9 дней назад
Senior Clinical Research Associate 1
90 200 - 175 100$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Associate 1 (Clinical Research): Monitoring clinical trial sites and managing study data, documentation, recruitment, and regulatory submissions across therapeutic areas with an accent on Good Clinical Practice, protocol compliance, and site performance. Focus on conducting monitoring visits, resolving data queries, maintaining trial files, and escalating quality issues.
Location: Durham, North Carolina, United States of America
Annual base pay: $90,200–$175,100
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 accordance with the study protocol, Good Clinical Practice, and contracted scope.
- Support site recruitment plans, track enrollment, and manage ongoing communication with assigned sites.
- Deliver protocol and study training and address project expectations and operational issues.
- Evaluate site practices, regulatory compliance, data quality, and protocol adherence, escalating quality issues when needed.
- Track regulatory submissions, approvals, case report forms, data queries, and study progress.
- Maintain monitoring reports, action plans, follow-up letters, Trial Master File documentation, and Investigator Site Files.
Requirements
- At least 2 years of on-site clinical monitoring experience.
- Bachelor's degree in a scientific or healthcare discipline preferred; equivalent education, training, and experience may be accepted.
- Knowledge of applicable clinical research regulatory requirements.
- Knowledge of Good Clinical Practice and International Conference on Harmonization guidelines.
- Therapeutic and protocol knowledge in areas such as oncology, cardiovascular, renal, metabolic, CNS, diabetes, gastrointestinal, dermatology, or respiratory research.
- Ability to work in the Durham, North Carolina, United States location and perform on-site monitoring visits.
Culture & Benefits
- Full-time employment with a global clinical research organization.
- Health and welfare benefits may be available.
- Incentive plans, bonuses, or other compensation may be offered depending on the position.
- Equal opportunity employment practices.
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