14 часов назад
Clinical Research Associate I
60 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate I (Clinical Monitoring): Conducting remote and onsite monitoring visits for clinical studies, ensuring data validity, completeness, and subject safety with an accent on ICH-GCP, ISO 14155, and regulatory compliance. Focus on planning site activities, preparing qualification and monitoring visits, and proactively managing trial issues across assigned sites.
Location: United States of America; preferred regions include the West Coast, Upper Midwest, and Northeast near major airports. Travel up to 70–85%.
Annualized minimum base pay: $60,000 USD. The role includes a comprehensive benefits package that may include health insurance, retirement plans, and paid time off.
Company
supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics.
What you will do
- Deliver timely, high-quality monitoring reports for sponsor approval according to Clinical Monitoring Plan timelines.
- Review and collect clinical data at assigned sites, ensuring validity, correctness, completeness, data integrity, and subject safety.
- Conduct remote and onsite qualification, study initiation, interim monitoring, dosing observation, and closeout visits.
- Plan daily monitoring activities and set priorities for each site.
- Monitor studies in accordance with ICH-GCP, ISO 14155, protocols, client requirements, and applicable regulations.
- Work with the Clinical Lead to manage site visits and trial issues proactively.
Requirements
- Undergraduate degree or international equivalent in a clinical, scientific, or health-related field, a licensed healthcare professional qualification, or equivalent work experience.
- Knowledge of ICH-GCP, ISO 14155, FDA guidance documents, EU directives, local and regional regulations, and clinical monitoring procedures.
- Knowledge of clinical and health systems and cultural or professional practices relevant to the monitoring region.
- Ability to multitask, work effectively with technology and people, and adapt to changing priorities.
- Patient-facing or study-coordination experience is preferred.
- Must be based in the United States; travel up to 70–85% is required.
Culture & Benefits
- Flexible working practices designed to support work-life balance.
- Opportunities for professional growth, skills development, and career advancement.
- Comprehensive benefits may include health insurance, retirement plans, and paid time off.
- Equal opportunity employment compliant with federal guidelines.
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