обновлено 3 дня назад
Clinical Research Associate - Sponsor Dedicated
74 500 - 197 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate - Sponsor Dedicated (Clinical Research): Performing site monitoring and management for clinical studies, ensuring protocol compliance, data quality, and regulatory adherence with an accent on GCP/ICH requirements, recruitment tracking, and study documentation. Focus on conducting monitoring visits, resolving data queries, maintaining trial files, and coordinating study execution with sites and project teams.
Location: Overland Park, Kansas, United States of America
Salary: $74,500–$197,500 annual 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, monitoring, and close-out visits in line with the study protocol, GCP, ICH guidelines, and regulatory requirements.
- Support site recruitment plans, track enrollment, and manage ongoing communication with assigned sites.
- Deliver protocol and study-related training and address site expectations and issues.
- Evaluate site quality and protocol adherence, escalating issues when required.
- Track regulatory submissions, approvals, CRF completion, data queries, and query resolution.
- Maintain TMF and ISF documentation, visit reports, follow-up letters, action plans, and other study records.
Requirements
- Bachelor’s degree in a scientific or healthcare discipline preferred; equivalent education, training, and experience may be accepted.
- CRA training or prior monitoring experience may be required by the assigned organization.
- Basic knowledge of clinical research regulations, GCP, and ICH guidelines.
- Knowledge of therapeutic areas and clinical trial protocols.
- Proficiency with Microsoft Word, Excel, PowerPoint, and relevant laptop, iPhone, and iPad applications.
- Good command of English, strong communication, organization, problem-solving, time management, and relationship-building skills.
Culture & Benefits
- Full-time employment with potential health and welfare benefits.
- Potential incentive plans, bonuses, and other compensation may be available depending on the position.
- Work involves collaboration with sites, study teams, managers, coworkers, and clients.
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