Senior Clinical Research Associate (Oncology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Senior Clinical Research Associate (Oncology): Managing and monitoring Phase I–IV clinical trials to ensure site compliance and data integrity with an accent on oncology studies and regulatory adherence. Focus on performing routine site visits, managing CAPA plans, and coordinating with site personnel to accelerate treatment delivery.
Location: Remote (Must be based in the US)
Company
is a global Contract Research Organisation (CRO) specializing in Phase I–IV clinical studies to accelerate regulatory pathways and patient access.
What you will do
- Perform routine site visits independently, including pre-study, initiation, interim monitoring, and closeout visits.
- Manage assigned sites to ensure compliance, adequate enrollment, and understanding of study requirements.
- Conduct CRF reviews, query generation, and resolution against established data review guidelines.
- Identify and escalate potential risks and implement corrective and preventive (CAPA) plans.
- Prepare documents for EC submissions and notifications, and translate study-related documents.
- Negotiate study budgets with investigators and assist in the execution of site contracts.
Requirements
- University degree, preferably in medical or life sciences, nursing, or a relevant healthcare field.
- 3-5 years of independent clinical trial monitoring experience in oncology.
- High level of knowledge of ICH GCP Guidelines and regulatory requirements.
- Excellent verbal and written communication, interpersonal, and negotiation skills.
- Ability to work independently and pro-actively within a matrix environment.
- Must possess a current, valid driver’s license.
Culture & Benefits
- Competitive salary and PTO entitlement.
- Comprehensive health insurance, including vision and dental plans.
- Pension plan to maximize savings and prepare for the future.
- Employee engagement and well-being initiatives.
- Training and development programs with a fast-paced career path progression.
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