9 дней назад
CRA 2, Oncology (Clinical Research)
90 200 - 150 400$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
CRA 2, Oncology (Clinical Research): Conducting on-site monitoring and managing oncology clinical trial sites in accordance with GCP, ICH, and regulatory requirements with an accent on site oversight, subject recruitment, study documentation, and data quality. Focus on evaluating site compliance, tracking enrollment and regulatory submissions, resolving data queries, and maintaining TMF and ISF records.
Location: Durham, North Carolina, United States of America
Salary: $90,200–$150,400 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 for oncology clinical trials.
- Support subject recruitment plans and track enrollment progress against project needs.
- Deliver protocol and study training and maintain communication with assigned sites.
- Evaluate site practices, protocol compliance, data quality, and adherence to GCP, ICH, and local regulations.
- Track regulatory submissions, approvals, CRF completion, data queries, and query resolution.
- Prepare monitoring reports, follow-up letters, action plans, and other study documentation while maintaining TMF and ISF records.
Requirements
- 1.5–2 years of relevant CRA experience, including on-site monitoring.
- Bachelor’s degree; a scientific or healthcare discipline is preferred.
- Experience with oncology clinical trial site monitoring.
- Knowledge of Good Clinical Practice, ICH guidelines, and applicable regulatory requirements.
- Ability to manage site communication, recruitment tracking, documentation, and study issue escalation.
Culture & Benefits
- Full-time employment with potential eligibility for incentive plans, bonuses, and health and welfare benefits.
- Work within a global clinical research and healthcare intelligence organization.
- Equal opportunity employment environment.
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