15 часов назад
Senior Clinical Research Associate, Neuroscience (Contract)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Associate, Neuroscience (Contract) (Clinical Monitoring): Conducting remote and on-site monitoring visits for neuroscience clinical studies with an accent on data integrity, subject safety, and regulatory compliance. Focus on preparing qualification, initiation, interim, dosing observation, and close-out visits, managing site priorities, and resolving trial issues with the Clinical Lead.
Location: Must be located in California, Nevada, Georgia, or Florida, United States. Monitoring includes remote and on-site visits, with travel of up to 70–85%.
Company
supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics.
What you will do
- Deliver accurate and timely monitoring reports for sponsor approval according to Clinical Monitoring Plan timelines.
- Review clinical data at assigned sites to ensure validity, correctness, completeness, data integrity, and subject safety.
- Plan daily monitoring activities and set priorities for each site.
- Prepare for and conduct qualification, study initiation, interim monitoring, dosing observation, and close-out visits remotely or on site.
- Work with the Clinical Lead to proactively manage site visits and trial issues during the monitoring phase.
Requirements
- Must be located in California, Nevada, Georgia, or Florida.
- Neuroscience clinical monitoring experience is highly prioritized.
- Undergraduate degree or equivalent work experience in a clinical, scientific, or health-related field; licensed healthcare professionals such as registered nurses are also considered.
- Knowledge of ICH-GCP, ISO 14155, FDA guidance documents, EU directives, local and regional regulations, and clinical monitoring procedures.
- Ability to multitask effectively with technology and people in a fast-paced environment with changing priorities.
- Ability to travel up to 70–85%.
Nice to have
- Patient-facing or study-coordinating experience.
- Knowledge of clinical and health systems and cultural or professional practices relevant to monitored sites.
Culture & Benefits
- Full-time contract engagement for six months.
- Flexible working practices intended to support work-life balance.
- Opportunities to develop skills and grow professionally.
- Employee ideas and input influence ways of working.
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