9 дней назад
Clinical Research Associate II
74 500 - 197 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate II (Clinical Research): Conducting site selection, initiation, routine monitoring, and closeout visits for clinical trials with an accent on GCP, ICH, regulatory compliance, and investigative-site collaboration. Focus on evaluating site performance, maintaining inspection-ready trial documentation, resolving study queries, and managing risks across therapeutic areas including immunology, dermatology, women's health, respiratory medicine, ophthalmology, and HIV.
Location: Durham, North Carolina, United States; on-site monitoring required
Salary: $74,500–$197,500 annualized base pay
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, routine monitoring, and closeout visits in line with GCP, ICH, and applicable regulations.
- Build relationships with investigative sites and deliver protocol, process, and study-specific training.
- Monitor site activation, patient recruitment, enrollment, data collection, and query resolution.
- Evaluate site performance and compliance, identify risks, and escalate quality concerns.
- Maintain accurate, inspection-ready study documentation, regulatory records, and Trial Master File requirements.
- Prepare monitoring reports, follow-up communications, study documentation, and support site-level recruitment, retention, financial, and administrative activities.
Requirements
- Bachelor's degree.
- At least 1 year of independent on-site monitoring experience in a CRO, biotech, or pharmaceutical company.
- Working knowledge of GCP, ICH, and clinical trial regulations.
- Strong communication, organizational, and problem-solving skills.
- Proficiency with Microsoft Office applications.
Culture & Benefits
- Full-time employment with a global provider serving the life sciences and healthcare industries.
- Health, welfare, and other benefits may be available.
- Incentive plans, bonuses, or other compensation may be offered depending on the position.
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