6 дней назад
Clinical Research Associate - Sponsor Dedicated (Clinical Research)
71 900 - 189 000$
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 with an accent on GCP/ICH compliance, recruitment tracking, protocol training, and study documentation. Focus on evaluating site practices, resolving data and regulatory issues, maintaining TMF/ISF records, and coordinating study execution with sites and project teams.
Location: Overland Park, Kansas, United States
Salary: $71,900–$189,000 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 according to the study scope and regulatory requirements.
- Manage site recruitment plans, enrollment tracking, regulatory submissions, approvals, and case report form completion.
- Train assigned sites on study protocols and maintain communication to manage expectations and resolve issues.
- Evaluate site practices for protocol, GCP, ICH, and applicable regulatory compliance, escalating quality issues when needed.
- Maintain Trial Master File and Investigator’s Site File documentation and prepare monitoring reports, follow-up letters, and action plans.
- Collaborate with study teams and support site financial management or study start-up activities when applicable.
Requirements
- Bachelor’s degree in a scientific or healthcare discipline preferred; equivalent education, training, and experience may be accepted.
- Basic knowledge of Good Clinical Practice and International Conference on Harmonization guidelines.
- CRA training or prior monitoring experience may be required by the relevant organization.
- Good therapeutic and protocol knowledge, with proficiency in Microsoft Word, Excel, and PowerPoint.
- Good command of English, strong written and verbal communication, organizational, problem-solving, time-management, and financial-management skills.
- Ability to build effective working relationships with coworkers, managers, clients, and clinical study sites.
Culture & Benefits
- Full-time employment with potential incentive plans, bonuses, and additional compensation depending on the position.
- Health and welfare benefits may be available.
- Work supports the development and commercialization of medical treatments and improved patient outcomes.
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