6 дней назад
Clinical Research Associate, Sponsor Dedicated (Clinical Research)
71 900 - 189 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Clinical Research Associate, Sponsor Dedicated (Clinical Research): Performing clinical trial site monitoring and management in compliance with study protocols, GCP, ICH guidelines, and sponsor requirements with an accent on recruitment tracking, regulatory submissions, and study documentation. Focus on evaluating site quality, resolving data queries, maintaining trial files, and managing monitoring findings across study phases.
Location: Carlsbad, California, United States; candidates must reside in the same country as the job location.
Salary: $71,900–$189,000 annualized base pay, with potential additional incentives and benefits.
Company
IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Conduct site selection, initiation, monitoring, and close-out visits in line with the study scope, GCP, ICH guidelines, and applicable regulations.
- Coordinate subject recruitment plans, track enrollment, and support study start-up activities.
- Train assigned sites on study protocols and maintain communication regarding project expectations and issues.
- Assess site practices, escalate quality issues, and document monitoring findings and action plans.
- Track regulatory submissions, approvals, case report forms, data queries, and trial documentation for the TMF and ISF.
- Collaborate with study teams and support site financial management and invoice retrieval when applicable.
Requirements
- At least 1 year of independent on-site monitoring experience as a Clinical Research Associate.
- Bachelor’s degree in a scientific or healthcare discipline preferred; equivalent education, training, and experience may be accepted.
- Knowledge of clinical research regulations, including GCP and ICH guidelines, plus relevant therapeutic and protocol knowledge.
- Good command of English and strong written and verbal communication skills.
- Proficiency with Microsoft Word, Excel, PowerPoint, laptops, and applicable mobile devices.
- Strong organizational, problem-solving, time-management, financial-management, and relationship-building skills.
Culture & Benefits
- Full-time employment with health and welfare benefits.
- Potential incentive plans, bonuses, and other compensation in addition to base pay.
- Work focused on clinical research and the development of medical treatments that improve patient outcomes.
- Equal opportunity employment environment.
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