10 дней назад
Senior Clinical Research Associate, Early Clinical Development (Phase I)
90 200 - 175 100$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Clinical Research Associate, Early Clinical Development (Phase I) (Clinical Research/GCP): Monitoring and managing clinical sites for Phase I trials, ensuring protocol compliance, regulatory alignment, recruitment progress, and clinical data integrity with an accent on site monitoring, GCP, ICH guidelines, and essential document management. Focus on conducting site visits, resolving data and quality issues, coordinating study-specific training, and tracking enrollment, regulatory submissions, CRF completion, and TMF/ISF documentation.
Location: Carlsbad, CA, United States of America; West Coast, US
Salary: $90,200–$175,100 annualized base pay
Company
Clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries, supporting the development of medical treatments and improved patient outcomes.
What you will do
- Conduct site selection, initiation, monitoring, and close-out visits for Phase I clinical trials.
- Monitor site compliance with study protocols, Good Clinical Practice, ICH guidelines, regulatory requirements, and sponsor expectations.
- Support subject recruitment strategies, track enrollment, and monitor study progress against project goals.
- Deliver protocol and study-specific training and maintain communication with site personnel.
- Track regulatory submissions, CRF completion, data queries, essential documents, and site performance.
- Document visit outcomes and follow-up actions while collaborating with cross-functional project teams; support invoice collection and budget tracking when required.
Requirements
- Bachelor’s degree in life sciences or a health-related field, or equivalent experience.
- At least 1.5 years of on-site monitoring experience.
- Strong understanding of GCP, ICH guidelines, and regulatory requirements.
- Ability to travel as required by the project.
- Must be located on the US West Coast for this role.
Culture & Benefits
- Full-time employment.
- Work focused exclusively on Phase I early clinical development.
- Base pay varies according to qualifications, experience, location, and schedule.
- Potential incentive plans, bonuses, and health and welfare benefits may be available.
- Equal opportunity employment and an integrity-focused hiring process.
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