requirements, and local regulations.
- Prior global clinical trial experience and fluency in English and the native language of Argentina.
- Ability to work in a matrix environment, influence stakeholders, lead through others, interpret complex data, and support risk management.
- Valid driver’s license and passport required; willingness to travel 60–80% is required.
Nice to have
- At least 2 years of oncology experience.
- Therapeutic experience in vaccines, internal medicine, or infectious diseases.
Culture & Benefits
- Collaborative work across clinical operations, safety, data science, recruitment, and site-care functions.
- Opportunities to mentor CRAs and contribute to regional working groups and process-improvement initiatives.
- Exposure to global clinical trials and external investigator and regulatory stakeholders.
- Remote work arrangement with substantial regional travel.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
8 дней назад
Senior Clinical Research Associate (Clinical Trials)
7 дней назад
Study Coordinator (Clinical Research)
7 дней назад
Medical Scientific Affairs Sr. Specialist / Specialist (Medical Devices)
8 дней назад
Regulatory & Start Up Specialist 2, cFSP
9 дней назад
Clinical Trial Manager (Class III Medical Devices)
117 000 - 156 750$
4 дня назад